louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01502657: Ultrasound Guided Percutaneous Tracheostomy
Official title: Ultrasound Guided Percutaneous Tracheostomy in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Hemorrhage
Tracheostomy Complications
Other Tracheostomy Complications
Keywords: percutaneous tracheostomy
ultrasonography
echography
critical care
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-01-02
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

Detailed description: Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized in ICU in whom percutaneous tracheostomy is indicated,
* patients aged \> 18 years old,

Exclusion Criteria:

* age less than 18 years,
* clotting disorder,
* infection at the puncture site,
* emergency tracheostomy

Primary outcomes:
measure: Procedure related complications
timeFrame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes:
measure: Procedure time
timeFrame: The time will be calculated at the end of the procedure; an average of 30 minutes
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Somme
Study officials:
affiliation: Centre Hospitalier Universitaire, Amiens
name: Pierre grégoire Guinot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.
Clinical trial NCT05605457: Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial
Official title: Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class V Dental Caries
Keywords: PRG barrier coat
nanohybrid resin composite
Resin modified glass ionomer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Detailed description: Class V carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat.Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Eligibility criteria: Inclusion Criteria:

* 18-60 years Males or females. Patients with untreated cervical carious lesion that need restoration. Participants available for recall Patients with moderate to high caries risk

Teeth Inclusion Criteria No spontaneous pain Absence of tooth mobility

Exclusion Criteria:

* Patients with para-functional habits Experience with allergic reactions against any component of used materials. Teeth Exclusion Criteria Non-vital teeth Teeth with orthodontic appliance Teeth with advanced periodontal diseases.

Primary outcomes:
measure: Modified USPHS criteria
timeFrame: 18 months
Secondary outcomes:
measure: Modified USPHS criteria
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01315457: Infections Associated With the Use of Alemtuzumab
Official title: Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Treated With Alemtuzumab
Keywords: alemtuzumab, infection, prophylaxis, treatment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Dr Cipto Mangunkusumo General Hospital
name: Asan Medical Center
name: Soon Chun Hyang University
name: Chonnam National University
name: Chonbuk National University
name: Chulalongkorn University
name: Queen Mary Hospital, Hong Kong
name: Yonsei University
name: Kyungpook National University Hospital
First posted: 2011-03-15
Enrollment: 182
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients received alemtuzumab as a treatment for hematologic malignancy

Brief summary: The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab


Eligibility criteria: Inclusion Criteria:

* Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia

Exclusion Criteria:

* Patients did not receive alemtuzumab

Primary outcomes:
measure: Infectious event
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Teipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257957: Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Official title: Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Sjogren Syndrome
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Detailed description: Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Eligibility criteria: Inclusion Criteria:

* • Patients with symptomatic Dry eye

  * Shirmer ≤10 mm in 5 min
  * BUT ≤10 seconds
  * Corneal staining ≥3
  * Age range: 18 years and older.
  * Both genders and all ethnic groups comparable with the local community.
  * Able to understand and willing to sign a written informed consent
  * Able and willing to cooperate with the investigational plan.
  * Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

  * Children under 18.
  * Pregnant women or expecting to be pregnant during the study.
  * Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  * Concomitant use of systemic antibiotics or steroids.
  * Contact lens wear
  * Active ocular infection or allergy
  * Unable to close eyes or uncontrolled blinking

Primary outcomes:
measure: Change From Baseline in Ocular Surface Staining
timeFrame: 90 days
measure: Change From Baseline in Shirmer Test
timeFrame: 90 days
Secondary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI)
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: Avila MY, Igua AM, Mora AM. Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye. Br J Ophthalmol. 2018 Jul 3:bjophthalmol-2018-312072. doi: 10.1136/bjophthalmol-2018-312072. Online ahead of print.
Clinical trial NCT01256957: Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health
Official title: Assessing the Impact of Wood Stove Interventions on Air Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Oxidative Stress
Systemic Inflammation
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Health Canada
name: Ministry of Environment, British Columbia
First posted: 2010-12-09
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.

Detailed description: The investigators will use portable HEPA filters in a single-blind randomized crossover design. Each participant's home will be monitored for two consecutive seven-day periods, during which time two HEPA units (one in the bedroom and one in the main living room) will be operated indoors. During one 7-day period the HEPA filters will be operated normally, and during the other period the HEPA unit will be operated without the internal filter in place (i.e., "placebo filtration"), thus blinding participants to the filters' status. The order of filtration or non-filtration will be random. At the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.

Eligibility criteria: Inclusion Criteria:

* 19 years or older
* Non-smoking household
* Lives in study region (Smithers or Telkwa British Columbia)

Exclusion Criteria:

-

Primary outcomes:
measure: Reactive hyperemia index
timeFrame: After 1 week of air filtration
Secondary outcomes:
measure: C-reactive protein
timeFrame: After 1 week of filtration
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Simon Fraser University
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Ryan Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen RW, Carlsten C, Karlen B, Leckie S, van Eeden S, Vedal S, Wong I, Brauer M. An air filter intervention study of endothelial function among healthy adults in a woodsmoke-impacted community. Am J Respir Crit Care Med. 2011 May 1;183(9):1222-30. doi: 10.1164/rccm.201010-1572OC. Epub 2011 Jan 21.
Clinical trial NCT06488157: Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
Official title: Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old and \< 100 years
* English speaking
* Providing care to an ADRD patient who is age ≥ 65 years old and \< 105 years who is a stage 7a-f on the Functional Assessment Staging Tool (FAST) scale

Exclusion Criteria:

* Non-English speaking
* \<18 years old or \>100 years old

Primary outcomes:
measure: Feasibility, as measured by the percentage of caregivers who enroll in the study
timeFrame: Day 1
measure: Feasibility, as measured by the percentage of participants who complete their telehealth visits
timeFrame: At the end of the intervention or at 12 weeks, whichever is earlier
Secondary outcomes:
measure: Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 weeks
measure: Change in caregiver depression, as measured by Patient Health Questionnaire-8
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 weeks
measure: Change in caregiver anxiety, as measured by General Anxiety Disorder-7
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 weeks
measure: Change in caregiver burden, as measured by the Zarit Burden Interview - short version
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 weeks
measure: Change in caregiver perception of patient's pain, as measured by the Doloplus 2 Scale behavioral assessment
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Veerawat Phongtankuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935857: Balloon Colonoscopy for Incomplete Colonoscopy
Official title: Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diverticulosis
Keywords: Balloon Enteroscopy
Looping
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.

Detailed description: Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort.

Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

Eligibility criteria: Inclusion Criteria:

* prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete

Exclusion Criteria:

* incomplete colonoscopy due only to poor bowel preparation or inadequate sedation

Primary outcomes:
measure: Complete Colonoscopy to the Cecum
timeFrame: Day of Procedure
Secondary outcomes:
measure: Time (Minutes) to Cecum
timeFrame: Day of Procedure
measure: Procedural Complications
timeFrame: 7 days post procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rajesh N Keswani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358057: Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?
Official title: Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Procedural Sedation
Keywords: Deep sedation
Dexmedetomidine
Emergency Service, Hospital
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-02-06
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: TREATMENT

Brief summary: The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.

Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.

Patients will also receive a dose of alfentanil, 1 minute before the technical act.


Eligibility criteria: Inclusion Criteria:

Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:

* The insertion of a chest drain
* Abscess incision and drainage
* Closed reduction of a dislocated joint

Exclusion Criteria:

* Patients refusing to participate in the study (refusal to sign the consent form)
* Patients refusing sedation
* Patients unable to participate in the study (consent is impossible to obtain)
* Pregnant women
* The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
* Patients with poor respiratory status determined by:

Respiratory rate \> 30 / min Oxygen saturation \<90%

* Patients with unfavorable hemodynamic status determined by :

A heart rate \> 120 / min A heart rate \< 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg

* Patients with contraindication to the use of dexmedetomidine :

Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease

Primary outcomes:
measure: Ramsay score scale
timeFrame: 2 hours
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: St Luc
name: Franck Verschuren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092157: Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: High cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 571
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
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 evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.

Detailed description: The duration of treatment is 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Elevated cholesterol level

Exclusion Criteria:

* Liver disease
* Known allergies to study drugs

Primary outcomes:
measure: Fasting triglyceride levels at 12 weeks.
Secondary outcomes:
measure: Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol. 2005 Feb 15;95(4):462-8. doi: 10.1016/j.amjcard.2004.10.012.
citation: Grundy SM, Vega GL, Tomassini JE, Tershakovec AM. Correlation of non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). Am J Cardiol. 2009 Aug 15;104(4):548-53. doi: 10.1016/j.amjcard.2009.04.018.