louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01809977: Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus
Official title: Study of Surgical Methods for Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconus
Keywords: Keratoconus
remove
cornea
visual acuity
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which surgical method makes less corneal haze

Detailed description: Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.

Eligibility criteria: Inclusion Criteria:

* Age between 16-40 years
* axial topography consistent with keratoconus
* minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months

Exclusion Criteria:

* history of ocular herpes or non-healing corneal ulcers
* subjects with current ocular infection
* severe preoperative corneal haze or scar
* severe ocular surface disease
* autoimmune diseases
* pregnant women

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: at six months after surgery
Secondary outcomes:
measure: Corneal optical density
timeFrame: at six months after surgery
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Feyz university hospital
Study officials:
affiliation: MD, Departement of ophtalmology, Isfahan University of Medical Sciences, Isfahan, Iran
name: Behrooz Rahimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razmjoo H, Rahimi B, Kharraji M, Koosha N, Peyman A. Corneal haze and visual outcome after collagen crosslinking for keratoconus: A comparison between total epithelium off and partial epithelial removal methods. Adv Biomed Res. 2014 Nov 29;3:221. doi: 10.4103/2277-9175.145677. eCollection 2014.
Clinical trial NCT00656877: Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty
Official title: Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fat Embolism Syndrome
Keywords: Fat Embolism Total Knee Arthroplasty
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are deemed candidates for Computer Assisted Total Knee Arthroplasty

Brief summary: The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.

Detailed description: Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death.

Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced.

Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements.

This study is to presumed to show yet another benefit of computer assisted surgery.

Eligibility criteria: Inclusion Criteria:

* Must be a candidate for Computer Assisted Total Knee Arthroplasty

Exclusion Criteria:

* Mentally incompetent patients excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University School Of Medicine, Department of Orthopaedics
state: West Virginia
Study officials:
affiliation: Marshall University
name: Ali Oliashirazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573777: Reducing Intracranial atheroSclErosis With Repatha
Official title: Reducing Intracranial atheroSclErosis With Repatha
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Intracranial Atherosclerosis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2020-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to understand the underlying mechanism by which PCSK9 inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing atherosclerotic plaque, which would be particularly beneficial for patients with intracranial atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* History of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (American Heart Association definition).
* Large vessel atherosclerosis of an intracranial artery in the circle of Willis with 50-99% stenosis by WASID criteria (percent stenosis = (1-\[diameter stenosis/diameter normal\]) x 100%) on MRA, CTA or DSA

  ------ Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA, ACA (A1)
* Current statin use or contraindication to statin
* Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) \> 30 mg/ dL

Exclusion Criteria:

Gadolinium or PCSK9 inhibitor allergy

* Acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
* Pacemaker or other MRI contraindications per American College of Radiology guidelines
* Inability to return for 78 week follow-up clinic visit and vwMRI

Primary outcomes:
measure: Stenosis
timeFrame: 1.5 years
Secondary outcomes:
measure: Percent Atheroma Volume
timeFrame: 1.5 years
Other outcomes:
measure: Ischemic Stroke
timeFrame: 1.5 years
measure: ITA
timeFrame: 1.5 years
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
Clinical trial NCT02072577: Effect of Educational Video in the Student's Knowledge
Official title: Effect of Educational Video in the Student's Knowledge About Oral Hygiene of Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Students of Undergraduate School of Nursing
Keywords: Nursing care, oral health, educational video, oral hygiene.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Supervise dental conditions and teach the procedure of oral hygiene are the responsibility of the nurse. Patients on chemotherapy have risk for oral and systemic changes factors. The investigators will evaluate the cognitive and procedural knowledge about oral hygiene and the relevance of the learning experience importance.

Detailed description: METHODOLOGY:

-Quasi-experimental research study, before and after an intervention, which was used in the educational video as a strategy for teaching about oral hygiene .

INSTRUMENTS:

1 ) tool to identify socio- demographic variables ( age, gender ),

2) scale (zero to ten) to assess the relevance of the student attaches the oral hygiene of people undergoing chemotherapy ;

3 ) instrument composed of true or false statements related to knowledge about oral hygiene for people undergoing chemotherapy,

4) instrument contemplating steps that should be used for oral hygiene of the patient and the structures escovadas6 ; contains a list of steps to observation record the implementation of the technique of brushing teeth , use mouthwash and floss;

5 ) rating scale the degree of acceptance of the use of video as educativa.7 the student carried out the technical strategy in itself ( before and after video ) , demonstrating how a patient undergoing chemotherapy should perform this technique .

The estimate for the subject's participation in research time was approximately 30 minutes.

Eligibility criteria: Inclusion Criteria:

-Students in the fourth year of the Bachelor and the fifth year of undergraduate School of Nursing of Ribeirão Preto, University of São Paulo - USP

Exclusion Criteria:

-Desire to withdraw consent for the study procedures

Primary outcomes:
measure: Knowledge
timeFrame: In 30 minutes of the study (video and technique after and before that)
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Emilia Carvalho, Full professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02639377: Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
Official title: Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Gingivitis
Keywords: Dental Implantation
Chlorhexidine gluconate
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month follow-up.

Detailed description: The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant and teeth (VPI implant; VPI teeth; GBI implant; GBI teeth). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.

Probing depth (PD implant; PD teeth) and bleeding on probing (BOP implant; BOP teeth) were collected for all implants and teeth with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing and probing depths were calculated at baseline, three and six months. The peri-implant and periodontal biotype for each implant and teeth was rated as thin or thick, according to probe transparency during probing depth.

Eligibility criteria: Inclusion Criteria:

* Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
* Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant;
* Patients had been diagnosed with gingivitis in homologous teeth to implants.

Exclusion Criteria:

* Non-smokers and not in maintenance therapy;
* Periodontal treatment during the last six months;
* Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.

Primary outcomes:
measure: Bleeding on probing
timeFrame: baseline
measure: Bleeding on probing
timeFrame: three months
measure: Bleeding on probing
timeFrame: six months
Secondary outcomes:
measure: Probing depth
timeFrame: baseline and at three and six months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Bruno CV Gurgel, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01729377: The Meaning of Suicidality for Older Persons With Suicidal Tendencies and Their Families
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide
Aged
Family
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-20
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged individuals from tertiary and primary care and from the community who have experienced suicidality and their families.

Brief summary: The purpose of the proposed study is to examine the phenomenon of suicidality in old age and its unique characteristics. This will be performed through observing the multigenerational aging family from the life-course perspective, which enables the researchers to address life transitions, including crises leading to suicidal tendencies.


Eligibility criteria: Inclusion Criteria:

* Hebrew speaking
* Suicidal
* Families of elderly suicides
* Cognitive ability

Exclusion Criteria:

* All others

Primary outcomes:
measure: Understanding older persons experiencing suicidality and their families
timeFrame: One and a half hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00270777: Improving Safety of Antivenom in People Bitten by Snakes
Official title: Low Dose Adrenaline, Promethazine, & Hydrocortisone (Alone and in Combination) to Prevent Acute Adverse Reactions to Antivenom in People Bitten by Snakes: Randomised, Double Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Snake Bites
Keywords: Controlled trial
Snake bite
Safety
Antivenom
Lead sponsor: University of Kelaniya
Sponsor class: OTHER
First posted: 2005-12-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, \& hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.


Eligibility criteria: Inclusion Criteria:

* Above 12 years of age
* Patients admitted to hospital after snake bite in whom antivenom is indicated
* Patients who give informed consent

Exclusion Criteria:

* Patients who are pregnant or nursing
* Patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants
* Patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)

Primary outcomes:
measure: Frequency of severe reactions to antivenom in the first 48 hours
Secondary outcomes:
measure: Frequency of moderate & severe reactions to antivenom in the first 48 hours
Other outcomes:
Locations:
city: Ragama
country: Sri Lanka
facility: Clinical Trials Unit, University of Kelaniya
Study officials:
affiliation: University of Kelaniya
name: Asita de Silva
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Silva HA, Pathmeswaran A, Ranasinha CD, Jayamanne S, Samarakoon SB, Hittharage A, Kalupahana R, Ratnatilaka GA, Uluwatthage W, Aronson JK, Armitage JM, Lalloo DG, de Silva HJ. Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 May;8(5):e1000435. doi: 10.1371/journal.pmed.1000435. Epub 2011 May 10.
Clinical trial NCT02051777: Hospital Discharge Oral Nutrition Support Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To investigate the effect of different strategies for managing malnutrition in the community


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Age 50 years and over
* Able to eat and drink without the need for altered texture fluids
* Identified at risk of disease related malnutrition
* Competent to provide written informed consent
* Willingness to take part in the study and to follow the study protocol

Exclusion Criteria:

* Individuals unable to eat or drink
* Chronic renal disease requiring dialysis
* Galactosaemia
* Dysphagia
* Normally or going to be residing in an institution e.g. care home upon discharge from hospital
* Palliative care
* Cancer (active treatment)
* Liver failure
* Poorly controlled diabetes
* Diagnosed lactose intolerance
* Participation in other clinical trials currently or in the previous 4 weeks
* Due to be discharged to an area out of the hospital region
* Requiring tube or parenteral nutrition
* Due to be discharged from hospital on oral nutrition support recommended by a Dietitian

Primary outcomes:
measure: Nutrient Intake
timeFrame: 12 weeks (8 week intervention followed by 4 week follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Nutricia Ltd
Study officials:
References:
Clinical trial NCT00399477: A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
Official title: Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:

* Group 1 Patients using Azilect and no other therapy.
* Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.


Eligibility criteria: Inclusion Criteria:

1. Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
2. Requiring therapy for PD symptom control

   * Azilect monotherapy.
   * Azilect as adjunct therapy..

Exclusion Criteria:

1. Patients previously exposed to Azilect
2. Patients with pheochromocytoma
3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Primary outcomes:
measure: To identify the earliest scheduled visit of symptomatic effect
timeFrame: 8 months
Secondary outcomes:
measure: To characterize the effectiveness of Azilect in a usual community neurological
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: MerriKay Oleen-Burkey, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03078777: The Effect Dialysis on the Pharmacokinetics of Fexofenadine
Official title: The Effect Dialysis on the Pharmacokinetics of Fexofenadine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodialysis
Keywords: Pharmacokinetics
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The Investigators recently completed and published a study that demonstrated that fexofenadine pharmacokinetics are significantly altered in dialysis patients (Thomson et al. (2015) American Journal of Kidney Diseases 65(4):574-582). In this study, patients were studied directly before routine dialysis treatment. Other published literature suggests the timing of the dose of some drugs (before or after dialysis) may have a profound impact on the drug pharmacokinetics (Nolin et al (2006) 17(9):2363-7). The hypothesis is that compounds that accumulate in the blood of patients with kidney failure impact the pharmacokinetics such that dosing before or after dialysis produces significantly different blood levels of the drug.

Detailed description: This will be an open, randomized pharmacokinetic study in 30 patients treated by dialysis. Patients will be asked to spend an additional 3 hours at the hospital on each of two study days separated by at least a week. At the first study visit, the patient will be randomized to receive the drug fexofenadine (120 mg, orally) either 3 hour prior to, OR at the conclusion of their regularly scheduled dialysis treatment. Three hours following fexofenadine administration, a single 4 mL (approximately 1 teaspoon) blood sample will be drawn. One week or more after the first study day, the patient will have the study repeated but with the timing of the dose altered to match the randomization. For example, if at the first study visit the patient received fexofenadine after their dialysis session, they will now receive the drug 3 hours prior to their dialysis session. The blood sample will be centrifuged immediately and plasma stored at -80 celsius until analysis. Fexofenadine concentration will be determine by liquid chromatography coupled to mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Patients treated by any dialysis modality (e.g. hemodialysis, peritoneal dialysis) for at least 90 days prior to study enrolment.

Exclusion Criteria:

* Current or recent (within two weeks) hepatic or gastrointestinal morbidity. Inability or refusal to provide written informed consent. Unable to provide a blood sample. Female patients that are pregnant will be excluded.

Primary outcomes:
measure: Plasma Fexofenadine Concentration
timeFrame: 3 hours following dosing
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: