louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00421005: Fluvastatin After Heart Transplantation
Official title: Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Transplantation
Hypercholesterolemia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.


Eligibility criteria: Inclusion Criteria:

* De novo heart transplantation

Exclusion Criteria:

* Known allergy/intolerance to fluvastatin;
* Preexisting neuromuscular disorders;
* Significant liver disease and/or elevation of transaminase exceeding 3 times the ULN
* Severe renal impairment : creatinine \> 3 mg/dL
* Intellectual/cognitive impairment likely to compromise informed consent or adherence to protocol or age \<18 years.
* Patients refusal
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
Study officials:
affiliation: Alma Mater Studiorum University of Bologna
name: Angelo Branzi, MD
role: STUDY_CHAIR
References:
citation: Kobashigawa JA, Katznelson S, Laks H, Johnson JA, Yeatman L, Wang XM, Chia D, Terasaki PI, Sabad A, Cogert GA, et al. Effect of pravastatin on outcomes after cardiac transplantation. N Engl J Med. 1995 Sep 7;333(10):621-7. doi: 10.1056/NEJM199509073331003.
citation: Holdaas H, Fellstrom B, Cole E, Nyberg G, Olsson AG, Pedersen TR, Madsen S, Gronhagen-Riska C, Neumayer HH, Maes B, Ambuhl P, Hartmann A, Staffler B, Jardine AG; Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators. Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin: the ALERT extension study. Am J Transplant. 2005 Dec;5(12):2929-36. doi: 10.1111/j.1600-6143.2005.01105.x.
citation: Grigioni F, Carigi S, Potena L, Fabbri F, Russo A, Musuraca AC, Coccolo F, Magnani G, Ortolani P, Leone O, Arpesella G, Magelli C, Branzi A. Long-term safety and effectiveness of statins for heart transplant recipients in routine clinical practice. Transplant Proc. 2006 Jun;38(5):1507-10. doi: 10.1016/j.transproceed.2006.02.071.
Clinical trial NCT00986505: Intravenous Lidocaine for Fibromyalgia
Official title: Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: lidocaine
fibromyalgia
intravenous lidocaine
manifestations
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.

Detailed description: Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded: sleep disorders, fatigue, subjective edema, depression, and paresthesia.

Criteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy; other pain syndromes; drug hypersensitivity, and pregnancy.

All patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of group 2 (n = 15) received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).

Eligibility criteria: Inclusion Criteria:

* 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points

Exclusion Criteria:

* Thyroid, rheumatological, renal and hepatic function
* Trauma
* Rheumatic, neuromuscular or psychiatric disease
* Infectious arthropathy
* Other pain syndromes
* Drug hypersensitivity; AND
* Pregnancy

Primary outcomes:
measure: pain
timeFrame: 1day
Secondary outcomes:
measure: other signs
timeFrame: 1day
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02316405: Can Arm and Leg Cycling Exercise Improve Walking After Stroke
Official title: Can Arm and Leg Cycling Exercise Improve Walking After Stroke?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: It has been found that arm and leg cycling is similar to walking. Thus, the objective of this research is to determine if arm and leg cycling can be used to improve walking ability in a post-stroke population. This outcome would directly impact the health and quality of life for those who have suffered a stroke.

Detailed description: It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns, joint ranges of motion, and neural pathways activated. Another advantage of arm and leg cycling is that it involves coordination of all four limbs in a rhythmic movement. This may be particularly beneficial given previous findings that arm movement contributes to the activation of leg muscles during walking in humans. This is achieved with interconnected neural pathways that link the arms to the legs. These neural interlimb connections remain intact in stroke victims, such that maximizing the contribution of the arms to the legs may increase coordination for walking.

Thus, the objective of this research is to determine if arm and leg cycling can be used to increase the strength of inter-limb connections and if this helps to improve walking ability in a post-stroke population. 15-20 participants will be recruited to participate in a five week training intervention where measures will be taken before and after the intervention to assess efficacy. Arm and leg cycling could provide a novel method to improve inter-limb coupling and walking ability. These outcomes would directly impact the health and quality of life for those who have suffered a stroke.

Eligibility criteria: Inclusion Criteria:

* Cerebrovascular accident

Exclusion Criteria:

* Inability to stand

Primary outcomes:
measure: Walking Ability
timeFrame: Within five days
Secondary outcomes:
measure: Clinical Status assessed by a Physiotherapist
timeFrame: Within 5 days
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: MacLaurin Building
state: British Columbia
Study officials:
affiliation: University of Victoria
name: E P Zehr, Doctorate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276805: Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
Official title: Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2020-02-19
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).


Eligibility criteria: Inclusion Criteria:

* Healthy individuals willing to commit to study requirements

Exclusion Criteria:

* Neurological disorders to include traumatic brain injury.
* Evidence of dementia .
* Major psychiatric illness
* Unstable and chronic medical conditions.
* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
* Physical impairment precluding motor response or lying still or walking
* Hearing or vision deficits that will not allow for completion of assessments

Primary outcomes:
measure: Change in working memory and processing speed contributors
timeFrame: Baseline to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: John Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924105: Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes
Official title: A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization
* HbA1c in the range of 6.5 - 9.5% (inclusive) at screening
* Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization
* Further criteria as defined in the clinical trial protocol

Exclusion Criteria:

* Symptoms of hyperglycemia (i.e. polyuria and polydypsia)
* History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization
* Fasting C-peptide level \< 400 pmol/L at screening
* Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization
* Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
* Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids

Primary outcomes:
measure: Incidence of adverse events
timeFrame: continously
Secondary outcomes:
measure: Biological measures of glycemia and inflammation
timeFrame: continously
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Cytos Investigator sites
city: Basel
country: Switzerland
facility: Cytos Investigator sites
city: Zuerich
country: Switzerland
facility: Cytos Investigator sites
Study officials:
References:
citation: Cavelti-Weder C, Timper K, Seelig E, Keller C, Osranek M, Lassing U, Spohn G, Maurer P, Muller P, Jennings GT, Willers J, Saudan P, Donath MY, Bachmann MF. Development of an Interleukin-1beta Vaccine in Patients with Type 2 Diabetes. Mol Ther. 2016 May;24(5):1003-12. doi: 10.1038/mt.2015.227. Epub 2015 Dec 21.
Clinical trial NCT03125005: Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria

* The subject is male or female, aged ≥18 and \<50.
* The subject is in good general health with no evidence of any medical problems.
* The subject is fluent in both written and spoken English.
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* The subject is obese (BMI\>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject has a history of migraine headaches.
* The subject is currently taking antidepressants.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
city: San Francisco
country: United States
facility: University of San Francisco
state: California
Study officials:
References:
Clinical trial NCT01718405: Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Executive Function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.


Eligibility criteria: Inclusion Criteria:

* Physical Education Students
* Able to sign consent form

Exclusion Criteria:

* Competitive athletes
* Smokers
* Neurologic or psychologic orders
* Chronic diseases
* Head Injuries
* Hospitalization in the previous 3 months
* Pregnant

Primary outcomes:
measure: Cognitive Functioning After Exercise
timeFrame: Five minutes
Secondary outcomes:
Other outcomes:
measure: Genetic Variation Associated with Different Cognitive Functioning
timeFrame: Two years
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
Clinical trial NCT00853905: Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
Official title: The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glaucoma
Keywords: open angle glaucoma (POAG)
angle closure glaucoma (PACG)
pigmentary glaucoma
pseudoexfoliation glaucoma
neovascular glaucoma
traumatic glaucoma
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2009-03-02
Enrollment: 77
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Detailed description: Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.

Eligibility criteria: Inclusion Criteria:

* glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
* primary open angle glaucoma
* primary angle-closure glaucoma
* pseudoexfoliation glaucoma
* pigmentary glaucoma
* traumatic glaucoma
* neovascular glaucoma

Exclusion Criteria:

* patients that are pregnant, nursing, or not using adequate contraception
* any other eye surgery except cataract surgery
* an infection, inflammation, or any abnormality preventing measurement of eye pressure
* enrolled in another investigational study

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits
Secondary outcomes:
measure: Anterior Chamber Inflammation (Flare)
timeFrame: 1 month, 3 month and 6 month post-op visits
measure: Bleb Appearance
timeFrame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
measure: Patient Comfort
timeFrame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
measure: Ocular Hypotensive Medications
timeFrame: 1 week, 1 month, 3 month, and or 6 month post-op visits
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: Marlene R Moster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.
Clinical trial NCT01489605: GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study
Official title: Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intubation, Orotracheal
Keywords: Orotracheal intubation, videolaryngoscopy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2011-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.

Detailed description: See above. The primary outcome is time to intubation.

Eligibility criteria: Inclusion Criteria:

* Any adult patient booked for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

1. Any patient with cervical spine abnormalities.
2. Any patients with known or probable difficult airways.
3. Any patient requiring rapid sequence induction.

Primary outcomes:
measure: Duration of Intubation
timeFrame: Day 1
Secondary outcomes:
measure: Ease of intubation
timeFrame: Day 1
measure: Incidence of trauma
timeFrame: Day 1
measure: Number of failures to intubate
timeFrame: Day 1
measure: Use of external laryngeal pressure
timeFrame: Day 1
measure: Laryngoscopic grade distribution
timeFrame: Day 1
measure: Sore Throat
timeFrame: Day 3
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center University Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre Victoria Campus
state: Ontario
Study officials:
affiliation: UWO
name: Timothy Turkstra, MD, M. Eng
role: PRINCIPAL_INVESTIGATOR
References: