louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00199641: Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients
Official title: Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: -Mechanically Ventilated Patients
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.


Eligibility criteria: Inclusion Criteria:

* Adult (\> 18 ans)
* Mechanical ventilation for \> 72 hours
* Planned enteral nutrition
* Informed consent

Exclusion Criteria:

* Body Mass Index \< 20 kg/m2
* Enteral nutrition non indicated (ileus, splanchnic ischemia..)
* Shock (use of catecholamines, arterial blood pressure \< 90 mmHg, peripheral hypoperfusion, elevation of lactates \> x 1,5 normal value)
* Contraindications for gastric tube
* Pregnancy
* Previous enrollment in the present study

Primary outcomes:
measure: Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume)
Secondary outcomes:
measure: -Measured nutrition amount when compared to theorical nutrition during ICU stay
measure: -Measured nutrition amount when compared to theorical nutrition during the first three days
measure: -Influence of prokinetic drugs on nutrition quality
Other outcomes:
Locations:
city: Angouleme
country: France
facility: Service de Réanimation
city: Limoges
country: France
facility: Service de réanimation Polyvalente
Study officials:
affiliation: University Hospital, Limoges
name: Bruno François, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709341: Transradial-Band Pilot Study
Official title: Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery Incision Site Closure
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Have an acceptable Barbeau test (i.e. type A through C)
* Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
* The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.
* The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al16.
* INR less than 1.5
* Platelet count greater than 50,000 platelet/uL
* Prothrombin time less than 15 seconds

Exclusion Criteria:

* If there is an unacceptable risk of bleeding diathesis, or
* If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.

Primary outcomes:
measure: Percentage of Participants With Bleeding
timeFrame: an average of 12 hours post procedure
measure: Percentage of Participants With Bleeding
timeFrame: 30 days post procedure
measure: Left Radial Artery Occlusion
timeFrame: 30 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT05324319: Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
Official title: Single Blinded Randomized Controlled Trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or ChAdOx1-S (Viral Vector) for Third Vaccination in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mRNA vaccine.


Eligibility criteria: Inclusion Criteria:

* patient has received a kidney transplantation
* full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening
* \> 18 years of age
* no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine

Exclusion Criteria:

* acute illness with fever
* Prior documented infection with SARS-CoV-2
* triple anticoagulation therapy
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
* Subject is pregnant or breast feeding

Primary outcomes:
measure: Seroconversion at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Seroconversion at 12 weeks
timeFrame: 3 months
measure: SARS-CoV-2 antibody levels at 4 weeks
timeFrame: 4 weeks
measure: SARS-CoV-2 antibody levels at 12 weeks
timeFrame: 3 months
measure: Seroconversion at 36 weeks
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medicial University of Vienna
Study officials:
References:
Clinical trial NCT01286519: Pharmacokinetics of Off Label Pediatric Medications
Official title: Pharmacokinetics of Off Label Pediatric Medications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Off Label Use of Medications in Pediatric Patients
Keywords: pharmacokinetics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children \< 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Brief summary: The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Detailed description: There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

Eligibility criteria: Inclusion Criteria:

* Children less than 8 years of age
* Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Exclusion Criteria:

* Lack of consent

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.
measure: Volume of distribution at steady-state
timeFrame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
measure: Terminal elimination rate constant (Ke) and Half-Life
timeFrame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
measure: Plasma Clearance
timeFrame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina NC Children's Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Matthew M. Laughon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03890419: Opioid Sparing Potential of Light-Induced Analgesia
Official title: Opioid Sparing Potential of Light-Induced Analgesia: a Pilot Trial of a Novel, Non-Pharmacological Treatment for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Acute Pain
Chronic Pain
Opioid Use
Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 94
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 is a pilot trial testing the potential opioid-sparing analgesic effect of a novel non-pharmacological treatment using visualized light spectrums. Preclinical findings have shown such treatments to alter pain perception.


Eligibility criteria: Inclusion Criteria:

* Scheduled for thoracic surgery for which post-operative opioid PCA is anticipated (Acute Pain group) OR currently treated with opioid therapy for fibromyalgia (Chronic Pain group)
* 18 years of age and older
* Able to wear study eyeglasses for at least 4 hours per day
* Agree to participate and provide written informed consent and HIPAA authorization

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Pain Level
timeFrame: Baseline to end of study
measure: Change in Opioid Dose Used for Pain
timeFrame: Baseline to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
Study officials:
affiliation: Duke University
name: Padma Gulur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05040919: Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
Official title: Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrythmia -Myocardial Infarction
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 652
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: every adult patient with a STEMI in prehospital, manage by a physician and bring to the CHU of Dijon

Brief summary: The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.

We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia


Eligibility criteria: Inclusion Criteria:

\> 18 years old, with STEMI, in prehospital patient, take by a medecine, bring to the CHU Dijon

Exclusion Criteria:

\< 18 years old, without STEMI, no medical in prehospital

Primary outcomes:
measure: arrhythmia
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT05888519: Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Official title: Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Detailed description: Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Eligibility criteria: Key Inclusion Criteria:

* Sign an Informed Consent;
* Have dry eye symptoms;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Ocular abnormalities;
* Active ocular infection or inflammation not associated with dry eye;
* History of ocular or intraocular surgery;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Best corrected visual acuity (BCVA) with manifest refraction, at distance
timeFrame: Day 1, each wear period. A wear period is 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: George Street Eye Centre
state: New South Wales
city: Teneriffe
country: Australia
facility: Ophthalmic Trials Australia
state: Queensland
city: Carlton
country: Australia
facility: University of Melbourne, Department of Optometry and Vision Science
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Dry Eye
role: STUDY_DIRECTOR
References:
Clinical trial NCT02637219: Innate Immune Response in COPD
Official title: Innate Immune Response in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Immunity, Innate
Inflammation
Bronchitis, Chronic
Toll-Like Receptors
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: University of Washington
name: Novartis Pharmaceuticals
First posted: 2015-12-22
Enrollment: 30
Sex: MALE
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical history of COPD recruited from a pulmonary subspecialty clinic at an academic medical center

Brief summary: The purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD.

Detailed description: The airways of COPD patients are often colonized with bacteria leading to increased airway inflammation. This study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.

In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses were measured in whole blood ex vivo. We used PAMPs derived from microbial products recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced cytokine levels in blood from patients with and without severe COPD, and for subjects with and without chronic bronchitis.

Eligibility criteria: Inclusion Criteria:

* post-bronchodilator FEV1/FVC \<0.7
* FEV1 \< 80%
* \> 10 pack-years tobacco smoking
* no respiratory illnesses or prednisone or antibiotics in the last 4 weeks

Exclusion Criteria:

* Primary diagnosis of asthma
* \> 15% change in FEV1
* Chronic inflammatory or infectious disease
* Cancer
* Autoimmune disease
* Chronic renal failure with a creatinine \> 1.5
* Chronic liver disease
* Chronic antibiotic use

Note: Due to difficulty recruiting patients after 6 participants were enrolled, the exclusion criteria were modified to allow patients with \> 15% change in FEV1. The exclusion criteria were also changed to allow chronic renal failure not requiring dialysis, and non-metastatic cancer provided there was no diagnosis of lung cancer.

Primary outcomes:
measure: Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1).
timeFrame: This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Vincent Fan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329419: HEPSERA Post Marketing Surveillance
Official title: A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 4393
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 administrated adefovir dipivoxil at the site

Brief summary: An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information

Detailed description: This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.

Eligibility criteria: Inclusion Criteria:

* Patients administrated adefovir dipivoxil at the site

Exclusion Criteria:

* Patients administrated adefovir dipivoxil before center initiated date

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With a Serious Adverse Event
timeFrame: 12 weeks
measure: Number of Participants With the Indicated Unexpected Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06181019: Acupuncture Combined With Mirabegron in the Treatment of OAB
Official title: Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Overactive Bladder
Keywords: overactive bladder
mirabegron
acupuncture
nocturia
incontinence
Lead sponsor: The Affiliated Ganzhou Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks, whereas patients in the treatment group were treated with acupuncture combined with mirabegron.
Primary purpose: TREATMENT

Brief summary: Introduction: As conventional treatments for overactive bladder (OAB) have not yet shown satisfactory results, new approaches are needed. Therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of OAB.

Methods: This prospective cohort study enrolled 80 OAB patients who were then divided into control and treatment groups using a randomized number-table method. The control group was administered mirabegron alone (50 mg/day), while the treatment group was administered mirabegron orally along with acupuncture at the following points: guanyuan (CV4), zhongji (CV3), and sanyinjiao (SP6). The OAB symptom score (overactive bladder syndrome score \[OABSS\]), voiding, urgency, nocturia, incontinence, and incidence of related adverse events were compared between the two groups at baseline and after 4, 8, and 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of OAB
* Good compliance
* Good communication skills

Exclusion Criteria:

* Age \<14 or \>75 years
* History of use of M-blockers in the recent 4-6 weeks
* History of use of α-blockers in the recent 4-6 weeks
* History of use of mirabegron in the recent 4-6 weeks
* Diagnosis with a combined urinary tract tumor
* Inability to cooperate with this study
* Pregnancy
* Postvoid residual urine volume \>150 mL

Primary outcomes:
measure: Overactive bladder syndrome scores (OABSS)
timeFrame: 4, 8, and 12 weeks after treatment
measure: voiding diary indicators (voiding, urgency, nocturia, and incontinence)
timeFrame: 4, 8, and 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
Study officials:
affiliation: Ganzhou People's Hospital
name: Xiaolin Deng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000319: Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2
Official title: Buprenorphine Maintenance Dose Schedule and Treatment Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of treating opioid-dependent individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Depression
measure: Withdrawal symptoms
measure: Opioid and cocaine use
measure: Social and psychological functioning
measure: AIDS risk behavior
measure: Opiate withdrawal symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References: