louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03367169: Surgery of the Pilon Fractures
Official title: Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pilon Fractures
Fractures
Bone
Leg Injuries
Keywords: Pilon fractures
Osteosynthesis
Mini invasive plate osteosynthesis
Locked plate
Open reduction
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.

The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

Detailed description: Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method.

Investigators think that the minimally invasive method with intern plate is more efficient than the open reduction method.

These techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment.

The minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions.

It's all these issues investigators would like to assess with a randomized study.

Eligibility criteria: Inclusion Criteria:

* More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
* signed patient consent

Exclusion Criteria:

* Open pilon fracture cauchoix type 2 or 3,
* infection of the operating site,
* previous osseous disease
* patient who are unwilling or unable to give consent

Primary outcomes:
measure: Healing
timeFrame: at 45 days
Secondary outcomes:
measure: AOFAS clinical score
timeFrame: pre op, 45 days, 3, 6 and 12 months
measure: Nach mazur and al score
timeFrame: pre op 45 days, 3, 6 and 12 months
measure: The Foot & Ankle Disability Index
timeFrame: pre op 45 days, 3, 6 and 12 months
measure: Pain
timeFrame: pre op 45 days, 3, 6 and 12 months
measure: Complications
timeFrame: pre op 45 days, 3, 6 and 12 months
measure: Radiologic evaluation
timeFrame: pre op 45 days, 3, 6 and 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Roger ERIVAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06870669: The Effect of Progressive Relaxation Exercises by Nursing Students Before Clinical Practice
Official title: The Effect of Progressive Relaxation Exercises Applied to First Year Nursing Students Before Clinical Practice on Perceived Stress, Psychological Resilience and Meaning of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Stress
Exercise
Keywords: Progressive Relaxation Exercises
Nursing
Students
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: We conducted this randomized controlled study to determine the effect of Progressive Relaxation Exercises practiced by first year nursing students before clinical practice on their perceptions of stress, psychological resilience and meaning of life.

Background: Progressive Relaxation Exercises has a positive effect on the person's mental/general health, life satisfaction and psychological well-being and enables the person to cope with stress.

Design: In this experimental randomized and controlled study including a control group, we administered a pre-test, post-test one and post-test two to the participating students.

Methods: We are planning the study with 40 first year nursing students in the intervention group, and 40 first year nursing students in the control group. The students in the intervention group took part in eight sessions of Progressive Relaxation Exercises for four weeks, twice a week. We used the Student Introduction Form, Perceived Stress Scale, Brief Psychological Resilience Scale and Meaning and Purpose of Life Scale to collect the study data.


Eligibility criteria: Inclusion Criteria:

Who did not have any diagnosed psychiatric diseases, Who had not done Progressive Relaxation Exercises and / or did not have any clinical experience previously were included

Exclusion Criteria:

Who withdrew from the study at any stage, Those who did not participate in the exercise sessions regularly Those who used another relaxation method during this period, Those who took antidepressants, Those who were unwilling to participate in the study, Those who lost one of their loved ones in the last 6 months were excluded from the research.

Primary outcomes:
measure: Stress
timeFrame: four weeks
measure: psychological resilience
timeFrame: four weeks
measure: Meaning and Purpose of Life
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
state: Yunusemre
Study officials:
References:
Clinical trial NCT05053269: Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Official title: Association of Body Weight Growth After Birth and Bronchopulmonary Dysplasia(BPD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bronchopulmonary Dysplasia
Preterm
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the preterm infants' gestational age is equal to or less than 32 weeks will be included in the study

Brief summary: Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.

Detailed description: Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.

The aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.

Eligibility criteria: Inclusion Criteria:

* equal to or less than 32 weeks' gestational age

Exclusion Criteria:

* main congenital malformation
* parents' refusal

Primary outcomes:
measure: the incidence of BPD
timeFrame: up to 36 weeks' gestational age
Secondary outcomes:
measure: body weight growth after birth
timeFrame: up to 36 weeks' gestational age
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT03696069: A Study is to Understand the Treatment Patterns for Immunotherapy Agents and BRAF/MEK Inhibitors Used in the Treatment of Advanced Melanoma
Official title: Understanding the Treatment Patterns, Healthcare Resource Utilization, Costs of Care, and Clinical Outcomes Among Patients Treated for Advanced Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced melanoma treated with immunotherapy and BRAF/MEK inhibitors

Brief summary: The goal of the study is to understand the treatment patterns for immunotherapy agents and BRAF/MEK inhibitors used in the treatment of advanced melanoma


Eligibility criteria: Inclusion Criteria:

* Patients must have ≥1 medical or pharmacy claim for nivolumab, ipilimumab, pembrolizumab, nivolumab+ipilimumab (on the same day), dabrafenib, vemurafenib, cobimetinib, trametinib, dabrafenib+trametinib (on the same day) and vemurafenib+cobimetinib (on the same day)
* Patients must have ≥6 months of continuous health plan enrollment prior to index date
* Patients must have ≥2 medical claims at least 30 days apart with a diagnosis for melanoma during the study period AND ≥1 diagnosis for melanoma during the baseline period prior to or on the index date

Exclusion Criteria:

* Patients with ≥1 claim for the agents of interest including immunotherapy agents and BRAF/MEK inhibitors between the first diagnosis of metastatic disease and the day prior to the index date will be excluded
* Patients with a claim for acquired immunodeficiency virus (AIDS) anytime during the study period
* Patients under the age of 18 as of index date

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Treatment free interval (TFI)
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Overall survival rate
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01881269: Respiration Rate Monitoring During Transitions
Official title: Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of the Study is Measuring Respiratory Rate
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer subjects from a hospital population, who are scheduled to undergo surgery requiring general anesthesia

Brief summary: The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.


Eligibility criteria: Inclusion Criteria:

* Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
* American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
* Body mass index (BMI) ≤30 kg/m2.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
* Female subjects who are currently lactating and breastfeeding.
* Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
* Subject has an abnormality that may prevent proper application of the device/sensors.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subjects with non-sinus rhythm, frequent premature ventricular complexes (\> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
* Subjects with artificial finger nails.

Primary outcomes:
measure: Time to report a Respiration Rate value after initiation of controlled ventilation
timeFrame: 1 - 3 minutes after the initiation of controlled ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Lumbley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01990469: Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 219
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Detailed description: Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Eligibility criteria: Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus
2. Adults aged ≥ 19 years old
3. Patients with HbA1c 7%\~11% at Visit 1

Primary outcomes:
measure: Change of HbAlc from baseline at Week 24
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06735469: Clinical Trial Preference Study
Official title: Leveraging Discrete Choice Experiments to Increase Participant Diversity in Future Clinical Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Trials
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: United States adults

Brief summary: Population subgroups experiencing health disparities are often also underrepresented in clinical trials. These groups include individuals from minoritized racial and ethnic groups, people from lower socioeconomic backgrounds, and men or women, depending on the study area. Identifying approaches to reduce health disparities will remain stalled until clinical trials can recruit and retain diverse clinical trial participants. To improve recruitment across studies, there is a need to understand how diverse populations view specific clinical trial attributes that could be manipulated to increase interest in trials. To address this need, this project will use a discrete choice experiment to identify and prioritize specific trial attributes under investigators' control that could be leveraged to enhance clinical trial participation rates in underrepresented groups. This project will evaluate participants' preferences of 1) return of full versus limited results to participants, 2) balancing a study's participant burden with its ability to address multiple research aims, 3) incentivizing clinical assessments vs. conducting homebased assessments, and 4) results generalizable to specific social groups versus the broader population. This experiment will be conducted with a sample of potential clinical trial participants (N = 800) that is diverse in terms of self-reported gender, racial and ethnic identity, education, and chronic disease status. The results of this study will be used to design a randomized comparison of enhanced clinical trial attributes across multiple health conditions to evaluate whether using the enhanced trial features can more efficiently recruit underrepresented participants into clinical trials.


Eligibility criteria: Inclusion Criteria:

* Internet access with audio and visual capabilities
* Reside within the United States
* Read and speak English

Exclusion Criteria:

* Under 18 years of age
* No internet access
* Reside outside of the United States
* Do not read and speak English

Primary outcomes:
measure: Participant preference for clinical trial attributes
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT01645969: A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265
Official title: A Follow-up Study to Evaluate the One-year Post Treatment Effects of Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study ML 22265
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received treatment and completed follow-up in study arm "A" of study ML22265

Brief summary: This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.


Eligibility criteria: Inclusion Criteria:

* Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point

Exclusion Criteria:

* Patients unwilling to provide informed consent or abide by the requirements of the study

Primary outcomes:
measure: Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
city: Fu Zhou
country: China
city: Guangzhou
country: China
city: Wuhan
country: China
city: Xi'an
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04801069: Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
Official title: Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Sleep Apnea Syndromes
Lead sponsor: SOS Attaque Cérébrale
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.


Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke on brain MRI
* NIHSS 6-22
* thrombolysis

Exclusion Criteria:

* Previous SAS
* Previous stroke
* Auto-adaptative Servo-Ventilation Contraindication

Primary outcomes:
measure: Infarct progression
timeFrame: 7 days
Secondary outcomes:
measure: Neurological outcome
timeFrame: 3 months
measure: Neurological outcome on NIHSS
timeFrame: 3 months
measure: Duration of Auto-adaptative Servo-Ventilation use
timeFrame: 7 days
measure: SAS prevalence
timeFrame: 3 months
measure: SAS severity
timeFrame: 3 months
measure: Central apnea index
timeFrame: 3 months
measure: Obstructive apnea index
timeFrame: 3 months
measure: Quality of life on SF-12 questionnaire
timeFrame: 3 months
measure: Quality of sleep on Pittsburgh Sleep Quality Index
timeFrame: 3 months
measure: Daytime Sleepiness
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Meseguer
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Elena Meseguer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05623969: Markers of Atrial Cardiopathay
Official title: Markers of Atrial Cardiopathay
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Cardiopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Patients complaining of palpitation referred for Holter monitoring

Brief summary: Marker of atrial cardiopathay as apredictor value of ischemic stroke

Detailed description: detection of the presence of atrial dysfunction or atrial cardiopathy and its degree among patients complaining of palpitation, with a one-year follow-up for any cardioembolic events (stroke /TIA).

Eligibility criteria: Inclusion Criteria:

* Patients complaining of palpitation referred for Holter monitoring

Exclusion Criteria:

* • Valvular AF, moderate to severe mitral/ tricuspid/ aortic stenosis or regurgitation.

  * Recent myocardial infarction within 3 months.
  * Acute pulmonary embolism.
  * Newly onset AF during or shortly after cardiac surgery.
  * Specific type of cardiomyopathy such as cardiac amyloidosis, obstructive hypertrophic cardiomyopathy.

Decompensation stage of organ failure

Primary outcomes:
measure: Detection of any underlying arrythmia after holter monitoring for twenty four hours
timeFrame: Detection of any underlying arrythmia after holter monitoring for twenty four hours
Secondary outcomes:
measure: Detection of atrial dysfunction or atrial cardiopathy and its degree among patients complaining of palpitation, with 6 month follow-up for any cardioembolic events (stroke /TIA).
timeFrame: Detection of atrial dysfunction or atrial cardiopathy and its degree among patients complaining of palpitation, with 6 month follow-up for any cardioembolic events (stroke /TIA).
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mariam zarief farhan
Study officials:
affiliation: Assiut University
name: Mohammed Aboelkassem Farghal, professor
role: PRINCIPAL_INVESTIGATOR
References: