louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01172353: Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
Official title: Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Failure
Keywords: contras-induced nephropathy
Lead sponsor: Hospital Sao Lucas da PUCRS
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 301
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 purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.


Eligibility criteria: Inclusion Criteria:

* serum creatinine \> 1.1 mg/dL
* glomerular filtration rate (GFR) \< 50 mL/min

Exclusion Criteria:

* age \< 18 years
* use of radiographic contrast media during the last 21 days
* history of dialysis
* cardiac insufficiency class III-IV
* emergency procedures

Primary outcomes:
measure: Contrast-induced Nephropathy
timeFrame: 48 hours
Secondary outcomes:
measure: Dialysis During Hospitalization
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: São Lucas Hospital - PUCRS University
state: RS
Study officials:
References:
Clinical trial NCT01620853: Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)
Official title: Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small cell lung cancer (NSCLC)
ALK probe
FISH
Chromosomal aberrations
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having non-small cell lung cancer (NSCLC)

Brief summary: The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) .

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.

Detailed description: The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with XALKORI® (crizotinib).

Eligibility criteria: Inclusion Criteria:

* Well stained slides with bright FISH signals

Exclusion Criteria:

* Very old slides that were already bleached

Primary outcomes:
measure: IVD study
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Temple,
country: United States
facility: Scott & White Hospital,
state: Texas
Study officials:
References:
Clinical trial NCT03128177: Nocturnal Hypertension and Non-Dipping Blood Pressure
Official title: Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: nocturnal hypertension
non-dipping blood pressure
obstructive sleep apnea
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-04-25
Enrollment: 59
Sex: ALL
Minimum age (years): 48
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover study of high (6 g) and low (1.5 g) sodium diet
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if high salt diet contributes to high nighttime blood pressure. The investigators will determine if high compared to low salt diet increases 24-hour blood pressure levels. The investigators will also determine if high salt diet affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also determine how high salt diet affects the activity of certain genes related to control of blood pressure. A total of 60 participants will be enrolled in the study.


Eligibility criteria: Inclusion Criteria:

* Nocturnal hypertension

Exclusion Criteria:

* Stage 2 clinic hypertension
* History of congestive heart failure
* Chronic kidney disease,
* Diabetes with insulin use
* History of a cardiovascular event
* Pregnant or nursing
* Current use of continuous positive airway pressure
* Shift work
* A known circadian rhythm disorder

Primary outcomes:
measure: 24-hour blood pressure
timeFrame: Baseline to 7 days after start of dietary period
Secondary outcomes:
measure: Obstructive sleep apnea
timeFrame: Baseline to 7 days after start of dietary period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: David A. Calhoun, MD
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01075477: An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)
Official title: Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 151
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 with rheumatoid arthritis on or commencing treatment with rituximab \[MabThera\]

Brief summary: This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* rheumatoid arthritis
* treatment with rituximab

Exclusion Criteria:

* unable/unwilling to give informed consent to data collection

Primary outcomes:
measure: Efficacy: DAS28
timeFrame: 29 months
Secondary outcomes:
measure: Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)
timeFrame: 29 months
measure: Safety: serious and non-serious adverse events
timeFrame: 29 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Hämeenlinna
country: Finland
city: Joensuu
country: Finland
city: Jyvaeskylae
country: Finland
city: Paimio
country: Finland
city: Riihimäki
country: Finland
city: Seinäjoki
country: Finland
city: Tampere
country: Finland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01325077: Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
Official title: Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Satisfaction
Keywords: Nurse-based, acute pain service, pediatric, postoperative,
pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 103
Sex: ALL
Minimum age (years): 31
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?

Detailed description: Comparison of 2 treatment model in reducing prevalence of postoperative pain in pediatric patients:

Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.

Eligibility criteria: Inclusion Criteria:

* Age up to15 years old
* Underwent surgery with moderate to severe pain

Exclusion Criteria:

* ENT, Eye, ambulatory surgery
* Cardiac, Neurosurgery
* Severe neurocognitive impairment
* Continuous epidural analgesia which anesthesiologists take care by themselves

Primary outcomes:
measure: prevalence of patients with moderate to severe pain more than once in first postoperative day
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Suwannee Suraseranivongse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844477: Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
Official title: Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Management
Nerve Block
Laparoscopic Adrenalectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 25
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: SUPPORTIVE_CARE

Brief summary: This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Primary outcomes:
measure: pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery
timeFrame: At 12hours after the surgery
Secondary outcomes:
measure: The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 2,4, 8, 12,24 ,48,72hours after the surgery
measure: incidence of postoperative nausea and vomiting (PONV)
timeFrame: within 24 postoperative hours
measure: ambulation time
timeFrame: within5 days after surgery
measure: time of restart anal exhaust
timeFrame: within 5 days after surgery
measure: Postoperative length of hospital stay
timeFrame: up to2 weeks after surgery
measure: patient's satisfaction with anesthesia and analgesia
timeFrame: 48 hours after surgery
measure: The pain scores at activity determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 2,4, 8, 24 ,48,72hours after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xulei CUI, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01417377: An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)
Official title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 22
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 with chronic kidney disease

Brief summary: This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, age 18 years or above
* Chronic kidney disease (CKD) with anemia
* Patients on dialysis receiving short-acting epoetin (EPO)
* Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%

Exclusion Criteria:

* Patients unwilling to give informed consent
* Uncontrolled hypertension
* Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
* Relevant acute or chronic bleeding history
* Hemolysis
* Hemoglobinopathies
* Pure red cell aplasia

Primary outcomes:
measure: Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
timeFrame: Month 4 up to Month 6
Secondary outcomes:
measure: Time to Achieve Hb Level to 11-12 g/dL
timeFrame: Up to 6 months
measure: Number of Dose Adjustments Required to Maintain Hb Levels
timeFrame: Up to 6 months
measure: Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayed Hospital; Department of Nephrology
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital; Nephrology
city: Lahore
country: Pakistan
facility: Doctor's Hospital and Medical Centre
city: Lahore
country: Pakistan
facility: Khair-un-Nisa Hospital
city: Lahore
country: Pakistan
facility: Surgimed Hospital
city: Peshawar
country: Pakistan
facility: Northwest General Hospital; Department of Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00702377: Evaluation of SYSTANE Ultra Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 109
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: To evaluate the safety and efficacy of two artificial tears in dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eyes
* Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Tear Break-up Time
timeFrame: Day 0, Day 7, Day 14, Day 28, and Day 42
measure: Conjunctival Staining
timeFrame: Day 0, Day 7, Day 14, Day 28, Day 42
measure: Corneal Staining
timeFrame: Day 0, Day 7, Day 14, Day 28, Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Call Center for Locations
state: Texas
Study officials:
References:
Clinical trial NCT05759377: V-A ECMO AUTO Mode Registry
Official title: Abiomed Impella V-A ECMO AUTO Mode - Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with concomitant VA ECMO and Impella CP® heart pump (ECpella) due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis).

Brief summary: Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Detailed description: The overall objective of this study is to collect data during routine Impella usage in an ECpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated Impella mode to run in conjunction with a VA ECMO system for continued assessment and development of the underlying algorithms in different clinical settings.

The primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm for the Impella pump. This is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the AIC out of the operational console data.

Eligibility criteria: Inclusion Criteria:

* Patients with ongoing or planned ECpella therapy

Exclusion Criteria:

* Age \< 18 years
* Treatment with other than VA ECMO setup
* Treatment with Impella CP® heart pump only

Primary outcomes:
measure: Gather clinical event data
timeFrame: Until one of the devices is permanently weaned, on average 5 days
measure: Usability assessment
timeFrame: Until study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
state: NRW
city: Bad Oeynhausen
country: Germany
facility: HDZ NRW
state: NRW
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
state: Saxony
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Marburg
country: Germany
facility: UKGM Universtitätsklinikum Marburg
city: Trier
country: Germany
facility: Brüderkrankenhaus Trier
Study officials:
affiliation: Uniklinik RWTH Aachen
name: Alexander Kersten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936477: Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
Official title: Functional Morphometry and Ventilation Perfusion Ratio to Estimate the Alveolar Surface Area in Prematurely Born Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2021-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Congenital or chromosomal anomalies

Primary outcomes:
measure: Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Anne Greenough
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712777: Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism
Official title: Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ocular Physiology
Intraocular Pressure
Keywords: Brimonidine
alpha 2 receptor polymorphism
Intraocular Pressure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. The reason for this interindividual variability is not entirely clear. Obviously differences in pharmacokinetic properties due to variable penetration of the drug through the cornea may be responsible. Alternatively, polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering efficacy of topical brimonidine. This hypothesis is tested in the present study. Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally important, particularly a polymorphism of the alpha-2B receptor, which has a high allele frequency in caucasians.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* IOP between 12 and 16 mmHg
* Normal ophthalmic findings, ametropia \< 3 Dpt.
* Results of alpha-2B receptor genotyping; subjects who fall within one of the following groups: group 1: homozygote mutant: I/I (n=40); group 2: homozygote mutant: D/D (n=40)

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: in total 10 minutes
measure: alpha-2B receptor genotyping
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
References: