louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04746417: Assessment of Skeletal Maturity Using Proximal Femoral Epiphysis in Patients With Scoliosis
Official title: Validation of the Assessment of Skeletal Maturity Using Femoral Head in Patients With Idiopathic Scoliosis and Its Clinical Implications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Scoliosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented to our tertiary scoliosis clinic with referral for specialist consultation of scoliosis - we particularly focus on scoliosis of idiopathic nature

Brief summary: This study aims to explore the use of proximal femoral head for the assessment of skeletal maturity in patients with idiopathic scoliosis. The aim is to validate the use of the stages of proximal femoral epiphyseal closure in assessing pubertal growth landmarks in this patient cohort. The grading system of this skeletal maturity index will be established and its reliability and reproducibility in clinical use will be examined.

Detailed description: There are multiple skeletal maturity measures currently in use which were established with reliability in assessing growth. The advantages and shortcomings of each index was previously examined. This study aims to explore the use of proximal femoral epiphysis, which is in close proximity of the radiographic field of the spine, in assessing the growth status of patients with idiopathic scoliosis. The stages of the proximal femoral epiphyseal ossification has been established with specific definitions. The reliability and reproducibility of using these gradings will be examined by orthopaedic surgeons. Subsequently, the assessment of different pubertal growth landmarks using these gradings will be validated, and to see whether these gradings can provide indications of peak growth and growth cessation. Finally, the relationships of such growth assessment using this proximal femoral epiphysis ossification (PFEO) system and the curve progression in idiopathic scoliosis will be studied.

Eligibility criteria: Inclusion Criteria:

* Idiopathic scoliosis
* Open triradiate cartilage or open distal radius epiphysis without capping

Exclusion Criteria:

* Non-idiopathic scoliosis
* Patients with growth hormone deficiency or developmental delay
* Patient has not reached skeletal maturity
* Defaulted and lost to follow-up

Primary outcomes:
measure: PFEO stages
timeFrame: 8 to 18 years
Secondary outcomes:
measure: Growth parameters
timeFrame: 8 to 18 years
measure: Growth parameters
timeFrame: 8 to 18 years
Other outcomes:
measure: Curve progression
timeFrame: 8 to 18 years
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent Children's Hospital
Study officials:
References:
Clinical trial NCT01122017: A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
Official title: A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genu Varum
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.

Detailed description: There are various methods for correcting varus deformity; therefore the best surgical method must be individualized. We concluded that in a varus knee where only correction in the coronal plane without patella infra, changes in Q- angle, tibial plateau inclination is all that is needed, a retro- tubercle medial opening- wedge osteotomy is the preferred approach.

Eligibility criteria: Inclusion Criteria:

* symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury

Exclusion Criteria:

* fractures through compartments of the knee or the patella
* osteoarthritis other than in the medial compartment
* 10 degrees or more extension lag
* tibial malrotation

Primary outcomes:
measure: The proportion of patellar length (in mm)to the patellar tendon length (in mm)
timeFrame: up to 13 months
measure: The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
timeFrame: up to 13 months
Secondary outcomes:
measure: Quadriceps angle in degree
timeFrame: up to 13 months
measure: Inclination of proximal tibial plateau in degree
timeFrame: up to 13 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Reza Abbasian, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04151017: Efficacy of Autologous Fibrin Glue in Pterygium
Official title: Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2019-11-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.

OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.

This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.


Eligibility criteria: Inclusion Criteria:

* nasal primary pterygium

Exclusion Criteria:

* relapsed pterygium
* patients with a history of previous eye surgery
* patients with glaucoma using hypotensive eye drops
* eye surface diseases
* eye allergy
* diabetic patients,

Primary outcomes:
measure: Pterygium Recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Autograft Retraction
timeFrame: Postoperative day 1, 7, 21 and 30
measure: Postoperative Pain
timeFrame: Postoperative day 1, 7, 21 and 30
measure: Graft Edema
timeFrame: Postoperative day 1, 7, 21 and 30
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Diane Marinho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03529617: Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
Official title: Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pharmacokinetics
Liposomal Amphotericin B
Critically Ill Patients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2018-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. critically ill patients treated with L-AmB
2. hematology patients treated with L-AmB

Brief summary: This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.

Detailed description: This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB.

The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day.

Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Treatment with L-AmB
* Admitted to an ICU or Hematology ward

Exclusion Criteria:

* DNR 2 or 3
* Pregnant or lactating women
* Previous documentation of intolerance/sensitivity to L-AmB

Primary outcomes:
measure: Plasma exposure and PK parameters
timeFrame: July 2020
Secondary outcomes:
measure: Covariates
timeFrame: July 2020
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Isabel Spriet, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650917: Acupoint Massage Combined With Ear Point Pressing Beans
Official title: Explore the Application Effect of Acupoint Massage Combined With Ear Point Pressing Beans in the Remission Stage of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Hai'an Hospital of TCM001
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group and control group, with 60 cases in each group.The patients in both groups were treated with salmeterol and fluticasone inhalation powder once a day, twice a day. The patients in the control group were treated with acupoint massage on this basis. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time.The patients in the experimental group were treated with ear point pressing beans on the basis of the control group. The ear point pressing beans is performed once a day from Monday to Friday. Changes in pulmonary function and asthma control were observed before and after treatment in the two groups were observed, and forced expiratory volume 1 second (FEV1),forced expiratory vital capacity (FVC), FEV1/FVC, asthma control test scale (ACT) score were compared.


Eligibility criteria: Inclusion Criteria:

* The patient met the diagnostic criteria of asthma remission in the Guidelines for prevention and treatment of bronchial asthma；
* 1\~18 years old, course of disease \> 1 year;
* Patients with complete clinical data and able to cooperate with treatment.

Exclusion Criteria:

* Patients with other cardiopulmonary system diseases or myasthenia gravis;
* Eczema, ulcer or other symptoms in the auricle or skin;
* Illiteracy, cognitive, language or communication disorders;
* The patient has taken medication for asthma treatment within 3 months.

Primary outcomes:
measure: Pulmonary function
timeFrame: 1 minutes
measure: Asthma control
timeFrame: 1 hour
measure: Efficacy assessment
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01785017: The Effects of a Standardized Management Plan on Children With Critical Asthma
Official title: The Effects of a Standardized Clinical Assessment Management Plan (SCAMP) on Clinical Outcomes in Children With Critical Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Asthma
Keywords: critical
asthma
children
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 273
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized children 2 years and older requiring intensive care treatment for asthma

Brief summary: A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome.

Detailed description: A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. However the effects of the Critical Asthma SCAMP on the clinical outcomes in children with critical asthma are unknown. This study will assess the effectiveness of the SCAMP by comparing retrospective data from medical records in children with critical asthma to prospective clinical PPSQ SCAMP outcome data obtained during the QA process of the SCAMP. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome. There are three specific pathways in the Critical Asthma SCAMP. The primary outcome measure is the length of intensive care length of stay (defined as time to every 2 hr intermittent albuterol nebulization) for all three pathways. The secondary aim is to validate a clinical asthma score to direct critical asthma therapies. To achieve this goal we will determine the relationships of the driver(s) of the SCAMP which includes Boston Children Hospital (BCH) Asthma Severity Score \[HASS\] and non-invasive measures of pCO2 to standard measures of severity of asthma (blood gases and peak flow measurements).

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization

Primary outcomes:
measure: Time from initialization of continuous albuterol to time of final every 2 hr albuterol nebulization
timeFrame: The time to intermittent q2 hr albuterol nebulization from continuous albuterol during hospitalization within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children Hospital
name: Jackson Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04639817: Trimethoprim-Sulfamethoxazole vs Levofloxacin as Targeted Therapy for Stenotrophomonas Maltophilia Infections: a Retrospective Cohort Study
Official title: Trimethoprim-Sulfamethoxazole or Levofloxacin? A Retrospective Cohort Study of Targeted Therapy for Stenotrophomonas Maltophilia Blood Stream and Lower Respiratory Tract Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stenotrophomonas Infection
Keywords: Stenotrophomonas maltophilia, Stenotrophomonas, Levofloxacin, TMP/SMX, Trimethoprim-sulfamethoxazole
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: Duke University
name: Emory University
First posted: 2020-11-23
Enrollment: 1621
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: Adult inpatients with Stenotrophomonas maltophilia blood stream or lower respiratory tract infection

Brief summary: This study seeks to compare mortality outcomes of levofloxacin and trimethoprim-sulfamethoxazole treated patients who have Stenotrophomonas maltophilia blood stream or lower respiratory tract infections by retrospectively analyzing a propensity-matched cohort from a large dataset of electronic health record data.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Stenotrophomonas maltophilia culture positive from blood or the following specified respiratory tract sites: sputum, tracheal aspirate, bronchoalveolar lavage and protected bronchial brush washings
* Received either levofloxacin or TMP/SMX targeted therapy
* Those patients that received empiric therapy with a consistent medication (for example, levofloxacin empirically in the levofloxacin targeted therapy cohort) were included

Exclusion Criteria:

* Received antimicrobial other than TMP/SMX and levofloxacin, with known activity against Stenotrophomonas maltophilia (the list of antimicrobials that fit this exclusion criteria is: erythromycin, moxifloxacin, ciprofloxacin, minocycline, tigecycline, doxycycline, eravacycline, ceftazidime, cefepime, ticarcillin-clavulanate, cefiderocol, colistin, and chloramphenicol)
* Received inconsistent empiric therapy (for example, levofloxacin empirically in the TMP/SMX targeted therapy cohort) will be excluded from analysis
* Cystic fibrosis code present
* Organism resistant to therapy received

Primary outcomes:
measure: Death or hospice discharge
timeFrame: In-hospital
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Single encounter
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health (NIH)
name: Sameer Kadri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06873217: Acupuncture for Dizziness and Vertigo in Emergency Department
Official title: Acupuncture for Dizziness and Vertigo in Emergency Department: a Single-center, Self-control, Observational Clinical Study During 2019-2023
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness and Vertigo
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 345
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted at China Medical University Hospital, Taiwan, between January 2019 and December 2023, with 345 patients diagnosed with dizziness and vertigo (ICD-10 codes R42 and H81). Patients received acupuncture in addition to standard Western medical care. The Visual Analogue Scale (VAS) was used to assess symptom severity before and after the acupuncture intervention. Secondary analyses explored the influence of ICD-10 classification, gender, and seasonality on treatment outcomes.


Eligibility criteria: Inclusion Criteria:

Patients who were diagnosed as ICD number R42 and H81

Exclusion Criteria:

Patients who were not suitable to accept acupuncture or refused to accept acupuncture

Primary outcomes:
measure: Visual Analogue Scale (VAS) change
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
Clinical trial NCT03569917: Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
Official title: Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients Receiving Ceftriaxone in Hospital Emergency Unit
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients receiving Ceftriaxone 1 gram or 2 grams per day during their presence in emergency unit of hospital whatever their medical condition, will be included.

Rectal swabs will be collected at inclusion and at days 5 and 30 to perform analysis.

Analysis will be performed to characterize gut microbiome in order to detect intestinal microbiome profiles significantly associated with protection against colonization by third generation cephalosporin resistant Enterobacteriae.


Eligibility criteria: Inclusion Criteria:

* Age 18 years
* Able to comply with study requirement and to provide informed consent
* Outside the context of tutorship and / or guardianship, affiliated to the Social Security Regime and having consented to participate in the ARCMI study.
* Patient receiving ceftriaxone (1 gram or 2 grams per day) in the emergency department

Exclusion Criteria:

* Patients with acute anorectal pathology incompatible with the swabbing strategy or digital rectal examination.
* Prescription of another dosage of ceftriaxone (more than 2 grams per day)
* Patient with inflammatory bowel disease
* Allergy or contraindication to betalactamines and cephalosporins

Primary outcomes:
measure: Identification of gut microbiome biomarkers
timeFrame: 30 days
Secondary outcomes:
measure: Identification of gut microbiome biomarkers
timeFrame: 5 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes university Hospital
Study officials:
References: