louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04953923: Thorough QT Assessment of Cedazuridine in Healthy Subjects
Official title: A Randomized, Double-blinded, Double-dummy, Placebo-controlled Thorough QTC Study With Single Oral Doses of Cedazuridine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.


Eligibility criteria: Inclusion Criteria:

* Male or female who is not of childbearing potential
* Body mass index of 18.0 to 32.0 kg/m\^2, inclusive

Exclusion Criteria:

* QTcF \>450 msec at screening
* Clinically relevant abnormalities in conduction parameters; or if PR interval \> 200 msec, QRS duration \> 110 msec, or bradycardia or tachycardia (HR \<45 bpm or \>100 bpm)
* History or presence of hypokalemia, hypomagnesemia, or hypocalcemia
* Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days
* Family history of Long QT Syndrome or family history of TdP
* Sick sinus syndrome, atrioventricular block (any degree)
* Myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities
* Repeated or frequent syncope or vasovagal episodes
* Resuscitated arrest possibly due to TdP; hypertension, angina, or severe peripheral arterial circulatory disorders
* Use of concomitant medications that prolong the QT/QTc interval

Primary outcomes:
measure: Change from baseline in QTcF
timeFrame: Baseline and Day 20
Secondary outcomes:
measure: Change from baseline in QTcF
timeFrame: Baseline and Day 20
measure: Safety: Participants with adverse events
timeFrame: Up to Day 20
measure: Change from baseline in heart rate
timeFrame: Baseline and Day 20
measure: Change from baseline in PR interval of the electrocardiogram (ECG)
timeFrame: Baseline and Day 20
measure: Change from baseline in QRS interval of the electrocardiogram (ECG)
timeFrame: Baseline and Day 20
measure: Change from baseline in T-wave morphology
timeFrame: Baseline to Day 20
measure: Pharmacokinetic parameter: Cmax
timeFrame: Up to Day 20
measure: Pharmacokinetic parameter: Tmax
timeFrame: Up to Day 20
measure: Pharmacokinetic parameter: AUClast
timeFrame: Up to Day 20
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
References:
Clinical trial NCT00502723: Multicentric Study Comparing Carcinological and Functional Results of Surgery
Official title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of the PROSTATE
Keywords: Retropubic Prostatectomy
Surgical Procedures
Laparoscopic
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 1440
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Detailed description: The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.

Eligibility criteria: Inclusion Criteria:

* Male, old patient of less than 70 years,
* having a prostate cancer proven histologically, requiring a radical prostatectomy.
* Clinical stage T1c and rate of PSA (with 20 ng/ml).
* Osseous scintiscanning and abdomen-pelvic scanner negative.
* Patient informed of the study and its participation.
* Patient affiliated to a social security system.

Exclusion Criteria:

* Contra-indication with the surgery or the anaesthesia.
* Antecedent of prostate resection or adenomectomy.
* Antecedent of inguinal hernia treatment.
* Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
* Patient privatized of freedom.

Primary outcomes:
measure: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
timeFrame: during the study
Secondary outcomes:
measure: Carcinological (percentage of positive surgical margins, percentage of capsular crossing).
timeFrame: after the surgical
measure: Functional (urinary continence, sexuality, quality of life)
timeFrame: at 2 years
measure: per and post operational morbidity
timeFrame: during the 36 months
measure: economic
timeFrame: duration and cost of hospitalization
Other outcomes:
Locations:
city: Creteil
country: France
facility: Groupe Hospitalier Albert Chenevier Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claude ABBOU, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572723: Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty
Official title: Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinoplasty
Dexmedetomidine
Remifentanil
Keywords: Remifentanil
dexmedetomidine
pain
recovery
shivering
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The investigators compared the effects of remifentanil and dexmedetomidine administered under general anesthesia on hemodynamics, postoperative pain, recovery, postoperative nausea, vomiting, shivering, patient's and surgeon's satisfaction in patients undergoing elective rhinoplasty. A single-center, prospective, blinded, randomized controlled trial. After the approval of the hospital ethics committee (KA22/12), fifty volunteers aged 18-65 years who underwent rhinoplasty under elective conditions accepted the study in the American Society of Anesthesiologists (ASA) I-III class. The patients were randomly divided into the remifentanil group (group R) and the dexmedetomidine group (group D). Group R (n=25) was initially to receive remifentanil 0.01-0.2 g/kg/min without intraoperative loading. Group D (n=25) dexmedetomidine, was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as an infusion during surgery.


Eligibility criteria: Inclusion Criteria:

Patients who will have rhinoplasty surgery American Society of Anesthesiologists (ASA) I- II class

Exclusion Criteria:

Patients with end-stage liver or kidney disease Uncontrolled hypertension Any type of atrioventricular block, pacemaker Heart failure Diabetes mellitus Chronic obstructive or interstitial lung disease, severe asthma Neurological or psychiatric disease, substance abuse Pregnant or lactating women

Primary outcomes:
measure: Mean arterial pressure
timeFrame: During surgery
measure: Postoperative pain
timeFrame: Up to 30 minutes after the patient wakes up.
measure: Patient Recovery Time
timeFrame: Postoperative 1. hours
Secondary outcomes:
measure: Postoperative nausea and vomiting scores
timeFrame: postoperative first 6 hours and 24 hours
measure: Patient satisfaction
timeFrame: Postoperative 6. hours
measure: Surgeon satisfaction
timeFrame: Postoperative 0. hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Medical School
Study officials:
References:
Clinical trial NCT04059523: MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
Official title: A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-16
Enrollment: 62
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects 9 years of age or older.
2. Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
3. Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
4. All females of child-bearing potential and premenarchal, excluding women who are surgically sterile

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
2. Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
3. Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
4. Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.

Primary outcomes:
measure: Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
Study officials:
References:
Clinical trial NCT03520023: Critical Care and Palliative Care Medicine Together in the ICU
Official title: Does Early vs Usual Palliative Care Consultation Augment the Critical Care Physician to Decrease Healthcare Utilization and Increase Caregiver Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Intensive Care Unit
Hospice
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 95
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: Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.


Eligibility criteria: 1. Age \>80 years
2. Apache II score \>14
3. SOFA score \> 9
4. Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.)
5. Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed)
6. Stage 4 metastatic disease
7. Consideration to place permanent feeding tube or trach
8. Recurrent ICU admissions in the past year
9. Post-cardiac arrest
10. End-stage disease (lung, ESRD, ESLD)
11. ICU perceived need

Primary outcomes:
measure: Patient satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: ICU length of stay
timeFrame: 1 year
measure: Ventilator Days
timeFrame: 1 year
measure: Percentage admission to hospice
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: John E Moss
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02919423: TMS Modulation of Insula-related Brain Networks.02
Official title: TMS Modulation of Insula-related Brain Networks.02
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.


Eligibility criteria: Inclusion Criteria:

* generally healthy
* between the ages of 18-55
* right-handed

Exclusion Criteria:

* significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
* current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
* meet DSM-5 criteria for current substance use disorder other than nicotine
* use of psychoactive medications that would result in a positive urine drug screen
* Current use of medications known to lower the seizure threshold
* positive breath alcohol concentration
* presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
* among women, a positive urine pregnancy test
* vision that cannot be corrected to 20/40

Primary outcomes:
measure: Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
timeFrame: baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Merideth Addicott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820923: Transcranial Brain Stimulation in Vegetative State Patients
Official title: Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetative State
Minimally Conscious State
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29.
* Age between 18 and 65 years.
* Time from the lesion: more than 4 months.
* Stable clinical condition.
* written consent fron the legal administrator of the patient.

Exclusion Criteria:

* Presence of epileptiform activity on EEG.
* Previous history of epilepsy.
* Extensive hemorrhage or ischemia.
* Metallic clips or intracranial implants.
* Pacemaker e Baclofen infusion.
* Presence of drugs influencing arousal or awareness.

Primary outcomes:
measure: EEG coherence analysis
timeFrame: Change from baseline EEG coherence at the end of brain stimulation (two weeks)
Secondary outcomes:
measure: Disability Rating Scale
timeFrame: Change from baseline DRS scale at the end of brain stimulation (two weeks)
Other outcomes:
measure: Western Neuro Sensory Stimulation Profile (WNSSP)
timeFrame: Change from baseline WNSSP scale at the end of brain stimulation (two weeks)
Locations:
city: Venice
country: Italy
facility: IRCCS San Camillo Foundation
Study officials:
affiliation: San Camillo Foundation
name: Francesco Piccione, MD
role: STUDY_DIRECTOR
References:
citation: Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24.
citation: Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neural Repair. 2011 Jan;25(1):98-102. doi: 10.1177/1545968310369802. Epub 2010 Jul 20.
Clinical trial NCT01176123: Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
Official title: Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Cognitive behavioral therapy
Insomnia
Traumatic Stress
Lead sponsor: Southeast Louisiana Veterans Health Care System
Sponsor class: FED
Collaborators: name: VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC)
First posted: 2010-08-05
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. The objective of this study is to examine whether CBT-I will equivocally reduce problems falling and staying asleep (insomnia) related to military-related PTSD when administered in person versus through telephone therapy to veterans living in rural areas.

Rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. Thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia.

Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for trauma-related insomnia. Participants will be randomized to one of two treatment conditions: (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by telephone). No changes will be made to the CBT-I, other than mode of delivery, for the telemedicine group.

Through this study the investigators hope to demonstrate the effectiveness of CBT-I for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.


Eligibility criteria: Inclusion Criteria:

* Veterans living 30 or more miles from VA PTSD specialty services
* Diagnosis of PTSD or subthreshold PTSD symptoms
* Trauma-related insomnia

Exclusion Criteria:

* Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
* Psychosis
* Active alcohol dependence
* Active drug dependence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
Study officials:
affiliation: Southeast Louisiana Veterans Health Care System
name: Laurel Franklin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeast Louisiana Veterans Health Care System
name: Sheila Corrigan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532350: Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
pharmacokinetics
plethysmography
cycle ergometry
exercise testing
spirometry
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Patients between 40 and 80 years of age with controlled COPD.
* Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
* Body mass index (BMI) must be within the range of 18 to 32 kg/m2

Exclusion Criteria:

* Participation in any interventional clinical investigation with 4 weeks of study start
* Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
* Past medical personal or close family history of clinically significant ECG abnormalities
* Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
* A known hypersensitivity to the drug.
* History of immunocompromise, including a positive HIV test result.
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety

Primary outcomes:
measure: Forced expiratory volume in 1 second
timeFrame: Days 1 and 7
Secondary outcomes:
measure: Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
timeFrame: Days 1 and 7
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis investigative site
city: Mannheim
country: Germany
facility: Novartis Investigative site
city: Wiesbaden
country: Germany
facility: Novartis Investigative site
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: