louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00582036: Glucose Control In Hematopoetic Stem Cell Transplant
Official title: Glucose Control In Hematopoetic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperglycemia
Hematopoietic Stem Cell Transplantation
Keywords: Hyperglycemia
Hematopoietic stem cell transplantation
Bone marrow transplant
High blood sugar
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
First posted: 2007-12-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

Detailed description: TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18
* Must meet standard criteria for HSCT
* If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm

Exclusion Criteria:

* If on intensive arm patient must stop all oral hyperglycemic meds

Primary outcomes:
measure: Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
timeFrame: 100 days
Secondary outcomes:
measure: Reduction of Infection
timeFrame: About 100 days
measure: Reduced Length of In-hospital Stay
timeFrame: About 100 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: George Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705936: Metaplasticity in Human Pharyngeal Motor Cortex
Official title: Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition
Physiology
Keywords: Non-invasive brain stimulation
Swallowing
Metaplasticity
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.

Detailed description: Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.

Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 18 years old or above; and
* No medical complications or significant past medical history

Exclusion Criteria:

* History of epilepsy;
* Previous history of neurosurgery;
* Previous swallowing problem;
* Implanted brain electrodes, cardiac pacemaker; or
* Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold

Primary outcomes:
measure: Pharyngeal motor evoked potentials (PMEPs)
timeFrame: Change from baseline up to 150 minutes after rTMS
measure: Thenar (hand) motor evoked potentials (TMEPs)
timeFrame: Change from baseline up to 150 minutes after rTMS
Secondary outcomes:
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal Foundation Trust
state: Greater Manchester
Study officials:
affiliation: The University of Manchester
name: Shaheen Hamdy, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096536: Exploring Vancomycin Disposition in Neonates
Official title: Exploring Vancomycin Disposition in Neonates: Paired Analysis of Vancomycin Concentrations Using Immunoassay and Liquid-chromatography-tandem Mass Spectrometry. Determination of Vancomycin Protein Binding and Its Covariates in Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neonatal Infection
Keywords: Neonate
Vancomycin
LC/MS-MS
protein binding
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.

Detailed description: Exploration of vancomycin disposition in neonates:

Objective 1: Paired analysis of (total) serum vancomycin concentrations in neonates using the currently available immunoassay (Cobas c702) versus a reference liquid chromatography-tandem mass spectrometry method (LC-MS/MS).

Objective 2: The determination of vancomycin protein binding and its covariates in neonates.

Eligibility criteria: Inclusion Criteria:

* Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.

Exclusion Criteria:

* No vancomycin therapy
* No signed informed consent available

Primary outcomes:
measure: Differences in vancomycin exposure
timeFrame: 1 year
Secondary outcomes:
measure: Impact of freezing and thawing on vancomycin measurement
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Anne Smits, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427436: Novel Dementia Biomarkers
Official title: Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease, Early Onset
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
Collaborators: name: Otto-von-Guericke University Magdeburg
First posted: 2020-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 50 and 80 years will be recruited from the memory clinic at the Department of Neurology of the Otto von Guericke University Clinic, Magdeburg, Germany. The diagnosis of MCI/AD will be established by experienced neurologists of the memory clinic according to standardised criteria. Control participants will be matched by education, age and gender. These will be recruited through advertisement.

Brief summary: The study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments. Special parameters are being studied that have already been shown to detect changes in the early stages of Alzheimer's dementia.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed MCI patients and matched healthy controls

Exclusion Criteria:

* Metal in body and tatoos;
* Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables
* Alcohol abuse
* Colour blindness
* Pregnancy
* Surgery in the last 6 months
* Uncorrected vision

Primary outcomes:
measure: Locus Coeruleus (LC) Intensity
timeFrame: 15 minutes
measure: Volume of brain regions
timeFrame: 30 minutes
measure: fNIRS-based change in oxyhemoglobin and deoxyhemoglobin
timeFrame: 1 hour
measure: Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)
timeFrame: 1 hour
measure: Heart Rate Variability (HRV)
timeFrame: 1 hour
measure: Score on CERAD-Plus
timeFrame: 30 minutes
measure: Error-rate on Stroop-test
timeFrame: 10 minutes
measure: Error-rate on N-Back-test
timeFrame: 10 minutes
measure: Performance on verbal fluency test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Grassler B, Herold F, Dordevic M, Gujar TA, Darius S, Bockelmann I, Muller NG, Hokelmann A. Multimodal measurement approach to identify individuals with mild cognitive impairment: study protocol for a cross-sectional trial. BMJ Open. 2021 May 25;11(5):e046879. doi: 10.1136/bmjopen-2020-046879.
Clinical trial NCT05605236: Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)
Official title: Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Cancer
Keywords: Bronchial cancer
Bronchopulmonary cancer
Stereotactic radiotherapy
Stereotactic CTV margins
Cell lung cancer
3D radiotherapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019

Brief summary: Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management.

The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer.

Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019
* CT scan available on the HUS imaging server or on CD
* Subject who has not expressed opposition to the use of his or her data for research purposes

Exclusion Criteria:

* Subject who has expressed opposition to participating in the study
* Impossibility to give the subject informed information (difficulties in understanding the subject, ...)
* Subject under legal protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Retrospective histological study of tumor cell dissemination around the tumor
timeFrame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de chirurgie thoracique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01308736: Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Official title: Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: tobacco
nicotine
cigarette smoking
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-03-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.


Eligibility criteria: Inclusion Criteria:

* Must smoke at least 10 cigarettes per day for past 6-months
* Must have a working cellular or land-line phone

Exclusion Criteria:

* Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes
* Must not be currently receiving tobacco dependence treatment counseling
* Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
* Must not have positive screen on SCID-I/NP Psychotic Screen
* Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form

Primary outcomes:
measure: Cigarette Reduction
timeFrame: At 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Division of Addiction Psychiatry
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Marc L Steinberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487136: Interaction Between ABT-335, Rosuvastatin and Warfarin
Official title: Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug Interaction
Pharmacokinetics
Pharmacodynamics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) is 19 to 29, inclusive.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Written informed consent prior to the initiation of screening or study-specific procedures.

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* Subjects taking concomitant medications.
* Subjects with a recent history of surgery or trauma.
* Subjects with a history of any bleeding disorder.

Primary outcomes:
measure: Pharmacokinetic parameters, pharmacodynamic variables
timeFrame: Day 24
Secondary outcomes:
measure: Vital signs, physical examinations, laboratory tests, ECGs, adverse events
timeFrame: Day 29
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Ref # / Investigator 5290
state: Arkansas
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06109636: Correlation Analysis Between Corneal Biomechanics and Anterior Segment
Official title: Correlation Analysis Between In-vivo Corneal Biomechanical Properties and Anterior Segment in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ciliary Muscle Thickness
Anterior Sclera Thickness
Corneal Biomechanics
CASIA2
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients premedicated for refractive surgery

Brief summary: Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Clarify whether aqueous humor displacement, anterior sclera, and ciliary muscles influence the assessment of in vivo corneal biomechanics.


Eligibility criteria: Inclusion Criteria:

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;

Exclusion Criteria:

1. Corneal disease;
2. Ocular trauma;
3. Previous ocular surgery;
4. Any anterior segment diseases except cataract;
5. Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination;
6. Pregnant and lactating women;

Primary outcomes:
measure: scleral and ciliary muscle thickness
timeFrame: one year
measure: biomechanical parameters
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04792736: Prognostic Value of Lactates in ICU
Official title: Prognostic Value of Lactates in Predicting Intensive Care Unit Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Keywords: Lactates
Prognosis
intensive care units
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted in ICU after major trauma or surgery or for medical reasons.

Brief summary: he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.

Detailed description: In this study, conducted over o 12 months period, arterial blood lactates levels were measured in ICU patients at admission (H0), every 6 hours during the first day and and H48.

This trial included traumatic, medical and surgical patients requiring ICU stay for a predictive period \> to 24 hours.

Blood lactates were evaluated as a prognostic parameter in predicting ICU mortality and compared to classic prognostic scores such as: SOFA score, IGS II and APACHE II.

The primary end point was ICU mortality.

Eligibility criteria: Inclusion Criteria:

* All adults admissions in ICU with a predicted length of stay \> 24 hours

Exclusion Criteria:

* Patients who died during the first 24 hours after ICU admission

Primary outcomes:
measure: ICU Mortality
timeFrame: 28 days after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim University Hospital
state: Tunis
city: Tunis
country: Tunisia
facility: Mongi Slim Hospital
Study officials:
References:
Clinical trial NCT01095536: Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy
Official title: The Observational Cohort Study to Identify Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Pain
Nausea
Vomiting
Keywords: laparoscopic cholecystectomy, elective
anesthesia, general
shoulder pain
nausea
vomiting
laparoscopic cholecystectomy
general anesthesia
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2010-03-30
Enrollment: 380
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective laparoscopic cholecystectomy

Brief summary: Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. Moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Detailed description: The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* \> 21 years old,
* Chinese patient

Exclusion Criteria:

* current pregnancy,
* patients with history of upper laparotomy,
* inability to communicate before operation,
* persistent emesis or shoulder pain before operation,
* patients who converted to open cholecystectomy,
* receiving postoperative ventilator support,
* unstable postoperative condition or major complications.

Primary outcomes:
measure: incidence of postoperative shoulder pain and emesis
timeFrame: within postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
affiliation: Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan
name: Chiu-Ming Ho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: