louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02330172: Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.
Official title: Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.

Detailed description: This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia

Exclusion Criteria:

* BMI \>25 or \< 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase \> 40 IU/L, Cr \> 1.4 mg/dl

Primary outcomes:
measure: Laryngoscopic Score
timeFrame: At the beginning of surgery, the surgeon rated the laryngoscopy condition
Secondary outcomes:
measure: Recovery Time From Neuromuscular Blockade
timeFrame: from the injection of neostigmine or sugammadex up to 30 minutes
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Eunsu Choi
state: Gyeonggi-do
Study officials:
affiliation: Bungdang Seoul National University
name: Ah Young Oh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi ES, Oh AY, Koo BW, Hwang JW, Han JW, Seo KS, Ahn SH, Jeong WJ. Comparison of reversal with neostigmine of low-dose rocuronium vs. reversal with sugammadex of high-dose rocuronium for a short procedure. Anaesthesia. 2017 Oct;72(10):1185-1190. doi: 10.1111/anae.13894. Epub 2017 May 11.
Clinical trial NCT05955872: A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
Official title: A Phase 1, Open Label, Randomized, Crossover Study Evaluating the Relative Bioavailability and Food Effect of a VX-147 Test Tablet Formulation Compared to a Reference Tablet Formulation in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focal Segmental Glomerulosclerosis (FSGS)
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 21
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 the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2), inclusive
* A total body weight greater than 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
timeFrame: From Day 1 up to Day 16
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference
timeFrame: From Day 1 up to Day 16
measure: Cmax of VX-147 Test Compared Under Fed Versus Fasted State
timeFrame: From Day 1 up to Day 16
measure: AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State
timeFrame: From Day 1 up to Day 16
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: From Day -1 up to Day 27
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT01845272: Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
Official title: Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 40
Sex: MALE
Minimum age (years): 20
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 designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old(inclusive)
* Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
* Available for the entire study period
* Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
* Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
* Subject with symptoms of acute disease within 14days prior to study medication dosing
* Subjects with a history of clinically significant allergies
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.5 times to normal range or total bilirubin \> 1.5times to normal range)
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee,tea,coke) or grapefruit juice \> 4cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140g/week
* Positive test results for HBs Ab, HCV Ab, Syphilis regain test
* Participation in any clinical investigation within 30days prior to study medication dosing
* Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
* Subjects considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: Assessment of the drug-drug interactions of candesartan and amlodipine
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Jae-wook Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01941472: Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Shock
Fluid Challenge
Fluid Responsiveness
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.


Eligibility criteria: Inclusion Criteria:

* 18 years and older ICU patients;
* Septic shock;
* Monitored with PICCO or Swan-Ganz catheter;
* The decision of fluid challenge made by the treating physician;

Exclusion Criteria:

* Evidence of fluid overload;
* Pregnancy

Primary outcomes:
measure: Fluid Responsiveness
timeFrame: Immediately after fluid challenge, average 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: MICU of Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Liu G, Huang H, Qin H, Du B. [Predictive value of central venous-to-arterial carbon dioxide partial pressure difference for fluid responsiveness in septic shock patients: a prospective clinical study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 May;30(5):449-455. doi: 10.3760/cma.j.issn.2095-4352.2018.05.011. Chinese.
citation: Xu B, Yang X, Wang C, Jiang W, Weng L, Hu X, Peng J, Du B. Changes of central venous oxygen saturation define fluid responsiveness in patients with septic shock: A prospective observational study. J Crit Care. 2017 Apr;38:13-19. doi: 10.1016/j.jcrc.2016.09.030. Epub 2016 Oct 19.
Clinical trial NCT02766972: Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
Official title: Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Surgical Clip
Keywords: Intracranial Aneurysm
Surgical Clipping
Rapid Ventricular Pacing
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study.

Detailed description: Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study. Patients with complex UIA were prospectively enrolled and the safety and efficacy of RVP were evaluated recording cardiovascular events and outcome of the patients as well as the amount of aneurysm occlusion after the surgical clip-reconstruction procedure.

Eligibility criteria: Inclusion Criteria:

* complex UIA intended to be treated by microsurgical clip-reconstruction
* application of RVP intra-operatively

Exclusion Criteria:

* structural heart disease or conductance abnormalities

Primary outcomes:
measure: modified Rankin scale
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of flow reduction and improvement of clip application
timeFrame: intraoperatively
measure: safety of pacing catheter
timeFrame: intraoperatively upt o 24 hours after operation
measure: Cardiovascular events
timeFrame: intraoperatively upt o 24 hours after operation
measure: occlusion rate of aneurysm
timeFrame: 1 week after operation
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Goethe University Hospital
Study officials:
References:
citation: Konczalla J, Platz J, Fichtlscherer S, Mutlak H, Strouhal U, Seifert V. Rapid ventricular pacing for clip reconstruction of complex unruptured intracranial aneurysms: results of an interdisciplinary prospective trial. J Neurosurg. 2018 Jun;128(6):1741-1752. doi: 10.3171/2016.11.JNS161420. Epub 2017 Aug 18.
Clinical trial NCT02371772: Self-management of Anticoagulation Treatment
Official title: Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-term Oral Anticoagulant Therapy
Keywords: Warfarin
Self Care
Conventional care
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Detailed description: Patients (n=23) on anticoagulant treatment with warfarin participated in a 27 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek® XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for 28 weeks. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. Ten INR values and complications before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after 28 weeks of self-management.

Eligibility criteria: Inclusion Criteria:

* on life-long oral anticoagulation therapy
* Live in Bergen municipality
* Judged to be qualified for patient self-management anticoagulation treatment by their GP
* Motivated to follow the training program

Exclusion Criteria:

* Drug abuse
* Liver disease

Primary outcomes:
measure: Change in Time in therapeutic range (TTR)
timeFrame: From 39 weeks before enrolment until 28 weeks of self management
Secondary outcomes:
measure: Change in number of complications
timeFrame: From 39 weeks before enrolment until 28 weeks of self management
Other outcomes:
Locations:
Study officials:
affiliation: University of Bergen
name: Una Ø Sølvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681772: Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
Official title: Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-05-21
Enrollment: 333
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age,
* ED 6 months or longer
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: International Index of Erectile Function - Erectile Function Domain
timeFrame: 12 weeks
Secondary outcomes:
measure: Sexual Encounter Profile Question 2 and 3
timeFrame: 12 weeks
measure: Global Assessment Question
timeFrame: 12 weeks
measure: Other diary based variables
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03137472: TMS for Complex Regional Pain Syndrome
Official title: Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: TMS, CRPS, Sham
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Redlich Pain Endowment
name: Rocky Mountain Foundation
name: The Feldman Family Foundation Pain Research Fund
First posted: 2017-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.


Eligibility criteria: Inclusion Criteria:

* Age 18-70
* Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
* Average pain level reported on Numerical Rating Scale meets entry criteria
* Ability to perform the experimental task and procedures.

Exclusion Criteria:

* MRI contraindication (metal implants or devices, claustrophobia)
* TMS Contraindication (eg metal implant or devices near the site of stimulation)
* History of epilepsy
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.

Primary outcomes:
measure: Change in Pain
timeFrame: 1 week follow-up compared to baseline
measure: Duration of Pain Relief
timeFrame: Duration from last treatment until pain returns - up to an estimate of 6 months
Secondary outcomes:
measure: Change in Pain-related Symptomology
timeFrame: Duration from last treatment until pain returns - up to an estimate of 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Pain Management Center
state: California
Study officials:
References:
Clinical trial NCT00013572: HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
Official title: A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: Injections, Intramuscular
Injections, Intradermal
Injections, Subcutaneous
HIV-1
AIDS Vaccines
Dendritic Cells
HIV Seronegativity
Genes, env
Genes, pol
Genes, gag
Transfection
HIV Preventive Vaccine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Detailed description: Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

Eligibility criteria: Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are legal US residents.
* Are healthy adults from 18 to 55 years of age.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Are HIV-positive.
* Are at highest risk for HIV infection.
* Are pregnant or breast-feeding.
* Are allergic to eggs or neomycin.
* Use certain prescription medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Walter Reed Army Institute of Research (WRAIR)
state: Maryland
Study officials:
name: Mary Marovich
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.