louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00713336: Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
Official title: A Phase I, Double-blind, Double-dummy, Placebo-controlled, Randomised, Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ZD4054
Healthy Volunteers
QT interval
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer


Eligibility criteria: Inclusion Criteria:

* Non Smoker
* Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
* Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion Criteria:

* Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
* Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
* Judgement by the investigator, that the healthy volunteer should not participate in the study

Primary outcomes:
measure: to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
timeFrame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Secondary outcomes:
measure: assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
timeFrame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
measure: assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.
timeFrame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
measure: further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.
timeFrame: From time of Consent to Last Follow-up Visit
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG
name: Raj Chetty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01411436: Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
Official title: Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Nexavar
unresectable hepatocellular carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 1637
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who received Nexavar for unresectable HCC.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
timeFrame: After Nexavar administration, up to 1 year
Secondary outcomes:
measure: Demography
timeFrame: Baseline
measure: Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)
timeFrame: After Nexavar administration, up to 1 year
measure: Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response
timeFrame: After Nexavar administration, up to 1 year
measure: The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS]
timeFrame: After Nexavar administration, up to 1 year
Other outcomes:
Locations:
city: Many locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kaneko S, Ikeda K, Matsuzaki Y, Furuse J, Minami H, Okayama Y, Sunaya T, Ito Y, Inuyama L, Okita K. Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study. J Gastroenterol. 2016 Oct;51(10):1011-21. doi: 10.1007/s00535-016-1173-5. Epub 2016 Mar 1.
Clinical trial NCT00881036: Activation of Hepatitis B Virus (HBV) in Hepatitis B Surface Antigen (HBsAg) - Negative But Hepatitis B Core Antibody (Anti-HBc) - Positive Patients
Official title: Activation of HBV Under Immunosuppression in HBsAg-negative But Anti-HBc-positive Patients With Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Hepatitis B
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 33
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: HBsAg-negative but anti-HBc-positive patients with hematological malignancies treated at Kyoto University Hospital

Brief summary: Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis B has not been well established. Risk factors and effective management for de novo hepatitis B will be clarified.


Eligibility criteria: Inclusion Criteria:

* HBsAg-negative but anti-HBc-positive

Exclusion Criteria:

* Serum HBV DNA-negative

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto Univesity
Study officials:
References:
Clinical trial NCT06710236: Evaluation of Investigational Hearing Instrument Features
Official title: Evaluation of Investigational Hearing Instrument Features
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:

How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?

Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.


Eligibility criteria: Inclusion Criteria:

* Adult, age 18 - 95 years
* N4 hearing loss
* Experienced hearing aid user
* English fluency
* Cognitively able to complete complex listening tasks

Exclusion Criteria:

* Normal hearing, or hearing loss outside the specified range
* No hearing aid experience
* Unable to speak, read, or write English fluently
* Cognitive impairment
* Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator

Primary outcomes:
measure: Hearing instrument feature performance
timeFrame: From enrollment to the completion of data collection, approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT00474136: Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium
Official title: Open-Label, Randomized, Single Center Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses) Versus Oral Diclofenac Potassium in Healthy Adult Volunteers Following Single- and Multiple-Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-16
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: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Detailed description: This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 55 years of age.

Exclusion Criteria:

* Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
* Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs.
* History of previous and/or present peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or for HIV antibodies, or history of asthma.

Primary outcomes:
measure: To assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.
timeFrame: Several time points over 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: PAREXEL International
state: Maryland
Study officials:
affiliation: Parexel
name: Terri Lunsford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02599636: To Survive After ICU Discharge
Official title: Multicenter Prospective Study: To Survive After ICU Discharge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: In-Hospital Mortality
Number of ICU Readmission
Number of Warnings On-duty
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at ICU discharge

Brief summary: Many factors before and after ICU stay determine the outcome of patients at ICU discharge, the type of illness, physical dependence and other sequelae can be a trigger for complications in hospital ward which can induce ICU readmission and worse outcome. The quality of medical assistance during all the hospitalisation should be guaranteed and many complications or fatal events could be avoidable.

The objective of the present study is to demonstrate that collaboration between the intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality after ICU discharge.

Detailed description: Material and Methods This observational multicenter study will be done in 21 medical-surgical ICUs. We will use Sabadell Score like prognostic scale at ICU discharge and the intensivist will collaborate with the medical team in medical assistance of patients at risk (Sabadell Score 1 and 2). Investigators will compare the hospital mortality and the readmission rate with a previous period when this collaboration didn't exist.

Anticipate results The collaboration of attending intensivist might reduce ward mortality after ICU discharge by 3%.

Eligibility criteria: Inclusion Criteria:

* All patients with Sabadell Score 1 (poor prognosis in long term) and 2 (poor prognosis in short term) at ICU discharge

Exclusion Criteria:

* patients younger than 18 years old
* patients with Sabadell Score 0 (good prognosis)
* patients with Sabadell Score 3 (null expected survival)
* patients transferred to other hospitals

Primary outcomes:
measure: The decline in hospital mortality
timeFrame: 3 months
Secondary outcomes:
measure: The decline in number of warnings on-duty
timeFrame: 3 months
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitaria de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitaria de Manresa
name: Silvia Cano Hernández, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468336: AngioDefender Versus Brachial Artery Ultrasound Imaging
Official title: Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Physiology
Lead sponsor: Everist Genomics, Inc
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.


Eligibility criteria: Inclusion Criteria:

* ECOG 0-2

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>40 cm
3. Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting tremor or inability to remain still for the duration of AD and BAUI testing
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Primary outcomes:
measure: Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of types and incidences of emergent adverse device effects
timeFrame: 1 day
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado, Boulder
state: Colorado
city: Derby
country: United States
facility: Yale University Prevention Research Center
state: Connecticut
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: Everist Health
name: Peter F Lenehan, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05607836: IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest
Official title: A Pilot, Prospective, Randomized Trial of IntuBrite Versus Macintosh Direct Laryngoscopy for Paramedic Endotracheal Intubation in Out of Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Cardiopulmonary Arrest
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: a randomized, parallel, non-blinded trial in a single Emergency Mdeical Service in Poland within a group of 34 ground ambulances crews, comparing time and first pass success (FPS) for endotracheal intubation (ETI) in DL using the IntuBrite® (INT) and Macintosh laryngoscope (MCL) during cardiopulmonary resuscitation (CPR). intubations will be performed using INT and MCL based on an intention-to-treat analysis. The FPS time of the ETI attempt will be analysed. First attempt success will be counted.

Detailed description: Investigators designed a prospective observational study to compare INT (IntuBrite®, LLC; Vista, CA, USA) and MCL for ETI performed by paramedics in OHCA without an emergency physician on the scene. The main goal was to determine whether INT is superior to using an MCL laryngoscope during a tracheal intubation attempt in nontraumatic OHCA, in terms of time and effectiveness.

The time of intubation was measured using an electronic stopwatch. Time measurement began when the paramedic held the selected laryngoscope and declared their readiness to perform the procedure.

The effectiveness of the first ETI attempt for instrumental airway management for nontraumatic adult OHCA and end-tidal carbon dioxide monitoring was used to confirm correct device placement in all patients.

The degree difficulty of intubation attempts for all of the patients included in the study. A long-term survival and a cost-effectiveness analysis were not included within this trial.

The investigators will collect case report forms (CRFs) from patients after OHCA within a 40-month period.

The average professional experience of the paramedics in instrumental airway management will be noted (DL and LMA). The primary outcome is the FPS time of the ETI attempt performed by the paramedics.

The success rate on the first intubation attempt will be counted.

Eligibility criteria: Inclusion Criteria:

* patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion Criteria:

* suspected difficult intubation

Primary outcomes:
measure: Intubation time
timeFrame: 1 minute
Secondary outcomes:
measure: Intubation success
timeFrame: 1 minute
measure: intubation complications
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical University of Lodz, Poland
Study officials:
affiliation: Medical University of Lodz, Poland
name: Tomasz Gaszynski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448741: Complete Penile and Testicular Self-amputation: a Very Rare Case
Official title: Complete Penile and Testicular Self-amputation: a Very Rare Case
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Focus of Study is Description of a Very Rare Case
Lead sponsor: Worabe Comprehensive Specialiazed Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-07
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we studied a single person with unique case

Brief summary: The study is a case report on penile and testicular self-amputation. We didn't assign a drug of intervention. We tried to describe about this rare phenomenon by observation of the presentation and outcome.

Detailed description: We describe a very rare case of bilateral testicular and penile self-amputation by a psychiatric patient who came to our hospital after he amputated his penis and both of his testis. He was operated to replant his severed organs, but because of multiple reasons the replantation failed after 9 days of surgery. This kind of case is very rare, and it is our aim to disseminate the information about the case to physicians for better management in the future.

Eligibility criteria: Inclusion Criteria: Patient with Penile and testicular self-amputation -

Exclusion Criteria: Patients with out Penile and testicular self-amputation

-

Primary outcomes:
measure: Replantation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Worabe
country: Ethiopia
facility: Worabe Comprehensive Specialized Hospital
Study officials:
References: