louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02154854: Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)
Official title: Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: De Novo Transplant Disease
Keywords: Renal
Transplantation
Tacrolimus
Arterial stiffness
Vascular fibrose plasma markers
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2014-06-03
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Age between 18 et 70 years
* Patient accepting to give a written informed consent
* Recipients of a first renal allograft (deceased or living, non HLA identical donor with compatible ABO blood type)
* Randomized in the ADEQUATE study
* Patients must have at J112 +/- 3 days a stable renal function (MDRD 4) with an absence of DSA since transplantation.
* Negative T cross-match in cytotoxicity
* Tolerate a daily dose of MMF at 1g

Exclusion Criteria:

* Acute rejection during the first months
* Existence of a BK infection since M3
* Proteinuria/reatininuria ratio \> 1g/g since M3

Primary outcomes:
measure: Aorta stiffness at one year post-tranplantation
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 months
measure: Endothelial activation at one year post-tranplantation
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU de Amiens
city: Angers
country: France
facility: CHU de Angers
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Necker
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: University Hospital, Rouen
name: Robinson JOANNIDES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03682354: ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
Official title: Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Keywords: Erector spinae plane block
Video-assisted thoracic surgery;
Intercostal nerve block
Patient-controlled intravenous analgesia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery

Detailed description: For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.

The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.

Eligibility criteria: Inclusion Criteria:

* Patients to receive video assisted thoracoscopic lobectomy or bullectomy .

Exclusion Criteria:

* 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.

Primary outcomes:
measure: Pain score (NRS)
timeFrame: 4 hours from the end of procedure
Secondary outcomes:
measure: Pain score (NRS)
timeFrame: 8, 24,48 hours from the end of procedure
measure: Analgesics consumption
timeFrame: During operation,4, 8, 24,48 hours from the end of procedure
measure: Incidence of side effects and complication during study
timeFrame: During operation,4, 8, 24,48 hours from the end of procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Min Li
role: STUDY_CHAIR
References:
Clinical trial NCT01431833: A PK and Safety Study in Subjects With Hepatic Impairment
Official title: A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment
Matched control subjects
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

Detailed description: This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.

Eligibility criteria: Inclusion Criteria:

* Moderate or severe hepatic impairment or matched control
* BMI between 18.0 and 40.0 kg/m2

Exclusion Criteria:

* Evidence of acute deterioration of hepatic function within 8 weeks
* ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
* Total bilirubin \> 5 mg/dl for moderates; no upper limit for severes
* Hemoglobin \< 10g/dl for moderates; Hemoglobin \< 9g/dl for severes

Primary outcomes:
measure: PK Assessment
timeFrame: 7 days
Secondary outcomes:
measure: Safety
timeFrame: 7 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Trius Investigator Site 001
state: Florida
city: Minneapolis
country: United States
facility: Trius Investigator Site 002
state: Minnesota
Study officials:
affiliation: Trius Therapeutics
name: Phillippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.
Clinical trial NCT03735433: The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia
Official title: The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: aspirin
obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.

Detailed description: Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.

Eligibility criteria: Inclusion Criteria:

* BMI at enrollment \>/= 30
* plan for ASA for preeclampsia prevention

Exclusion Criteria:

* BMI \< 30
* already on ASA

Primary outcomes:
measure: Incidence of Diagnosis of Preeclampsia
timeFrame: Through study completion, an average for 10 months
Secondary outcomes:
measure: Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2
timeFrame: Through study completion, an average for 10 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Medical Center Labor and Delivery Unit
state: Ohio
Study officials:
References:
Clinical trial NCT04685733: Caretaker Hemodynamic Parameters Validation
Official title: Caretaker Hemodynamic Parameters Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Cardiac Output
Left Ventricular Ejection Time
Heart Rate Variability
Lead sponsor: CareTaker Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
name: Yale University
name: Orange County Research Center
First posted: 2020-12-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be patients, \> 18 years of age, who are able and willing to participate and have given written assent

Brief summary: Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed description: Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.

Eligibility criteria: Inclusion Criteria:

* 18 years of age, who are able and willing to participate and have given written assent

Exclusion Criteria:

* Unable to give written assent

  * \<18 years of age
  * No or poor finger pulse, as determined through visual inspection for ischemic hands

Primary outcomes:
measure: Blood pressure performance comparison
timeFrame: Paired beat-by-beat readings over maximum of 2.5 hours session length
measure: Cardiac output performance comparison
timeFrame: Paired measurements over approximately 1 hour time frame
measure: Left ventricular ejection time comparison
timeFrame: Paired measurements over approximately 1 hour time frame
measure: Heart rate variability measures comparison
timeFrame: Paired beat-by-beat readings over maximum of 2.5 hours session length
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Caretaker Medical
state: Virginia
Study officials:
affiliation: Caretaker Medical
name: Martin Baruch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398133: Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
Official title: Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Asthma
Eosinophilic Asthma
Keywords: eosinophil
COPD
asthma
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD and asthma patients fulfilling the inclusion and exclusion criteria will be recruited from the outpatient clinic.

Brief summary: Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD according to GOLD 2019 or asthma according to GINA 2021
* Peripheral blood eosinophil count ≥ 100 / μL
* Age ≥40 years (COPD), ≥18 years (asthma)
* History of cigarette smoking: ≥10 pack-years (for COPD)
* Stable disease period (at least 3 months without exacerbation)
* Exclusion of parasitic diseases
* Informed consent to participate in the study

Exclusion Criteria:

* COPD and asthma overlap
* Use of systemic corticosteroids in the 3 months prior to the study
* Respiratory infection or exacerbation in the 3 months prior to the study
* Acute and chronic respiratory failure
* Concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases
* Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study
* Contraindications to sputum induction
* No consent to participate in the study

Primary outcomes:
measure: expression of surface markers
timeFrame: performed up to 3 months after blood and sputum collection
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Banacha Hospital
Study officials:
References:
Clinical trial NCT03294733: The Relationship Between Age and Carpal Tunnel Size
Official title: The Relationship Between Age and Carpal Tunnel Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ultrasound carpal tunnel size on subjects
Primary purpose: DIAGNOSTIC

Brief summary: Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.

Detailed description: Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.

Eligibility criteria: Inclusion Criteria:

* Greater than age 18 having bilateral wrists amenable to ultrasound examination.

Exclusion Criteria:

* Active carpal tunnel syndrome,
* history of carpal tunnel syndrome
* any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)
* distal radius fracture deformity
* rheumatoid arthritis
* open wounds or lesions of the hand or forearm
* known congenital deformities of the upper extremity.

Primary outcomes:
measure: Size of carpal tunnel
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Peter M Murray
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04203433: A Study of DLX105-DMP in Subjects With Plaque Psoriasis
Official title: A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque Psoriasis
Lead sponsor: DelArrivo, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion


Eligibility criteria: Key Inclusion Criteria:

* Signed and dated informed consent.
* Subjects aged 18-75 years.
* Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
* Stable chronic mild-to-moderate plaque psoriasis.

Key Exclusion Criteria:

* Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
* Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.
* Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1

Primary outcomes:
measure: Local Tolerability Sensations
timeFrame: Up to 4 Weeks
measure: Local Site Application Assessment
timeFrame: Up to 4 Weeks
measure: Adverse Events
timeFrame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
measure: Local Investigator Global Assessment (IGA)
timeFrame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
measure: Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
timeFrame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Secondary outcomes:
measure: Pharmacokinetic Parameters
timeFrame: Day 1, Day 15, and Day 25
measure: Immunogenicity Testing
timeFrame: Up to 4 Weeks after Last Dose
Other outcomes:
Locations:
city: Alpharetta
country: United States
facility: DelArrivo Investigational Site
state: Georgia
city: Philadelphia
country: United States
facility: DelArrivo Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: DelArrivo Investigational Site
state: Texas
city: Norfolk
country: United States
facility: DelArrivo Investigational Site
state: Virginia
Study officials:
References:
Clinical trial NCT04490733: Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer
Official title: Developing Risk Prediction Model of Mild Cognitive Impairment in Patients With Colorectal Cancer From Active Treatment to Survivor and Testing the Effect of Dual Task Walking on Improving Cognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
cognitive impairment
chemotherapy
dual-task walking
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 355
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this three-year study are to explore cognitive function under different stages of colorectal cancer (CRC) and its related factors; and understand its disturbance and coping process caused by cancer-induced cognitive impairment (CICI) from patient perspective; and further to test effect of dual-task walking on improving cognitive function in CRC patients.

Detailed description: Developing risk prediction model of mild cognitive impairment in patients with colorectal cancer from active treatment to survivor by exploring the effect of surgery and chemotherapy on CICI, and to identify high risk population; and testing the effect of dual-task walking on improving cognitive function (memory, executive function and attention) in CRC patients.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed stage I to III colorectal cancer and Montreal Cognitive Assessment (MoCA) \< 24.

Exclusion Criteria:

* Patients with cancer other than colorectal cancer or have cancer recurrence.

Primary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline cognitive function at 12 months
measure: Neuropsychological battery test
timeFrame: Change from baseline cognitive function at 12 months
measure: Neuropsychological battery test
timeFrame: Change from baseline cognitive function at 12 months
measure: Neuropsychological battery test
timeFrame: Change from baseline cognitive function at 12 months
Secondary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline symptom at 12 months
Other outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline fatigue at 12 months
measure: Self-report Questionnaire
timeFrame: Change from baseline depression symptom at 12 months
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Shiow-Ching Shun, PHD
role: STUDY_CHAIR
References: