louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03405038: Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization
Official title: Prone Position Impact in Patients With Acute Respiratory Distress Syndrome on the Incidence of Central Venous Catheter Colonizations in Reanimation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Catheter Infection
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS patients with a central venous catheter placed or not into prone position

Brief summary: Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.

Detailed description: Catheter-associated infection prevention is achieved by identification of the population at risk. Patients receiving prone position Under acute respiratory distress syndrome appear to be particularly vulnerable. This retrospective study is designed to compare the risk of catheter colonization that could be induced or worsened by prone position. Knowing that, prone position is increased into the care acute respiratory distress syndrome since few years. Unfortunately, no study has examined the prone position impact on catheter-association infection in these population.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
* Patient with an acute respiratory distress syndrome, moderate or severe
* With a central venous catheter
* With or without prone position during the stay

Exclusion Criteria:

* Minor patient
* Absence of information on central venous catheter bacteriology

Primary outcomes:
measure: Impact of the prone position
timeFrame: Day 1
Secondary outcomes:
measure: Infection associated factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
Study officials:
References:
Clinical trial NCT04365738: Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection
Official title: Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Pulmonary Rehabilitation
Dyspnea
Fatigue
Pain
Anxiety
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 270
Sex: ALL
Minimum age (years): 28
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

Detailed description: This study was conducted with 270 patients who were the COVID-19 test was positive and isolated in their homes during post-acute periods.While one of the groups (n=135) was asked to remain isolated at home by providing patient education,a PR program was applied for 4 weeks in addition to the patients in the other group(n=135).PR consists of patient education, breathing, in-house mobilization and range of motion exercises.As the evaluation parameters,pre-treatment and post-treatment dyspnea levels with Borg scale,muscle pain with visual analog scale(VAS),functional capacities with sit-up test,chest expansions with tape measure,respiratory frequency,fatigue level with fatigue severity scale,and emotional status with hospital anxiety and depression(HAD) scale were evaluated.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 28-45, positive COVID-19 test, being in the post-acute period, having symptoms of mild-moderate severity, respiratory rate ≤40 breaths / min, patients who can make video speech

Exclusion Criteria:

* Severe symptom involvement, fever more than 38 degrees, obese patients, patients with multiple comorbidities, patients with one or more organ failure, oxygen saturation in the blood ≤95%, a resting blood pressure of \<90/60 mmHg or\> 140 / 90 mmHg patients

Primary outcomes:
measure: Dyspnea
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
measure: Chest expansion
timeFrame: Baseline, up to 4 weeks
measure: Fatigue severity
timeFrame: Baseline, up to 4 weeks
measure: Visual Analog Scale for pain
timeFrame: Baseline, up to 4 weeks
measure: Hospital anxiety and depression scale
timeFrame: Baseline, up to 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
Study officials:
affiliation: Istanbul Bilgi University
name: Tomri̇s Duymaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00100438: Incidence of Parkinson's Disease Among Veterans
Official title: Incidence of Parkinson's Disease Among Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2004-12-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a database study. Medical records will be reviewed in order to document a new or pending diagnosis of Parkinson's disease and in order to learn more about the disease process. Other than the time that it takes to complete a medical record authorization form, no other human subject participation will be needed.


Eligibility criteria: chart review

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Veterans Affairs Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT06167538: Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients
Official title: Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Injuries
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 60
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 adult SABI patients ≥ 18 years with a tracheal tube at admission to the Department of Brain Injury from September 2021 to October 2022 and treated with the new decannulation procedure will be included. Patients with SABI and a tracheal tube in whom decannulation was attempted between July 2019 until December 2020 will serve as a historical control group.

Brief summary: After severe acquired brain injury (SABI: severe traumatic brain injury, stroke, anoxic brain damage), up to 50-70% of patients are tracheostomized. The need to tracheostomize a patient is based on the prolonged inability to breathe and/or protect their airway sufficiently. This is usually done in an Intensive Care Unit (ICU). A tracheostomy is first removed when the patient's clinical conditions allow for it. The removal can be performed in many settings, a neurological rehabilitation unit being one of these.

The overall objective of this study is to evaluate the safety of this earlier decannulation procedure in patients with SABI at our department as well as the effectiveness on functional ability.


Eligibility criteria: Inclusion Criteria:

All severe acquired brain injury patients ≥ 18 years with a tracheal tube at admission.

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality at three months after hospital discharge
timeFrame: Three months counted from hospital discharge
measure: Mortality at twelve months after hospital discharge
timeFrame: Twelve months counted from hospital discharge
Secondary outcomes:
measure: Rate of antibiotics prescribed to treat pneumonia after decannulation
timeFrame: Counted number of days from decannulation until discharge
measure: Rate of re-cannulation of the tracheal tube after initial decannulation
timeFrame: Counted number of days from decannulation until discharge
measure: Length of hospital stay
timeFrame: Counted number of days from admission to our department until discharge
measure: Rate of hospital readmission at two and twelve months after discharge
timeFrame: At two and twelve months respectively counted from discharge
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Brain Injury, Rigshospitalet
Study officials:
References:
Clinical trial NCT00178438: Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
Official title: A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Keywords: capsule endoscopy in small bowel
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.

Detailed description: Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.

Eligibility criteria: Inclusion Criteria:

* English speaking adult patients (\>18 years old) with known Crohn's disease

Exclusion Criteria:

* Severe medical or psychiatric co-morbidities
* Active swallowing problems
* Bowel obstruction
* History of stricture or fistula
* Pregnancy
* Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy
* Inability to consent
* Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease

Primary outcomes:
measure: Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
Secondary outcomes:
measure: Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester Medical Center, Digestive and Liver Disease Unit
name: Parvez S Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03939338: Combination With Treg Levels and CMR to Assess the Severity and Prognosis of Reperfusion Injury After PPCI in STEMI Patients
Official title: Combination With Regulatory T Cell Levels and Cardiac Magnetic Resonance Imaging (CMR) to Assess the Severity and Prognosis of Reperfusion Injury After Primary PCI in STEMI Patients (TregCMRRS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Reperfusion Injury, Myocardial
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 250
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: Patients admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention

Brief summary: This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).


Eligibility criteria: Inclusion Criteria:

* Confirmed STEMI diagnosis
* Undergoing primary percutaneous coronary intervention (presenting \<12 hours after symptom onset)
* Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
* Patients agreed and provided informed consent

Exclusion Criteria:

* Previous myocardial infarction or revascularization (PCI or CABG)
* Congestive heart failure with LVEF\<40%
* Atrial fibrillation
* Renal insufficiency (GFR \< 30 ml/min/1.73m\^2)
* Acute infectious diseases within nearly 3 months
* Rheumatic immune system diseases
* Malignant tumors
* Claustrophobia
* Contraindicated to CMR
* Patients do not agree to be included in the study

Primary outcomes:
measure: MACE (major adverse cardiovascular events)
timeFrame: 12 months
Secondary outcomes:
measure: adverse cardiac remodeling
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06370338: Cardiothoracic Critical Care as Subspecialty and Its Core Competencies
Official title: Delphi Study for Evaluation of Cardiothoracic Critical Care as a Subspecialty and Its Core Competencies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Consensus Development
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 68
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: A team of experts in the field of cardiothoracic critical care anesthesia.

Brief summary: The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field.

Detailed description: This study will use the Delphi process to conduct this study. This survey research involves Phase 1 and Phase 2 of questioning, each phase involves up to 3 rounds of questions to determine agreement or disagreement. Each round will take approximately 20 minutes to complete, and responses will remain completely confidential. For both phases, the questions will either be 7-point Likert or multiple choices. For both phases, the group of questions will be sent up to three times until agreement (up to 80% of agreement consensus). Questions that have obtained agreement will be removed in each round. The questions will help the experts and the research team understand where there is current agreement on, or topic that may need to be discussed/studied further to unify trainings.

Eligibility criteria: Inclusion Criteria:

* The participants will be experts in the field of Cardiothoracic Surgery Critical Care Medicine to better understand the training needs of the field. Experts must have been in practice for a minimum of 5 years and have at least 50% of practice in cardiothoracic intensive care units.
* The participants will have graduated from a critical care fellowship in either an administration, education, or research role.

Exclusion Criteria:

* Participants who do not meet the exclusion criteria will be excluded due to their lack of experience in the field.

Primary outcomes:
measure: Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field
timeFrame: 12 months
Secondary outcomes:
measure: Degree of consensus on defining training core competencies, goals, and milestones.
timeFrame: 12 months
measure: Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality"
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT04736238: Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy
Official title: Peking University People's Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Talofibular Ligament Injury
Ankle Sprains
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study mainly evaluated the clinical effect of total arthroscopic repair of the anterior talofibular ligament in the treatment of chronic instability of the lateral ankle. For patients with chronic instability of the lateral ankle, a randomized controlled trial was used to compare the curative effect, operation time, surgical complications, postoperative recurrence rate, postoperative recovery time and patients' satisfaction of the total arthroscopic repair of the anterior talofibular ligament surgery and the modified BrostrÖm surgery.


Eligibility criteria: Inclusion Criteria:

1. A history of acute lateral ankle sprain.
2. The patient has chronic instability of the lateral ankle joint, including functional instability or mechanical instability; functional instability refers to the patient's subjective ankle joint looseness or instability; mechanical instability refers to the presence of the ankle joint History of repeated sprains, positive examination of the front drawer test or positive X-ray examination of the stress position (inversion stress, anterior axial stress).
3. The ankle MRI suggested the anterior talofibular ligament injury.
4. It is invalid after 3 months of formal conservative treatment.

Exclusion Criteria:

1. Co-infection.
2. There was a previous ankle fracture in the affected limb.
3. The affected limb has previously undergone foot and ankle surgery.
4. Ankle inverted arthritis or Charcot joint disease.
5. Suffer from mental illness.

Primary outcomes:
measure: AOFAS ankle-hindfoot score
timeFrame: At 12 months after surgery
Secondary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: At 12 months after surgery
measure: SF-36 Quality of Life Scale
timeFrame: At 12 months after surgery
measure: Complications
timeFrame: At 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
Clinical trial NCT06110338: Safety and Tolerance Study of IBI355 in Health Volunteers
Official title: A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
2. Healthy male and female aged 18 years or above ;
3. Subject with a Body Mass Index (BMI)\* between 18.5 and 28.0 kg/㎡;
4. subjects with a normal laboratory examination，ECG， X-ray.

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Primary outcomes:
measure: Incidence of AE、SAE after receiving IBI 355
timeFrame: week 0-12
Secondary outcomes:
measure: Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355
timeFrame: week 0-12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
Study officials:
References: