louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01238523: Study of Tibial Shaft Fractures in Children
Official title: Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Shaft Fractures in Children
Keywords: tibia
shaft
fracture
children
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles Orthopaedic Hospital
First posted: 2010-11-10
Enrollment: 81
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).

The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study


Eligibility criteria: Inclusion Criteria:

* Patients between 4 and 14 years of age (open physis)
* Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
* All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern

Exclusion Criteria:

* Fractures with greater than 2 cm of initial shortening
* Open fractures
* Patients that have other orthopaedic medical issues such as hemophilia

Primary outcomes:
measure: The Activities Scale for Kids - Performance (ASK-P)
timeFrame: May 2007 - May 2010
Secondary outcomes:
measure: Time to Healing
timeFrame: May 2007 - May 2010
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Orthopaedic Hospital
state: California
Study officials:
References:
citation: Silva M, Eagan MJ, Wong MA, Dichter DH, Ebramzadeh E, Zionts LE. A comparison of two approaches for the closed treatment of low-energy tibial fractures in children. J Bone Joint Surg Am. 2012 Oct 17;94(20):1853-60. doi: 10.2106/JBJS.J.01728.
Clinical trial NCT02520323: The Lung Microbiome in Sarcoidosis
Official title: The Lung Microbiome in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects will be patients with sarcoidosis (involving any organ system), with non-sarcoid interstitial lung disease, and healthy controls.

Brief summary: The objective of this study is to determine the presence of bacterial species, and the immunologic and molecular mechanisms of granuloma formation that might be involved in the pathogenesis of sarcoidosis. The investigators will collect peripheral blood and bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung disease, and healthy volunteers to directly compare the bacterial species present and the characteristics of cells thought to be involved in granuloma formation.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sarcoidosis (30 subjects) or
* Clinical diagnosis of non-sarcoid interstitial lung disease (10 subjects) or
* Age-matched controls (30 subjects)
* Ability to provide informed consent

Exclusion Criteria:

* Any disease condition (such as anemia, unstable cardiac disease, etc.) that in the opinion of the subject's primary physician would put the patient at risk of harm from having 60 cc of blood drawn or for undergoing bronchoscopy for this study.
* Patients who are undergoing bronchoscopy for presumed infection.
* Pregnant women, women who may be pregnant, and women who are breastfeeding.
* Patients who have undergone lung transplantation.
* Persons who are unable or unwilling to undergo bronchoscopy, including those unable to be accompanied by a designated driver to the procedure.
* Persons who have taken antibiotics in the 90 days prior to consent.
* Known HIV, HCV, alcohol, or other substance abuse history.

Primary outcomes:
measure: Microbiome analysis
timeFrame: Baseline
Secondary outcomes:
measure: Measures of immunologic phenotype
timeFrame: Baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Eric S White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071923: Effect of Thyroid Disorders in Liver Diseases
Official title: Effect of Thyroid Disorders in Metabolic Fatty Liver Changes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fatty Liver Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid disorders and age above 18 years

Brief summary: Aims of the Research

1. To detect correlation between hyperthyroidism and non alcoholic fatty liver disease (NAFLD).
2. To detect hepatic risk in subclinical and clinical hypothyroidism .
3. To detect early liver disorders in thyroid disorders using fibroscan .

Detailed description: Non alcoholic fatty liver disease (NAFLD) has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries ,the overall prevalence of NAFLD worldwide was estimated to be 32.4%.prevalence increased significantly over time.

considering the increasing incidence of NALAD/NASH, especially in developed and developing countries, it is anticipated that cirrhosis due to these conditions may exceed other causes of cirrhosis in a near future..

Thyroid gland is involved in energy homeostasis, lipid and carbohydrate metabolism, regulation of body weight and adipogenesis.

In a clinical setting, subclinical hypothyroidism has been associated with metabolic syndrome, cardiovascular mortality and disturbance of lipid metabolism.

The prevalence of hypothyroidism was reported to 16.8% among patients with NAFLD/NASH.

In recent years, growing body of evidence has led to speculation on the association between NAFLD/NASH and thyroid dysfunction.

Therefore, understanding the pathophysiology, risk factors and new treatment options of NAFLD/NASH should be among the priorities in the field of hepatology

Eligibility criteria: Inclusion Criteria:

* The study will include thyroid patients over one year duration ( age above 18 years old

Exclusion Criteria:

1. History of liver failure or patient known to have congenital liver disease.
2. Medications associated with weight gain .
3. Patients who have diabetes mellitus.
4. patients who already have liver disease eg; chronic viral hepatitis, liver cirrhosis.
5. Patients on antistatin.

Primary outcomes:
measure: Detect correlation between hyperthyroid diseases and NASH .
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01449123: Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
Official title: An Open-label Single Site Single Dose Pilot Study Using Mannitol Challenge Test With the Purpose to Explore Treatment With Fixed Dose Combinations in Adult Subjects With Asthma in Primary Care in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
mannitol challenge test
Sweden
primary care
Lead sponsor: Mundipharma AB
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.

The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.

The hypothesis is that not all patients are well treated.


Eligibility criteria: Inclusion criteria

1. Males and females, age 18-65 years.
2. Subjects diagnosed with asthma.
3. Subjects with a baseline FEV1 of ≥70% of the predicted value.
4. Outpatients at primary clinic.
5. Subjects treated with a fixed dose combination for at least the last three months.
6. Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
7. Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.

Exclusion Criteria

1. Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
2. Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
3. Any history of hypersensitivity to mannitol challenge test.
4. Any contraindications to use of the diagnostic study medication.
5. Subjects who are unsuitable for other reason(s) in the opinion of the investigator.

Primary outcomes:
measure: Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response.
timeFrame: One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Höllviken
country: Sweden
facility: Näsets Läkargrupp i Höllviken
Study officials:
References:
Clinical trial NCT06344923: Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
Official title: Does Suturing the Peritoneum and Anterior Rectus Sheath Affect the Safety of Temporary Loop Ileostomy After Laparoscopic Anterior Rectal Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ileostomy - Stoma
Rectal Neoplasms
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.


Eligibility criteria: Inclusion Criteria:

* preventive ileostomy in laparoscopic rectal surgery

Exclusion Criteria:

* ileostomy due to anastomotic leak

Primary outcomes:
measure: postoperative complications related to ileostomy
timeFrame: after primary surgery to ileostomy closure (6 months after primary surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT03972423: Impact of a Transmission Checklist in Post Anesthesia Care Unit on Immediate Respiratory Complications
Official title: Impact of a Transmission Checklist in Post Anesthesia Care Unit on Immediate Respiratory Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Postoperative Complications
Anesthesia Complication
Keywords: checklist
postoperative complication
anesthesia
information transmission
care unit
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr. Frédéric MARTIN
First posted: 2019-06-03
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients admitted to PACU

Brief summary: This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted.

Detailed description: Communication and information transmission problems are responsible for the majority of serious adverse events. The use of a checklist in the operating theatre has demonstrated its benefit in terms of reducing morbidity and mortality Regarding transmissions between caregivers, numerous studies have shown the great difference between the medical data of a patient in their file and the information transmitted.

The authors recommend using checklists in order to standardise transmissions. This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted. On the other hand, no study has looked at the reduction of immediate postoperative complications in post anaesthesia care units (PACU).

Eligibility criteria: Inclusion Criteria:

* Male or Female over 18 admitted to PACU
* Patient having understood the aims and the methods of the research

  * Patient having expressed their consent to the use of their data.
  * Subject registered with or beneficiary of a social security scheme

Exclusion Criteria:

* Patient participating in another clinical study
* Acute or chronic respiratory insufficiency preoperatively
* Protected patient: adult under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or lactating women

Primary outcomes:
measure: arterial oxygen desaturation < 90%
timeFrame: event of at least 15 second duration
Secondary outcomes:
Other outcomes:
Locations:
city: Versailles
country: France
facility: Les Franciscaines Clinic
state: IDF
Study officials:
affiliation: Hospital
name: Frederic Martin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaulin F, Lopes T, Martin F. Standardised handover process with checklist improves quality and safety of care in the postanaesthesia care unit: the Postanaesthesia Team Handover trial. Br J Anaesth. 2021 Dec;127(6):962-970. doi: 10.1016/j.bja.2021.07.002. Epub 2021 Aug 5.
Clinical trial NCT03728023: A Study of AZD4205 in Healthy Adult Subjects
Official title: A Phase I, Randomized, Double Blind, Placebo Controlled 2-Parts Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD4205 Following Single and Multiple Ascending Dose in Healthy Adult Subjects, and to Assess the Effect of Food on the Pharmacokinetics of AZD4205
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
2. Female and/or male aged ≥18 \~ ≤ 45 years, with BMI ≥18\~≤ 28kg/m2.
3. Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception.
4. Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner.

Exclusion Criteria:

1. Evidence or reported history of clinically significant hematological (absolute neutrophil count \< 1.5 x 10\^3/μL; platelet count \< 100 x 10\^3/μL; hemoglobin \< 9 g/dL, INR \> 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator.
2. Infections
3. Received a live vaccine within 3 months before first dose of IP.

Primary outcomes:
measure: The number of subjects with adverse events
timeFrame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
measure: The number of subjects with abnormal laboratory parameters
timeFrame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
measure: The number of subjects with abnormal vital signs
timeFrame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
measure: The number of subjects with abnormal electrocardiogram
timeFrame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
Secondary outcomes:
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage clinical service
state: New Jersey
Study officials:
affiliation: Frontage Clinical Services, Inc.
name: Gregory J Tracey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008823: Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons
Official title: Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Virus Infection
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 907
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the population under study is children under 15 years of age, hospitalized for infection with influenza virus confirmed microbiologically during two consecutive seasons (September 15, 2014 to June 30, 2015) (September 15, 2015 to June 30, 2015). 2016).

Brief summary: This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed

Detailed description: A better knowledge in our environment of the characteristics of the Influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child

Eligibility criteria: Inclusion Criteria:

* Boys and girls under 15 years of age.
* With a clinical diagnosis of influenza virus infection.
* With infection by influenza virus confirmed microbiologically.
* Hospitalized more than 24 hours

Exclusion Criteria:

* Age equal to or greater than 15 years.
* That the clinical diagnosis is not influenza virus infection.
* Influenza virus not confirmed by microbiological diagnosis.
* Not hospitalized or hospitalized for less than 24 hours.

Primary outcomes:
measure: To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain.
timeFrame: 2014-2016
Secondary outcomes:
measure: Hospitalization rate by age groups (0-6 months, 6 months to 24 months, 2 to 6 years, 6 to 10 years and 10 to 15 years of age
timeFrame: 2014-2016
measure: Demographic characteristics of hospitalizations for influenza in children
timeFrame: 2014-2016
measure: Complications associated with influenza infection.
timeFrame: 2014-2016
measure: Related morbidity
timeFrame: 2014-2016
measure: Estimation of direct costs
timeFrame: 2014-2016
measure: Epidemiological characteristics of hospitalizations for influenza in children
timeFrame: 2014-2016
measure: Clinical characteristics of hospitalizations for influenza in children
timeFrame: 2014-2016
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Iis Biodonostia
state: Guipuzcoa
Study officials:
References:
Clinical trial NCT00727623: Mortality Analysis of ST Elevation Myocardial Infarction (STEMI) Patients in Belgium
Official title: Prospective Observational Study to Assess Predictors of in Hospital Mortality in STEMI Patients Admitted in Belgian Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Keywords: acute coronary syndrome
myocardial infarction
predictors of mortality
reperfusion therapy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Belgian Government
First posted: 2008-08-04
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ST elevation myocardial infarction admitted in Belgian hospitals.

Brief summary: The purpose of this observational study is to assess predictors of in-hospital mortality in patients with acute myocardial infarction admitted to Belgian hospitals.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of acute myocardial infarction with ST elevation or left bundle branch blok pattern on ECG

Exclusion Criteria:

* acute myocardial infarction as an acute complication of coronary intervention

Primary outcomes:
measure: all cause mortality
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: La Louviere
country: Belgium
facility: Centre Hospitalier de Jolimont
state: Hainaut
Study officials:
affiliation: University Hospital, Antwerp
name: Marc J Claeys, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gevaert SA, De Bacquer D, Evrard P, Convens C, Dubois P, Boland J, Renard M, Beauloye C, Coussement P, De Raedt H, de Meester A, Vandecasteele E, Vranckx P, Sinnaeve PR, Claeys MJ. Gender, TIMI risk score and in-hospital mortality in STEMI patients undergoing primary PCI: results from the Belgian STEMI registry. EuroIntervention. 2014 Jan 22;9(9):1095-101. doi: 10.4244/EIJV9I9A184.