louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03736278: Characteristics of Tuberculosis Infection in Rheumatic Disease
Official title: Retrospective Analysis of Tuberculosis in Rheumatic Diseases for Epidemiology, Risk Factors, Disease Presentation, Complications, Treatment, and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Autoimmune Diseases
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of rheumatic disease

Brief summary: A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.


Eligibility criteria: Inclusion Criteria:

* The patients with International Classification of Diseases (ICD) codes of rheumatic diseases during 2006-2017
* Definite evidence of tuberculosis infection

Exclusion Criteria:

* HIV, malignancy, not follow-up rheumatic disease in National Taiwan University Hospital, younger than 20-year-old, refusing attend research

Primary outcomes:
measure: Mortality
timeFrame: approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chiao-Feng Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02146378: Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Vyndaqel Capsules Special Investigation -Investigation on Long-term Use-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transthyretin Familial Amyloid Polyneuropathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of this surveillance are all patients who received Vyndaqel.

Brief summary: The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions \[ADRs\]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

Detailed description: Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered

Eligibility criteria: Inclusion Criteria:

The subjects of this surveillance are all patients who received Vyndaqel.

Exclusion Criteria:

Patients not receive Vyndaqel.

Primary outcomes:
measure: Percentage of Participants With ADRs in This Study
timeFrame: 3 years (However, the period for participants who started to receive Vyndaqel capsules 20mg after May 2018 was 1.5 years.)
Secondary outcomes:
measure: Change From Baseline in the NIS-LL Score
timeFrame: Week 78, Week 156
measure: Change From Baseline in the TQOL Score of the Norfolk QOL-DN
timeFrame: Week 78, Week 156
measure: Change From Baseline in mBMI
timeFrame: Week 26, Week 52, Week 78, Week 104, Week 130, Week 156
measure: Time Course of Ambulatory Status
timeFrame: Week 156
measure: Change From Baseline in the Total Neurological Assessment Score
timeFrame: Week 52, Week 104, Week 156
measure: Assessment of Survival Time for Death From Any Cause
timeFrame: 3 years (However, the period for participants who started to receive Vyndaqel capsules 20mg after May 2018 was 1.5 years.)
measure: Assessment of Survival Time for Death Associated With ATTR-PN
timeFrame: 3 years (However, the period for participants who started to receive Vyndaqel capsules 20mg after May 2018 was 1.5 years.)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ishii T, Hirano Y, Matsumoto N, Takata A, Sekijima Y, Ueda M, Ando Y. Characteristics of Patients with Hereditary Transthyretin Amyloidosis and an Evaluation of the Safety of Tafamidis Meglumine in Japan: An Interim Analysis of an All-case Postmarketing Surveillance. Clin Ther. 2020 Sep;42(9):1728-1737.e6. doi: 10.1016/j.clinthera.2020.07.001. Epub 2020 Aug 12.
Clinical trial NCT06797778: Oral Health Promotion Program in Schools in Polígono Sur
Official title: Oral Health Promotion Program in Schools in Polígono Sur
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Educational and Preventive Session for Dental Caries
Oral Diseases
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 396
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschool and primary school children in schools in Polígono Sur.

Brief summary: The objective of this observational study is to evaluate oral health before and after conducting an educational session on oral hygiene in schoolchildren from 3 schools in the Polígono Sur of Seville.

The main questions it aims to answer are:

* To find out the needs of schoolchildren for oral treatment.
* To analyse whether the educational sessions carried out serve to improve the oral health of schoolchildren.

The researchers will compare the results of different academic years to see if it serves to improve.

The participants are examined at the school during the school year. The educational sessions are carried out at the school during the school year.


Eligibility criteria: Inclusion Criteria:

* Schoolchildren whose legal guardians agree to participate

Exclusion Criteria:

* Schoolchildren whose legal guardians do not consent to participate

Primary outcomes:
measure: Prevalence of dental caries
timeFrame: pre-intervention and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
References:
Clinical trial NCT02979171: Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Difficult Airway
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.


Eligibility criteria: Inclusion Criteria:

* Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery

Exclusion Criteria:

* High aspiration risk, who take more than 4 hours surgery
* Body mass index greater than of 35 kg/m²
* Disease related to the cervical spine
* The mouth opening is less than 20 mm

Primary outcomes:
measure: insertion time and attempts in min.
timeFrame: through study completion, an average of 6 months
measure: oropharyngeal leak pressure in cmH20.
timeFrame: through study completion, an average of 6 months
measure: fiberoptic view grade by Brimacombe and Berry bronchoscopy score
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Science University
state: Şişli
Study officials:
References:
Clinical trial NCT01625078: Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
Official title: Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Baska Mask Efficacy and Safety in Children
Keywords: Baska Mask
Supraglottic airway device
Children
Pediatric
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.


Eligibility criteria: Inclusion Criteria:

* consent
* BMI 15-35
* weight over 30kg or age 8-16 yrs
* non-urgent surgery of planned duration up to 2 hrs

Exclusion Criteria:

* neck pathology
* previous or anticipated problems with the upper GI or upper airway
* increased risk of gastric aspiration
* expected difficult airway

Primary outcomes:
measure: Device insertion success rate
timeFrame: within 30 minutes of induction of general anesthesia
measure: device airway leak pressure
timeFrame: within 10 minutes of successful device placement
Secondary outcomes:
measure: airway stability
timeFrame: within 30 minutes of device placement
measure: ease of device placement
timeFrame: within 30 minutes of induction of general anesthesia
measure: complications during the anesthetic
timeFrame: from the start of device insertion untill discharge from recovery, an expected average of 2 hours
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospitals
Study officials:
affiliation: UCHG
name: Michael Scully, FFARCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02557971: Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.

Brief summary: This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.


Eligibility criteria: Inclusion Criteria:

-Patients treated with BOTOX® for Overactive Bladder.

Exclusion Criteria:

* Received botulinum toxin formulations other than BOTOX® in the bladder.
* Had symptoms of OAB associated with a neurological condition.
* Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

Primary outcomes:
measure: Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization
timeFrame: 12 Weeks
measure: Length of Time of Clean Intermittent Catheterization (CIC) Use
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percentage of Participants with Urinary Tract Infection (UTI)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Irvine
country: United States
facility: Capital Region Urology
state: California
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Richmond
country: United States
facility: Virginia Women's Center Inc.
state: Virginia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05339971: Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation
Official title: Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation - A Pilot Study on 10 Patients With Histological Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Augmentation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.


Eligibility criteria: Inclusion Criteria:

* single tooth gap in need of lateral bone augmentation prior to implant installation

Exclusion Criteria:

* untreated periodontal disease
* systemic disease and/or medication intake with significant effect on bone healing

Primary outcomes:
measure: Histomorphometry
timeFrame: at implant installation (approximately 6 months after augmentation)
measure: Radiographic
timeFrame: 6 months after block augmentation
measure: Radiographic
timeFrame: 12 months after block augmentation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01330771: Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP
Official title: Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-04-07
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females affected by sterility able to undergo IVF

Brief summary: To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins


Eligibility criteria: Inclusion Criteria:

* Women aged 18-38 years
* Body mass index (BMI) between 18 and 30
* Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
* Testosterona, FSH (follicle-stimulating hormone), LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
* No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria:

* Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
* Data suggestive of possible ovarian failure
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 30 days
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 16 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT02070471: Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Official title: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intravenous Single Injection LC28-0126 Immediately Before PCI (Percutaneous Coronary Intervention) in Patients With STEMI(ST-segment Elevation Myocardial Infarction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ST-segment Elevation Myocardial Infarction
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 75
* Within 12 hours after the onset of chest pain
* ST-segment elevation of more than 0.1 mV in two contiguous leads or new LBBB(left bundle-branch block) patients
* Signed for written informed consent

Exclusion Criteria:

* Left Main disease
* Multi-vessel disease

Primary outcomes:
measure: AUC of CK-MB for 72 hours post PCI
timeFrame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Secondary outcomes:
measure: AUC of Troponin I and CK for 72h post PCI
timeFrame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
measure: Infarct size and myocardial function assessed by CMR and Echocardiogram
timeFrame: Day 4, 30
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04806971: Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms in Periodontitis
Official title: Association Between Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms and Stage III Grade B/C Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Polymorphism, Restriction Fragment Length
Keywords: Vitamin D receptor
Polymorphism
Periodontitis,
Interleukin-1B
Interleukin-1A
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 subjects were recruited from the Marmara University, Faculty of Dentistry, Clinics of Periodontology

Brief summary: Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis.

Methods: Individuals who were found to be systemically and periodontally healthy (N = 100) after clinical and radiographic examination and who were diagnosed with Stage III Grade B / C periodontitis (N = 100) were included in the study. Gingival index, Plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with Real Time Polymerase Chain Reaction.

Detailed description: In this study we recruited 200 participants from the Periodontology Clinics. Periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. Genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by Real Time Polymerase Chain Reaction.Statistical analysis was done by the statistical software package SPSS v16. SNPassoc.

Eligibility criteria: Inclusion Criteria:

systemically healthy, previously untreated periodontitis patients

Exclusion Criteria:

presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.

Primary outcomes:
measure: IL-1A gene polymorphism
timeFrame: baseline
measure: Interleukin-1B gene polymorphism
timeFrame: baseline
measure: Vitamin D Receptor gene polymorphism
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University
state: Maltepe
city: İstanbul
country: Turkey
facility: Marmara University Dental Faculty Periodontology Department
Study officials:
References: