louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04039776: EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS
Official title: EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patello Femoral Syndrome
Keywords: CT
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism

Detailed description: The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism.

Young patients with patellofemoral joint pathology, for which a diagnostic examination is necessary in order to determine a possible surgical indication, will be included in this pilot study, and will be evaluated using the "Cone Beam Computed Tomography "(CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients, between 18 and 50;
2. Pathology or suspected patellofemoral joint pathology in which a CT examination is required for a diagnostic examination;
3. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of understanding and will;
2. Pregnant women;
3. Patients with history of previous fractures of the knee.
4. BMI\> 40.

Primary outcomes:
measure: Distance between tibial tuberosity and trochlear sulcus
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
References:
Clinical trial NCT02611076: Smoking-cessation: A Spanish-Language Clinical Trial
Official title: Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Dependence
Keywords: smoking cessation
self-help
Spanish language
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
name: University of Miami
First posted: 2015-11-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.

Detailed description: Study Aim 1: To transcreate the existing English-language 10 "Stop Smoking for Good" booklets and accompanying 9 supportive "My Story" pamphlets into a series of culturally relevant and acceptable materials for Spanish-speaking smokers who prefer to receive health information in Spanish. The adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of Hispanic/Latino smokers representing diverse subcultural groups.

Study Aim 2: To test the efficacy of the self-help intervention developed in Study I among Spanish-speaking smokers in a randomized controlled trial. Participants (500) will be randomized to receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention or usual care (UC) comprising an existing booklet from NCI. Investigators hypothesize SS-SP will produce higher abstinence rates than UC through 24 months.

Secondary Aim: Test moderator variables to improve targeting the intervention. Moderator analyses will be exploratory, without strong a priori hypotheses.

Eligibility criteria: Inclusion Criteria:

* All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish.
* Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish.
* ≥ 1 year history of smoking
* Smoking ≥ 5 cigarettes per week
* Age ≥ 18 years
* Not currently enrolled in a face-to-face smoking cessation program

Primary outcomes:
measure: Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials
timeFrame: Up to 12 months
measure: Study II: Rate of Smoking Cessation
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Vani N. Simmons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636376: Effects of Head Elevation on Intracranial Pressure in Children
Official title: Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury
Keywords: elevated intracranial pressure
inadequate cerebral perfusion
secondary brain damage
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 18
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Head injury is the most common cause of mortality and acquired disability in childhood. It is common to elevate the head of patients at risk for increased intracranial pressure, although it is not clear if it is always beneficial. Every severe pediatric traumatic brain injured patient will have an optimal head position that prevents rising pressure in the brain.

Detailed description: Head injury is the most common cause of mortality and acquired disability on childhood. Management of children at risk for intracranial hypertension is both complex and increasingly controversial. Also, effect of head position on intracranial pressure, cerebral perfusion pressure, adn cerebral venous outflow in the pediatric population has not been studied. We will examine the effect of head positioning on ICP, CPP, and cerebral venous outflow in pediatric patients at risk for intracranial hypertension. The hypothesis is that ICP will be reduced with improvement in cerebral venous outflow by each patient having their own optimal head position.

Eligibility criteria: Inclusion Criteria:

* Neonates, children, and adolescents
* Intracranial pressure monitor in place

Exclusion Criteria:

* Severe multiorgan system failure
* Hemodynamic instability sufficient to preclude changes in head position

Primary outcomes:
measure: ICP will be reduced with improvement in cerebral venous outflow which is dependent on intravascular volume status and intrathoracic pressure and each will have their own optimal head position.
timeFrame: As long as ICP is being monitored.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jimmy Huh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02556476: Cost Effectiveness Analysis of Critical Care in Resource Limited Setting
Official title: Cost Effectiveness of Intensive Care in a Low Resource Setting: Prospective Cohort of Medical Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: critical care
intensive care
health related quality of life
cost benefit analysis
Lead sponsor: University of Sarajevo
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.

Brief summary: The purpose of this study was to examine the cost effectiveness of critical care in a middle income country with limited resources.

The main study hypothesis was that critical care is cost effective in low resources setting.

Detailed description: The investigators objective was to calculate the cost effectiveness of treatment of critically ill patients in a medical ICU of a middle income country with limited access to ICU resources.

Methods: Consecutive critically ill medical patients treated in a recently established medical ICU in Sarajevo, Bosnia and Herzegovina, were prospectively recorded and a subsequent cost utility analysis of intensive care in comparison to hospital ward treatment from the perspective of health care system was performed. Incremental cost effectiveness was calculated using estimates of ICU versus non-ICU treatment effectiveness based on a formal systematic review of published studies. Decision analytic modeling was used to compare treatment alternatives. Sensitivity analyses of the key model parameters were performed.

Eligibility criteria: Inclusion Criteria:

* patients treated between June 1 2011 and June 29 2012 in the medical ICU

Exclusion Criteria:

* Patients who stayed in the ICU less than 24 hours and
* hospital readmissions

Primary outcomes:
measure: survival
timeFrame: one year after hospital release
Secondary outcomes:
measure: mortality
timeFrame: 30 days and 60 days after critical illness onset and one year after hospital release
measure: health related quality of life (HRQOL)
timeFrame: one year after hospital release
Other outcomes:
Locations:
Study officials:
affiliation: Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and Herzegovina
name: Hajrunisa Cubro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA
name: Ognjen Gajic, MD, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00863876: Comparison of WaveLight Analyzer and Alcon LadarWave
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keratoconus
Keywords: wavefront measurements of the entire eye
Lead sponsor: WaveLight AG
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy patients and patients following surgery, patients with keratoconus presenting for examination at the clinic

Brief summary: Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes.


Eligibility criteria: Inclusion Criteria:

* healthy eyes or eyes with the study conditions

Exclusion Criteria:

* age \< 18, eye disorders other than mentioned above, participation in any other study,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Dept. of Ophthalmology
Study officials:
References:
Clinical trial NCT05913076: Class III Malocclusion and ALT-RAMEC
Official title: Evaluation of the Effects of Alternating Rapid Maxillary Expansion and Facemask Use in Cases of Class III Malocclusion Caused by Maxillary Retrognathia- A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Mask
Rapid Maxillary Expansion
Maxillary Retrognathism
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Diverse viewpoints exist regarding the correlation between the conventional rapid maxillary expansion (RME) and facemask approach and the alternative RME and facemask hybrid technique (Alt-RAMEC) in terms of the degree of maxillary protraction. The findings of the study may offer a novel approach to protocol selection based on the anomaly's degree of severity. The objective of this investigation is to assess and contrast the skeletal and dentoalveolar outcomes of three distinct Alt-RAMEC techniques.

Detailed description: Alternating rapid maxillary expansion and constriction (Alt-RAMEC) procedure is one of the most frequently used methods in the treatment of Class III cases caused by maxillary retrognathia. The objective of this investigation is to conduct a comparative analysis of the skeletal and dentofacial outcomes of three distinct techniques for maxillary protraction Following the primary recording, the patients were evaluated using bonded-type rapid maxillary expansion (RME) devices and three discrete Alt-RAMEC techniques (1, 3, and 5 weeks). Lateral cephalograms were obtained from a sample of 40 patients (18 males and 22 females) with a mean age of 10.64 ± 0.98. These images were taken both before (T1) and after the 6th month of facemask treatment (T2), and were subjected to total and local superimpositions. The Wilcoxon Sign, Kruskal-Wallis and Mann-Whitney U tests were used to evaluate the data.

Eligibility criteria: Inclusion Criteria:

* Maxillary retrognathia (SNA ≤ 79°)
* Skeletal Class III malocclusion (ANB ≤ -1°)
* Anterior cross-bite
* Class III molar relationship
* Horizontal growth pattern (SN/Go-Gn \< 30°)

Exclusion Criteria:

* Previous orthodontic treatment
* Systemic disorders

Primary outcomes:
measure: Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Istanbul University
name: Nilüfer Yılmaz Öğütlü, Dr.
role: STUDY_DIRECTOR
affiliation: Private Practitioner
name: Gülsün Külekçi Çakan
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Hülya Kılıçoğlu, Prof. Dr.
role: STUDY_CHAIR
affiliation: Trakya University
name: Hande Uzunçıbuk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867176: Pain Management in Corneal Collagen Crosslinking for Keratoconus
Official title: Pain Management in Corneal Collagen Crosslinking for Keratoconus: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain scores and variables will be evaluated, along with others side effects variables.

Detailed description: This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to the ketorolac or gabapentin group. The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days. The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days. Different pain scores and variables will be evaluated, along with others side effects variables.

Eligibility criteria: Inclusion Criteria:

* Patients with keratoconus older than 18 years with documented bilateral keratometric progression in the previous 6 to 12 months.

Exclusion Criteria:

* Previous ocular or systemic diseases that could affect epithelial healing; use of topical or systemic non-steroidal anti-inflammatory drugs, or chronic use of any other pain medication, pregnancy and allergy to the drugs of the study.

Primary outcomes:
measure: Numeric scale of pain
timeFrame: 5 days
Secondary outcomes:
measure: Side effects
timeFrame: 5 days
measure: Symptoms related to pain
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Enrique Graue-Hernandez, Md, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT05221476: Red Blood Cell Distribution Width and Charlson Comorbidity Indeces in the Frail Polytraumatized Patient.
Official title: RDW and CCI in the Frail Polytraumatized Patients. A Retrospective Cohort Study in a Level 1 Trauma Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polytrauma
Red Blood Cell Distribution Width
Comorbidities and Coexisting Conditions
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 400
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: Retrospective analysis of polytraumatized patients.

Brief summary: In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. RDW values on admission as well as preexisting comorbidities were evaluated.


Eligibility criteria: Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)

Primary outcomes:
measure: In-hospital mortality in polytraumatized patients
timeFrame: January 2012 to December 2015
Secondary outcomes:
measure: Possible influence of RDW values (%) on admission on the long-term outcome
timeFrame: January 2012 to December 2015
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01867476: Adherence Monitoring For Substance Abuse Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Adherence
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: Creare, Inc.
First posted: 2013-06-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Normals

Brief summary: The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 60
* Ability to give informed consent.
* Be willing and able to use the study-provided phone for taking and transmitting capsule photos.

Exclusion Criteria:

* Unwilling or unable to use a cell phone.
* Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Primary outcomes:
measure: Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval
timeFrame: + 1, 2, 3, 4, 6 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Addiction & Pharmacology Research Lab, St. Luke's Hospital
state: California
Study officials:
affiliation: California Pacific Medical Center
name: John Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995276: PostmenopausAL heaLth And DIseAse (PALLADIA) Study
Official title: PostmenopausAL heaLth And DIseAse (PALLADIA) Study: Prospective Study of the Incidence and Risk Factors of Chronic Diseases Associated With Menopause
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Keywords: menopause
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 4.000 postmenopausal women

Brief summary: This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.


Eligibility criteria: Inclusion Criteria:

Postmenopausal women

Exclusion Criteria:

Men Women of reproductive age

Primary outcomes:
measure: Cardiovascular death
timeFrame: up to 2025
measure: Coronary heart disease
timeFrame: up to 2025
measure: Stroke
timeFrame: up to 2025
Secondary outcomes:
measure: Diabetes mellitus
timeFrame: up to 2025
measure: Osteoporotic fractures
timeFrame: up to 2025
measure: Breast cancer
timeFrame: up to 2025
measure: Any cancer
timeFrame: up to 2025
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Menopause Clinic, Aretaieio Hospital
state: Attica
Study officials:
References: