louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01670747: Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)
Official title: Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS: Acute Respiratory Distress Syndrome
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation

Brief summary: In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
* Mechanical ventilation

Exclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease
* Clinical diagnosis of pneumothorax
* Haemodynamic instability

Primary outcomes:
measure: Computer Tomography (CT) scan lung recruitment and CT lung weight
timeFrame: Study day (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Chiumello Davide, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
citation: Caironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.
citation: Cressoni M, Chiumello D, Algieri I, Brioni M, Chiurazzi C, Colombo A, Colombo A, Crimella F, Guanziroli M, Tomic I, Tonetti T, Luca Vergani G, Carlesso E, Gasparovic V, Gattinoni L. Opening pressures and atelectrauma in acute respiratory distress syndrome. Intensive Care Med. 2017 May;43(5):603-611. doi: 10.1007/s00134-017-4754-8. Epub 2017 Mar 10.
Clinical trial NCT06631677: Expanded Access Program of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab in the Parent Study R5458-668-ALG-2219 (NCT06369467)
Official title: An Open Label, Expanded Access Program of Dupilumab in Adults With Severe IgE-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Food Allergy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-10-08
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program of dupilumab that was never initiated and, therefore, not available.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02974777: The IDEAL-PCI Extended Registry
Official title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Arterioscleroses
Platelet Dysfunction Due to Drugs
Lead sponsor: Kaiser Franz Josef Hospital
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

Detailed description: Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.

In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.

Eligibility criteria: Inclusion Criteria:

* all consecutive PCI patients

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: stent thrombosis
timeFrame: 1 year
measure: bleeding
timeFrame: 1 year
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular Events (MACCE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Kaiser Franz Josef Hospital
Study officials:
affiliation: Kaiser Franz Josef Hospital
name: Guenter Christ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03035383: Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics
Official title: Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: Large thyroid
purse string suture
thyroidectomy
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized controlled study
Primary purpose: TREATMENT

Brief summary: Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed purse-string suture for the first time for the closure of skin defect after thyroidectomy of large thyroid tumors which resulted in better cosmetics as compared to the conventional suturing method.

Detailed description: Increasing demand for better cosmetics following thyroidectomy for large thyroid tumor of \> 6 cm diameter created a necessity to find an alternative to the conventional technique (CT), which could be addressed by purse string technique (PST). A non-randomized controlled trial was conducted to new thyroid tumor patients at Cipto Mangunkusumo Hospital (RSCM) from October 2013 until December 2014. Thirty patients grouped into two intervention arms of thyroidectomy with PST and CT were assessed for post-operative scar outcomes.

Eligibility criteria: Inclusion Criteria:

* New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital
* Tumor diameter \> 6 cm

Exclusion Criteria:

* Previous surgery in the anterior neck area
* Local involvement of lymph nodes requiring nodes dissection

Primary outcomes:
measure: Length of scar
timeFrame: 8 to 12 weeks following thyroidectomy
measure: Width of scar
timeFrame: 8 to 12 weeks following thyroidectomy
measure: Wrinkle
timeFrame: 8 to 12 weeks following thyroidectomy
measure: Patient's satisfaction
timeFrame: 8 to 12 weeks following thyroidectomy
Secondary outcomes:
measure: Duration of surgery
timeFrame: During surgery
measure: Bleeding
timeFrame: During surgery
measure: Post operative hospital stay
timeFrame: 1 week following thyroidectomy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06453083: Medrol Dose Packs for Post-Operative Pain Control
Official title: Prospective Randomized Trial Using Medrol Dose Packs for Post-Operative Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Adolescent Idiopathic Scoliosis (AIS)
Steroid
Medrol
Placebo
Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 57
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.

Detailed description: Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.

Eligibility criteria: Inclusion Criteria:

* age range of 10-21
* received AIS surgery

Exclusion Criteria:

* participants out of the age range 10-21
* other forms of scoliosis (not AIS)

Primary outcomes:
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 2, post (AIS) surgery
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 3, post (AIS) surgery
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 4, post (AIS) surgery
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 5, post (AIS) surgery
measure: Visual Analog Scale (VAS) pain
timeFrame: Day 6, post (AIS) surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Joshua Klatt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191083: Motor Imagery and Action Observation on Motor Learning
Official title: Assessment of the Effects of Motor Imagery and Action Observation on Motor Learning in Healthy Subjects: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Learning
Keywords: Motor imagery
Action observation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2019-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the influence of motor imagery and action observation on motor learning


Eligibility criteria: Inclusion Criteria:

* asymptomatic subjects
* men and women between 18 and 65 years of age
* participants with no systemic, neurological, cognitive or psychological disease.

Exclusion Criteria:

* underage participants
* presence of systemic pathology, pain and/or weakness that prevents the protocol
* participants who have undergone an operation in the spine

Primary outcomes:
measure: The Purdue Pegboard test
timeFrame: Change from hit ratio in a manual skill between baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT00505583: Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy
Official title: A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Methadone-maintenance Subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.


Eligibility criteria: Inclusion:

1. Healthy men or women, aged 18 to 65 years.
2. History of methadone treatment for at least 1 month, at a dose \>=30 and \<=140 mg/day.

Exclusion:

1. History or active presence of clinically important medical disease.
2. Allergy to opioids.

Primary outcomes:
measure: To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT03593083: Acute Excposure of High Altitude on ECG and Non-invasive Blood Pressure.
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High Altitude
Exercise
Electrocardiography
Non-invasive Blood Pressure
Finapres
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments at Low alitude and High altitude
Primary purpose: PREVENTION

Brief summary: Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response of High Altitude (Säntis, 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure High Alitude (2500m above sea level) and low alitude (Zurich) up to 5 hours, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Non-invasive blood pressure (Finapres)
timeFrame: within 5 hours
Secondary outcomes:
measure: Electrocardiography
timeFrame: within 5 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02763683: Investigations of Dementia in Parkinson Disease
Official title: Investigations of Dementia in Parkinson Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinsons
Keywords: Parkinsons Disease
PET Imaging
PIB
VAT
Dementia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institute on Aging (NIA)
First posted: 2016-05-05
Enrollment: 320
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with and without Parkinson disease will be recruited from the Movement Disorders Center at Washington University, the St. Louis metro area, and throughout the midwest region.

Brief summary: The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia.

Detailed description: The purpose of this study is to use a brain imaging method called PIB PET and VAT PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia. The investigators will be including both PD and normal subjects in this study. This a long term study and we are considering including a total of 320 participants in this protocol.

Eligibility criteria: Inclusion Criteria:

* PD patients must exhibit three of the following cardinal signs: rest tremor, rigidity, bradykinesia, or postural instability; or two of these features with one of the first three displaying asymmetry.

Exclusion Criteria:

* history of head trauma, major neurological or psychiatric diseases other than Parkinson disease and dementia, e.g. stroke, multiple sclerosis, depression or schizophrenia.
* severe systemic diseases.
* inability to lie still for 90 minutes.
* metallic implants, pacemakers, or any other contraindication to MRI.
* refusal to consent to brain donation.

Primary outcomes:
measure: Investigations of Dementia in Parkinsons Disease
timeFrame: 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joel S Perlmutter, MD
role: PRINCIPAL_INVESTIGATOR
name: MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242383: Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension
Official title: Morning Hypertension and Monitoring of Metabolism (AWB Morgenhochdruck & Stoffwechselmonitoring)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 13248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with essential hypertension

Brief summary: To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice prescribing conditions with a special emphasis on controlling morning blood pressure


Eligibility criteria: Inclusion Criteria:

- Age ≥ 18 years, insufficiently treated hypertension

Exclusion Criteria:

- Age \< 18 years

Primary outcomes:
measure: Changes in morning blood pressure (BP)
timeFrame: Pre-dose, up to 6 months after start of treatment
measure: Changes in metabolic laboratory parameters
timeFrame: Pre-dose, up to 6 months after start of treatment
measure: Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP
timeFrame: Pre-dose, up to 6 months after start of treatment
measure: Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale
timeFrame: Up to 6 months after start of treatment
measure: Investigator assessment of effects on metabolism on a 3-point rating scale
timeFrame: Up to 6 months after start of treatment
measure: Investigator assessment of tolerability on a 5-point rating scale
timeFrame: Up to 6 months after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 6 months
measure: Changes in morning heart rate
timeFrame: Pre-dose, up to 6 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: