louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02018939: Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
Official title: Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections During Organ Replacement Therapy
Keywords: pharmacokinetics, doripenem, renal replacement therapy, MARS, organ replacement therapy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Organ replacement therapy (MARS, CVVHDF or HD)

Exclusion Criteria:

* Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
* An expected survival of less than two days.
* Known pregnancy
* Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
* Doripenem as monotherapy for resistent species or fungal infections.
* Other reasons opposing the study participation on the discretion of the investigators.

Primary outcomes:
measure: Influence of organ replacement therapy on area under curve of doripenem serum concentration
timeFrame: day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Vossen MG, Ehmann L, Pferschy S, Maier-Salamon A, Haidinger M, Weiser C, Wenisch JM, Saria K, Kajahn C, Jilch S, Lemmerer R, Becede M, Zeitlinger M, Kloft C, Jager W, Thalhammer F. Elimination of Doripenem during Dialysis and Pharmacokinetic Evaluation of Posthemodialysis Dosing for Patients Undergoing Intermittent Renal Replacement Therapy. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02430-17. doi: 10.1128/AAC.02430-17. Print 2018 May.
citation: Vossen MG, Wenisch JM, Maier-Salamon A, Fritsch A, Saria K, Zuba C, Jilch S, Lemmerer R, Unger M, Jaehde U, Jager W, Thalhammer F. Doripenem Treatment during Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1687-94. doi: 10.1128/AAC.01801-15.
Clinical trial NCT01843439: Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Aged
Keywords: Acute exacerbation
Quality of life
Magnesium deficiency
Multidisciplinary intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2013-04-30
Enrollment: 360
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma.

In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics.

We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts.

So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct.

1. popularize and educate the asthma action plan
2. run a emergency call system for acute exacerbation
3. educate the proper techniques using inhalers
4. correct the deficiency of magnesium (magnesium 500 mg per day)

After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.


Eligibility criteria: Inclusion Criteria:

* elderly asthma patients who had experienced acute exacerbation of asthma

  1)aggravations of any of major criteria
* dyspnea
* cough
* wheezing
* increase or purulent changes of sputum
* nocturnal symptoms

  2)aggravation of more than one of following criteria
* a reduction of forced expiratory volume at one second or peak expiratory flow rate more than 20% compared than one's best score
* unscheduled clinic or emergency department visit or admission
* step-up of dose of asthma medications or any intake of systemic steroids

Primary outcomes:
measure: Number of acute exacerbation of asthma
timeFrame: 1 year from enrollment
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 1 year after enrollment
measure: Asthma control status
timeFrame: one year from enrollment
measure: asthma quality of life questionnaire
timeFrame: one year from enrollment
measure: serum magnesium level
timeFrame: one year from enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang-Heon Cho, MD./PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01102439: Clopidogrel/Aspirin Interaction Study
Official title: Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
Aspirin
Interaction
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

Detailed description: Study Hypothesis: Patients receiving double-dose compared with standard-dose clopidogrel will have increased blood concentrations of the active metabolite of clopidogrel and greater inhibition of ADP-induced platelet aggregation when also treated with acetylsalicylic acid (ASA) 325 mg/d as compared to ASA 81 mg/d.

Eligibility criteria: Inclusion Criteria:

* \> 1 month post myocardial infarction (MI), unstable angina or stent patients with stable condition
* Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
* Written informed consent

Exclusion Criteria:

* Age \< 18 years old
* Liver disease with transaminases and/or bilirubin \> 1.5x upper limits of normal (ULN) (within 3 months of randomization)
* Renal impairment with creatinine clearance \< 30 ml/min (within 3 months of randomization)
* Platelet count \< 100x109/L and/or Hb\< 100g/L (within 3 months of randomization)
* Use of oral anticoagulants or nonsteroidal antiinflammatory drug (NSAID) within the last 10 days or planned use during the study
* Use of antiplatelet agent other than aspirin and clopidogrel within the last 10 days
* High risk of bleeding (e.g. recent gastrointestinal bleeding, bleeding diathesis)
* Uncontrolled hypertension (\> 180/110mmHg)
* Current smoker with ≥ 5 cigarettes/day
* Previously entered in this study or just finished other study within 2 weeks before recruitment
* Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent

Primary outcomes:
measure: Blood concentrations of the active metabolite of clopidogrel
timeFrame: 14 days
Secondary outcomes:
measure: Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
timeFrame: 14 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Population Health Research Institute
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Yan Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: John Eikelboom, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03055039: Epidemiology of Pain in the Delivery Room
Official title: Epidemiology of New Born Child Pain in the Delivery Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Born Child Pain
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room

Brief summary: The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy. During the delivery the baby is exposed to multiple exterior factors and he is capable to memorize the pain .Recent epidemiologic studies showed that the coverage of pain was insuffcient and also an increase of analgesic means. Normally the pain coverage have to be managed and group every painful gesture. In fact all these recommandations are not followed by medical team.

The aim of the study is to evaluate the prevalence of this type of pain as to set up an adequate coverage.


Eligibility criteria: Inclusion Criteria:

* Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room

Exclusion Criteria:

* Newborn child been born in palliative care
* non francophone parents

Primary outcomes:
measure: Evaluation of prevalence of the newborn child 's pain in delivery room
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT02801539: Respiratory Muscle Training in L-Onset Pompe Disease (LOPD)
Official title: Respiratory Muscle Training in Late-Onset Pompe Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycogen Storage Disease Type II
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-06-16
Enrollment: 22
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 study is being done to test the effects of respiratory muscle training (RMT) in patients with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles. The results of this study will help design future research studies about RMT in LOPD. The goals of this study are to decide if sham-RMT is a useful control condition for RMT and to choose the best ways to measure the health benefits of RMT in LOPD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of LOPD
* On enzyme replacement therapy for ≥ 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based RMT regimen

Exclusion Criteria:

* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Inability to give legally effective consent
* Inability to read and understand English

Primary outcomes:
measure: Change in respiratory strength
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Feasibility of sham-RMT, as measured by program adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in maximum expiratory pressures (MEP)
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Change in 6-minute walk test (6MWT)
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Change in Gait, Stairs, Gower, and Chair (GSGC) scale
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Change in peak cough flow (PCF)
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Change in Rasch-built Pompe-specific Activity Score (R-PAct)
timeFrame: baseline, 12 weeks, 6 months, 9 months
measure: Change in diaphragm thickness
timeFrame: baseline, 12 weeks, 6 months, 9 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Division of Head and Neck Surgery & Communication Sciences, Duke University
name: Harrison Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones HN, Kuchibhatla M, Crisp KD, Hobson Webb LD, Case L, Batten MT, Marcus JA, Kravitz RM, Kishnani PS. Respiratory muscle training (RMT) in late-onset Pompe disease (LOPD): A protocol for a sham-controlled clinical trial. Mol Genet Metab. 2019 Aug;127(4):346-354. doi: 10.1016/j.ymgme.2019.05.001. Epub 2019 May 8.
Clinical trial NCT05309239: ROX Index in Acute Respiratory Failure
Official title: Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rox Index
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients administered in chest ICU in Assiut university hospital

Brief summary: evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation


Eligibility criteria: Inclusion Criteria:

* Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :

  1. PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min
  2. Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration

Exclusion Criteria:

* 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.

  2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.

  3. Resusal to participate in the study

Primary outcomes:
measure: Success vs failure of non invasive ventilation
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00916539: Cast Immobilization for Non-Displaced Scaphoid Fractures
Official title: Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-displaced Scaphoid Fractures
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 62
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: This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Isolated fracture of the scaphoid
3. No displacement of the scaphoid fracture on CT scan

Exclusion Criteria:

1. Associated ipsilateral ligament injury or fracture
2. Pregnant Patient

Primary outcomes:
measure: Extent of Union
timeFrame: 10 weeks
Secondary outcomes:
measure: DASH Questionnaire
timeFrame: 6 months
measure: Modified Mayo Wrist Score
timeFrame: 6 months
measure: Grip Strength
timeFrame: 6 months
measure: Visual Analog Scale for Pain
timeFrame: 6 months
measure: Range of Motion: Flexion
timeFrame: 6 months
measure: Range of Motion: Extension
timeFrame: 6 months
measure: Range of Motion: Ulnar Deviation
timeFrame: 6 months
measure: Range of Motion: Radial Deviation
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusettes General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David C Ring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105039: Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair
Official title: Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Femoral Hernia
Keywords: Pain pattern
overall pain
incisional pain
shoulder pain
visceral pain
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.

Brief summary: Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.

Detailed description: Details about the components of early pain after laparoscopic groin hernia repair are lacking. A description of each component (overall pain, shoulder pain,incisional pain and visceral pain) is needed, so intervention against the different pain components can be targeted.

Patients fill out questionnaires about pain before operation and day 0-3 after operation.

Eligibility criteria: Inclusion Criteria:

* men
* 18-69 years
* uni- or bilateral hernia
* ASA I-II
* Danish speaking

Exclusion Criteria:

* bad compliance
* acute operation
* daily intake of opioids

Primary outcomes:
measure: Overall pain during coughing (visual analog scale)
timeFrame: 3 days
Secondary outcomes:
measure: shoulder pain during coughing (visual analog scale and verbal rating scale)
timeFrame: 3 days
measure: incisional pain during coughing (visual analog scale and verbal rating scale)
timeFrame: 3 days
measure: visceral pain during coughing (visual analog scale and verbal rating scale)
timeFrame: 3 days
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: University Hospital Koge
state: Sealand
Study officials:
affiliation: Koge Hospital
name: Mette A Tolver, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805839: A Study of Imaging in Demyelinating Diseases
Official title: Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Multiple Sclerosis
Inflammatory Demyelinating Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).


Eligibility criteria: Inclusion Criteria:

* Meet the requirements for one of the case or control groups.
* MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.
* Control participants without inflammatory-demyelinating diseases of the central nervous system
* Capacity to sign consent.

Exclusion Criteria:

* Participants unable to lie down without moving for 20 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.

Primary outcomes:
measure: Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
timeFrame: Baseline
measure: Uptake of C-11 ER176 Radiotracer
timeFrame: Baseline
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Burcu Zeydan, MD
role: PRINCIPAL_INVESTIGATOR
References: