louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691998: Comparison of Different Types of Prosthetic Foott
Official title: Comparison of Different Types of Prosthetic Foot: Patient Perspective
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Previous Prosthetic Foot Experience of Patients With Amputation
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 20 patients with lower limb amputation

Brief summary: The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

Detailed description: One of the main goals in the rehabilitation of amputees is to provide optimal and natural ambulation. For this purpose, suitable socket-suspension type, appropriate knee joint and foot should be prescribed. In the selection of feet, the age, occupation, characteristics of the geographical region, mental status and activity level should be considered. In addition, the previous prosthesis experience of the people should definitely be taken into account during prosthesis prescribing.The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65 years
* Lower limb amputation
* Having used at least 2 different foot types (carbon, hydrolic, microprocessor-controlled)

Exclusion Criteria:

* Having used the single type of foot until now
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Primary outcomes:
measure: Qestion 1
timeFrame: through study completion, an average of one and a half months
measure: Qestion 2
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: dr_yasindemir@yahoo.com
name: Yasin Demir, Associated Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105598: A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
Official title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Dyslipidemia
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
* Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
* Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
* Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight \>50 kg

Exclusion Criteria:

* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \>1.2 x ULN; serum creatinine \>ULN; hemoglobin \<12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
* Use of tobacco or tobacco products
* Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin \>500 mg/day or fish oil which will not have been used for 3 months prior to randomization
* Other exclusion criteria apply

Primary outcomes:
measure: Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
timeFrame: 14 or 28 days
Secondary outcomes:
measure: Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
timeFrame: 14 or 28 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Jim C Khalifa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02202798: New Devices to Measure the Intracuff Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Intubated With a Cuffed Endotracheal Tube
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are being intubated with a cuffed endotracheal tube prior to surgery.

Brief summary: Over the past 5 years, there has been a change in clinical practice with the use of cuffed instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies have recently introduced syringe-like devices to the market which allow the measurement of the intracuff pressure. This study proposes to prospectively compare the intracuff pressure from these devices with the gold standard technique (manometer).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or younger, undergoing a procedure requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria:

* None

Primary outcomes:
measure: Cuff pressure
timeFrame: One time in the OR prior to the start of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03271398: Intensive Therapy Archival Research
Official title: Intensive Therapy Archival Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma, Psychological
Lead sponsor: Trauma Institute & Child Trauma Institute
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants in the Trauma Institute \& Child Trauma Institute Victims of Crime program will be included.

Brief summary: This is an internal treatment evaluation to determine whether eye movement desensitization and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma treatment for the investigator's clients. The investigator is using routine/existing in-house measures and case files to track symptom reduction, trauma treatment time, rate of treatment switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal. This is retrospective as well as prospective archival research.


Eligibility criteria: Inclusion Criteria:

* Victims of crimes, including assault, rape, robbery, intimate partner violence, child abuse, kidnapping, vehicular homicide, and suicide
* Witnesses and family members of victims

Primary outcomes:
measure: Change in TSI-2 following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in TSCC following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in PRS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northampton
country: United States
facility: Trauma Institute & Child Trauma Institute
state: Massachusetts
Study officials:
affiliation: Trauma Institute & Child Trauma Institute
name: Ricky Greenwald, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenwald R, Camden AA. A pragmatic randomized comparison of intensive EMDR and intensive PC for victims of crime. Psychol Trauma. 2024 Jan;16(1):134-142. doi: 10.1037/tra0001176. Epub 2022 Feb 10.
Clinical trial NCT00623298: Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy
Official title: Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy -A Controlled Clinical Trial With Orphaned Survivors of the Rwandan Genocide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Depression
Narrative Exposure Therapy
Interpersonal Psychotherapy
Keywords: Posttraumatic stress disorder
depression
Narrative Exposure Therapy
Interpersonal Psychotherapy
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: vivo
First posted: 2008-02-26
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.

Detailed description: The 1994 genocide of Rwanda has left countless children orphaned. 26 Rwandan orphans who fulfilled DSM-IV diagnosis of PTSD were offered participation in a controlled treatment trial. A group adaptation of Interpersonal Psychotherapy (IPT, n = 14) was compared to Narrative Exposure Therapy (NET, n = 12). Main outcome measures were symptoms of PTSD and depression assessed pre-treatment, 3 months after therapy (post-test) and 6 months after therapy (follow-up) using the CAPS, MINI and Hamilton Rating Scale. At post-test, participants in both treatment conditions showed reductions in posttraumatic stress symptoms and depression symptoms. At 6-month follow-up, NET proved to be more effective in the treatment of PTSD. Only 25% (n = 3) of NET-participants but 71% (n = 10) of the IPT-participants still fulfilled PTSD criteria at follow-up. Although there was a significant reduction in depression symptoms in both treatment groups from pre-test to follow-up, NET again proved to be more effective. This treatment-trial demonstrates that NET and group-IPT are suitable treatment modules even when most severe traumatic stress and difficult living conditions have led to chronic mental suffering.

Eligibility criteria: Inclusion Criteria:

* Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide

Exclusion Criteria:

* Mental retardation
* Psychotic symptoms or current drug or alcohol

Primary outcomes:
measure: Symptoms of posttraumatic stress disorder, symptoms of depression
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04724798: Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO
Official title: Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracorporeal Membrane Oxygenation
Pharmacokinetics
Tigecycline
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.

Brief summary: Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.


Eligibility criteria: Inclusion Criteria:

* critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.

Exclusion Criteria:

* People who had taken tigecycline in the past week
* People who were pregnant
* People who had coagulation dysfunction

Primary outcomes:
measure: Serum drug concentration of tigecycline
timeFrame: predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university Nanfang hospital
Study officials:
References:
Clinical trial NCT02789098: Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction
Official title: Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: ST Elevation Myocardial Infarction
Ventricular remodeling
Biomarkers
Coronary endothelial function
Positron Emission Tomography
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Société Française de Cardiologie
First posted: 2016-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.


Eligibility criteria: Inclusion Criteria:

* First ST Elevation Myocardial Infarction
* Primary Percutaneous Coronary Intervention (TIMI 3)
* Single vessel coronary artery disease
* Age over 18 years
* Informed Consent dated and signed
* Written and spoken French
* Beneficiary of social security insurance

Exclusion Criteria:

* No Primary Percutaneous Coronary Intervention
* TIMI 0-2 after Primary Percutaneous Coronary Intervention
* Significant two or three-vessel coronary artery disease (\> 70% stenosis in at least one of the other two coronary arteries)
* Past history of myocardial infarction before STEMI
* Mechanical complication (ischaemic mitral regurgitation, interventricular septal defect, cardiac tamponade) or clinical signs of heart failure
* Pregnant and / or lactating
* Age under 18 years or guardianship

Primary outcomes:
measure: Measurement of coronary endothelial function
timeFrame: 3 months
measure: Measurement of fibrosis
timeFrame: 3 months
Secondary outcomes:
measure: Correlating biomarkers with local and global parameters of coronary endothelial function , inflammation and myocardial fibrosis with early echocardiographic parameters of left ventricular remodeling and cardiac magnetic resonance imaging
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHu de Caen
state: Normandie
Study officials:
affiliation: CHU CAEN
name: Farzin GF BEYGUI, PhD
role: STUDY_CHAIR
affiliation: CHU CAEN
name: Alain MA Manrique, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05437198: Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD
Official title: Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with chronic obstructive pulmonary disease (COPD) and no-COPD control subjects

Brief summary: COPD and non-COPD patients will be included in the study after collection of their non-objection. The exhalation will be collected to study the microbiological diversity of human exhalations.

a second collection for the year +1 will be made, at the same time (between October and March).

Detailed description: The subjects will be recruited during a medical visit in the Departments of Pneumology and Occupational and Environmental Pathologies.

After information and inclusion of the subject in the study, a collection of clinical data, the state of health and the smoking status of the subject will be carried out by the clinical study technician.

A collection of the exhalation will also be carried out by the clinical study technician.

Several groups of subjects will be formed according to pathologies (COPD versus non-COPD), age and smoking status

Eligibility criteria: Inclusion Criteria:

For COPD:

* Patients with chronic obstructive pulmonary disease
* Age: over 18

For non-COPD

* Absence of chronic obstructive pulmonary disease
* Age: between 18 and 30 years old and between 45 and 70 years old

Exclusion Criteria:

* Taking certain medications in the month preceding the sample (antibiotics, systemic corticosteroids, immunosuppressants)
* Person under guardianship or curatorship
* Pregnant or breastfeeding women
* Person unable to express his/her opposition, person deprived of liberty
* Existence of a chronic infectious pulmonary pathology such as (dilation of the bronchi, cystic fibrosis)

Primary outcomes:
measure: Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects
timeFrame: Baseline
Secondary outcomes:
measure: Number and dominant bacterial species in human exhalations according to smoking status
timeFrame: Baseline
measure: Number and dominant bacterial species in human exhalations according to age
timeFrame: Baseline
measure: Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season
timeFrame: 1 year
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
Study officials:
affiliation: CHI créteil
name: Jean Claude PAIRON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03878498: Management of Anal Fistula of Crohn Disease
Official title: Management of Anal Fistula of Crohn Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Fistula
Crohn Disease
Keywords: Crohn disease
anal fistula
anal surgery
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anal fistula in Crohn Disease and needed fistula drainage or surgery

Brief summary: The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

Detailed description: Patients with anal fistula with Crohn disease and needed anal fistula drainage will be included. Medical and surgical treatments will be recorded. The management will be described and the best approaches will be identified.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Crohn's disease with fistulizing anoperineal lesion
* Operated at least once for this reason

Exclusion Criteria:

* Adult person protected under the Public Health Code
* Minor person

Primary outcomes:
measure: Description of the therapeutic management of anal fistula in Crohn Disease
timeFrame: The inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Charlène BROCHARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01719198: Usefulness of Calprotectin for Colon Adenoma Screening
Official title: Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Adenoma
Keywords: adenoma
calprotectin
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who visit KUH healthcare center for colonoscopy in Korea over 18 years old adult population

Brief summary: The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.


Eligibility criteria: Inclusion Criteria:

* over 18 years old adult population

Exclusion Criteria:

* none

Primary outcomes:
measure: fecal calprotectin level
timeFrame: 1 day (at the hospital visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University
name: Yeo-Min Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: