louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02247778: Surgical Innovations in Treatment of Clavicle Fractures
Official title: Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication
Keywords: clavicle
surgical intervention
mini-incision
plate osteosynthesis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.

The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.

Detailed description: Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.

The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a prospective observational protocol was chosen.

Eligibility criteria: Inclusion Criteria:

all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent

Exclusion Criteria:

all other patients

Primary outcomes:
measure: area of paresthetic skin
timeFrame: 12 month
Secondary outcomes:
measure: Time to fracture healing
timeFrame: 12 month
measure: Postoperative shoulder function
timeFrame: 12 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
name: Chlodwig Kirchhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beirer M, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
Clinical trial NCT02848378: Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Periodontal Disease
Official title: The Levels of Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Gingival Crevicular Fluid in Periodontal Disease and Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Periodontal Disease
Keywords: Advanced Oxidation Protein Products
Gingival crevicular fluid
Monocyte chemoattractant protein-1
Periodontal Disease
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included.

Brief summary: This study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. In each participant, four sites are identified for gingival crevicular fluid samples.

Detailed description: Oxidative stress is the disequilibrium between the formation of free radicals and antioxidant defense mechanisms via damaging cellular macromolecules (DNA, protein, lipid, etc..) which are susceptible to oxidative damage.

Advanced oxidation protein product is identified as a new marker of protein oxidation.

Monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and macrophages.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic periodontitis and gingivitis

Exclusion Criteria:

* Systemic illnesses
* Any medications known to affect the periodontium
* Pregnancy and lactation

Primary outcomes:
measure: Advanced oxidation protein product (nmol)
timeFrame: Before periodontal treatment
Secondary outcomes:
measure: Monocyte chemoattractant protein-1(pg)
timeFrame: Before periodontal treatment
measure: The probing depth (mm), clinical attachment level (mm), plaque index scores (0-3) and gingival index scores (0-3)
timeFrame: Before periodontal treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02225678: Minimally Invasive Biomarker for Asthma Disease Severity
Official title: Feasibility of Using an Eosinophil-Specific Biomarker-(Eosinophil Peroxidase) in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Healthy
Keywords: healthy volunteers
asthma
sputum eosinophils
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asthma patients healthy volunteers

Brief summary: Can a clinical test be developed that could help manage asthma symptoms?

Detailed description: Project goals:

Develop a point-of-service assay to assess eosinophilic airway inflammation

Proposal Specific Aims:

1. To establish the infrastructure and test the feasibility of sputum collection in a clinical setting as a minimally invasive patient sampling process for biomarker testing
2. To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into a clinic-friendly assessment that does not require sophisticated laboratory equipment

Eligibility criteria: Asthma subjects:

Inclusion

* Provider diagnosed asthma
* FeNO\>50 ppb
* FEV1 \> 1.0 Liter

Exclusion

* COPD by history
* Bronchiectasis by history
* Pregnant participants

Normal subjects:

Inclusion

- Age matched to asthma subjects

Exclusion

* Any eosinophil disorder by history
* Asthma by history
* Rhinitis or sinusitis by history

Primary outcomes:
measure: Sputum Induction
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: James Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01439178: Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Official title: Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complications of Diabetes Mellitus
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 28
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: Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal bevacizumab (IVB) in proliferative diabetic retinopathy.

Design: Prospective, open-label, controlled, randomized interventional clinical trial.

Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.

Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV. Aqueous humor samples were taken from anterior chamber just before IVB and at the time of surgery. Multiplex cytokine array were used to assay various cytokines


Eligibility criteria: Inclusion Criteria:

* Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)

Exclusion Criteria:

* Eyes with any pharmacologic intervention on study eye within 6 months
* Eyes with panretinal photocoagulation on study eye within 3 months
* Eyes with any pharmacologic intervention on fellow eye within 3 months,
* History of ocular diseases other than diabetic retinopathy
* History of PPV on study eye
* History of systemic thromboembolic events including myocardial infarction and cerebrovascular accidents.

Primary outcomes:
measure: intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay
timeFrame: At day 2 after IVB in Group 1, day 7 after IVB at group 2.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's hospital
Study officials:
References:
Clinical trial NCT06345378: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII)
Official title: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of the Admissions of Patients Accessing the PS: Construction and Validation of an Algorithm Based on Computerised Databases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Quality of Care
Evaluation
Emergency Departments
Appropriateness
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients entering Emergency Department represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Brief summary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Detailed description: The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Exclusion Criteria:

* Voluntary removal of the patient;
* Sending home with instructions to return for further services

Primary outcomes:
measure: Algorithm creation
timeFrame: September 2020 - January 2024
measure: Algorithm validation
timeFrame: February 2024 - December 2024
measure: Algorithm application
timeFrame: January 2025 - December 2027
measure: Appropriateness estimation
timeFrame: January 2025 - December 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
state: BG
Study officials:
References:
Clinical trial NCT03149978: Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
Official title: Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced Rectal Cancer
Keywords: Neoadjuvant Chemoradiation
treatment effect prediction
metabonomics
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage T3 or T4 and/or N+ rectal adenocarcinoma cancer eligible for neoadjuvant chemoradiation

Brief summary: This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer


Eligibility criteria: Inclusion Criteria:

1. history of primary rectal cancer with distance from anal verge being less than 12 cm;
2. histologically confirmed adenocarcinoma;
3. initial pathological stage of T3 or T4 and/or N+;
4. no history of initial distant metastases;
5. Karnofsky Performance Status score of ≥75
6. ≥18 years;≤75 years
7. sign the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. serious medical illness
3. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

Primary outcomes:
measure: TRG
timeFrame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary outcomes:
measure: Pathologic Complete Response
timeFrame: Surgery scheduled 6-8 weeks after the end of chemoradiation
measure: Local Control rate
timeFrame: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
measure: Disease-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 10 years
measure: Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: Jia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2.
Clinical trial NCT03690778: The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Hyperlipidemias
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2.
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
* Subject who has the ability and willingness to participate the whole period of trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* 100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
* AST or ALT \> X 2 UNL
* Total bilirubin \> 2.0 mg/dL
* CK \> X 2 UNL
* eGFR \< 60 mL/min/1.73m2
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Primary outcomes:
measure: AUCt of Metformin and rosuvastatin
timeFrame: 48 hours
measure: Cmax of Metformin and rosuvastatin
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT01641978: Study of Glasgow Coma Scale in Neurological Patients
Official title: Study of Interobserver Correlation of Glasgow Coma Scale in Critical Neurological Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Individuality
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neurologic patients

Brief summary: The assessment of the level of consciousness in patients admitted to intensive care units (ICU) can be complicated because the variables that are evaluated can be interpreted in a different way by different observers.

The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses and assess whether professional experience change the results. Secondary objective: to determine interobserver agreement in each of the three components (motor response, verbal and eye opening) of the GCS

Detailed description: Prospective observational study conducted in a multi-unit 18 beds, neurological and / or neurosurgical patients are included. Variables: Demographic, reason for admission, overall and its components GCS. The neurological assessment was performed by a minimum of 3 nurses. One of them applied algorithm and evaluation technique and all agreed independently valued response to stimuli. Interobserver agreement measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) of 95%. This study was approved by the Ethics Committee of Clinical Trials hospital.

Eligibility criteria: Inclusion Criteria:

* neurologic patients

Exclusion Criteria:

* pregnants, under-ages

Primary outcomes:
measure: Interobserver Correlation
timeFrame: 1 year
Secondary outcomes:
measure: Severity in Glasgow Coma Scale (GCS) by Groups.
timeFrame: 1 year
measure: Years of Professional Experience for Nurses in Critical Care
timeFrame: 1 year
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe
name: Susana Arias, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921188: The Effect of Prior Learning on Word Learning
Official title: Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Language Development Disorders
Keywords: Late Talkers
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use treatment effect sizes to compare children to themselves (treatment v. control) and across groups (More Familiar Sounds v. Less Familiar Sounds).
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.

Detailed description: Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.

Eligibility criteria: Inclusion Criteria:

* Native English Speaking
* Pass pure tone hearing screening or medical report of normal hearing
* 2-3 Years of age at start of study
* MCDI expressive scales \<10th percentile

Exclusion Criteria:

* Parental reports of other diagnoses
* Enrolled in concurrent treatment elsewhere
* Nonverbal IQ \<75 as measured by the Bayley scales
* Parents unable to consistently bring child to treatment sessions

Primary outcomes:
measure: Treatment Effect Size
timeFrame: Change from baseline through treatment, which will average an 8-week time frame.
measure: Number/Rate of Words Learned
timeFrame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary outcomes:
measure: Post Treatment Retention
timeFrame: Change from end of treatment to follow up, which will average 4-6 weeks.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Mary Alt, PhD
role: PRINCIPAL_INVESTIGATOR
References: