louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00249938: Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
Official title: Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Dyslipidemia
Keywords: Antilipemic agents
hyperlipidemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2005-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
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 see if combination therapy with a "statin" medication and two additional agents that work differently than "statin" medications can further lower the so-called "bad cholesterol." One therapy is a prescription drug approved by the Food and Drug Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart Wise orange juice. This study juice is available in supermarkets and contains plant sterols that have been shown to lower cholesterol.

Detailed description: Coronary heart disease (CHD) is the primary cause of morbidity and mortality in the United States. Lowering LDL cholesterol in both patients with and without CHD reduces coronary events and death. Statin medications are the primary mechanism of lowering LDL cholesterol, but some patients do not reach their goal LDL with maximum tolerated statin doses and must utilize combination therapy to further lower cholesterol. Additionally, some patients prefer to utilize "natural" mechanisms to lower cholesterol. This prospective, double-blinded, randomized study will compare plant sterol (natural cholesterol treatment) with placebo in patients treated with combination statin and colesevelam therapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of high cholesterol being treated with a statin
* LDL cholesterol greater than 100
* Ability to swallow large tablets

Exclusion Criteria:

* Diabetes
* Use of other medications to treat high cholesterol
* History of liver disease

Primary outcomes:
measure: LDL cholesterol
Secondary outcomes:
measure: Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sunny Linnebur, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855438: Increasing Communication About Live Donor Kidney Transplant
Official title: Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Candidates
Keywords: Live donor kidney transplantation
Living donation
Patient education
Kidney transplant candidates
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-05-16
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* Wait listed for kidney transplantation in active status (i.e., status 1 or 2)
* Adult (at least 18 years of age)
* English speaking
* Capable of making medical decisions (i.e., not cognitively impaired)
* Non-institutionalized

Exclusion Criteria:

* Not listed for kidney transplantation or wait listed, but not in active status
* Under 18 years of age
* Non-English speaking
* Cognitively impaired
* Institutionalized

Primary outcomes:
measure: Change in the number of individuals screened as potential living donors
timeFrame: Upon enrollment (baseline); 1 month post; 3 months post
Secondary outcomes:
measure: Change in intentions to discuss live donor kidney transplantation
timeFrame: Upon enrollment (baseline); 1 month post; 3 months post
measure: Change in engagement in discussion about live donor kidney transplantation
timeFrame: Upon enrollment (baseline); 1 month post; 3 months post
measure: Change in the number of living donor kidney transplants performed
timeFrame: At study commencement; after all program sessions (interventions) are completed; at study conclusion
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Heather M Traino, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543138: The Development and Experimental Application of a New Thoracostomy Trocar
Official title: The Development and Experimental Application of a New Thoracostomy Trocar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness.

Detailed description: The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure that the chest tube proceeds in only one direction. The mold also has a mark to indicate insertion depth. Sixteen participants without experience with thoracostomies observed one closed thoracostomy procedure using the new trocar and then performed three thoracostomies on a cadaver. For each of these thoracostomies, investigators measured the time required for chest tube insertion, the position of the tip of the chest tube within the thoracic cavity, the difficulty associated with the procedure, and the volunteer's confidence after the procedure.

Eligibility criteria: Inclusion Criteria:

* Senior medical students without prior experience with closed thoracostomies

Exclusion Criteria:

* Wrist disease, Pregnancy, Do not want to participate

Primary outcomes:
measure: Time to closed thoracostomy
timeFrame: 5 minutes
Secondary outcomes:
measure: The accuracy of the position of the tip of the chest tube
timeFrame: 5 minutes
Other outcomes:
measure: Scale of procedural difficulty
timeFrame: within 2 minutes
measure: Scale of procedural confidence
timeFrame: within 2 minutes
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University, College of Medicine
Study officials:
affiliation: Hanyang University
name: YOON-JE LEE, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Choi HJ, Lim TH, Lee SH, Hwang SJ. The development and experimental application of a new thoracostomy trocar. Am J Emerg Med. 2016 May;34(5):917-20. doi: 10.1016/j.ajem.2016.02.016. Epub 2016 Feb 12. No abstract available.
Clinical trial NCT03104023: Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG
Official title: Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vomiting, Postoperative
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material

Postoperative nausea and vomits during the first 24 hours will be investigated.

Detailed description: Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).

Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.

Eligibility criteria: Inclusion Criteria:

* BMI \>40
* BMI\>35 with obesity-related comorbidities

Exclusion Criteria:

* Patients undergoing other bariatric techniques than sleeve gastrectomy
* Laparotomic approach

Primary outcomes:
measure: Postoperative nausea and vomits
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital general Universitario de Elche
state: Alicante
Study officials:
affiliation: Hospital general Elche
name: Jaime Ruiz-Tovar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00363623: Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: CIBA VISION
First posted: 2006-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.


Eligibility criteria: Inclusion Criteria:

* Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
* Is an experienced soft contact lens wearer for at least 1 month.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye surgery or injury within 12 weeks prior to enrolment.
* Has any systemic disease or ocular abnormality that might interfere with contact lens wear
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* PMMA lens wear previous 6 months.
* EW or CW in previous 1 month.
* Hydrogen peroxide users
* Latex sensitivity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Clinical Vision Research Australia
state: Victoria
Study officials:
affiliation: Clinical Vision Research Australia, University of Melbourne
name: Carol Lakkis, BScOptom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208323: Advancement of Modified Bubble CPAP
Official title: Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoxia
Respiratory Distress
Keywords: Hypoxia
Respiratory Distress
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 87
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.

Detailed description: This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)

Eligibility criteria: Inclusion Criteria:

* Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation \<92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score \>3

Exclusion Criteria:

* Pneumothorax
* Congenital lung disease
* Cyanotic heart disease
* Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
* Nasal tissue injury
* Active nosebleed
* Recent abdominal surgery or significant abdominal distension
* Agonal respirations
* GCS \<3
* Imminent death within the next 1-2hou

Primary outcomes:
measure: determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
timeFrame: 28 days
Secondary outcomes:
measure: show decreased mortality in patients treated with a modified bCPAP respiratory support device.
timeFrame: 28 days
Other outcomes:
Locations:
city: Gulu
country: Uganda
facility: Gulu Regional Referral Hospital
Study officials:
affiliation: University of Minnesota
name: Ashley Bjorklund, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02704923: Atropine for Preventing Ventilator-Associated Pneumonia
Official title: Atropine for Preventing Ventilator-Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventilator-Associated Pneumonia
Keywords: Atropine
Pneumonia
Ventilator
Adults
Intensive care unit.
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 40
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: A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

Detailed description: A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.

Eligibility criteria: Inclusion Criteria:

* Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours

Exclusion Criteria:

* Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape

Primary outcomes:
measure: Ventilator-Associated Pneumonia
timeFrame: through the end of the study, an average of one year
Secondary outcomes:
measure: Death
timeFrame: through the end of the study, an average of one year
Other outcomes:
measure: Adverse events
timeFrame: through the end of the study, an average of one year
Locations:
Study officials:
References:
Clinical trial NCT03893123: Prostate Cancer Risk in Firefighters
Official title: Prostate Cancer Risk in Firefighters: Its Association to Qualitative and Quantitative Indicators of Exposure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Extrastiftelsen
name: National Institute of Occupational Health
name: Norwegian Confederation of Trade Unions
name: Fagforbundet
name: Gjensidige Foundation
name: Norwegian Cancer Society
name: Norwegian Firefighters Fight Cancer
name: Norwegian Labour Inspection Authority
First posted: 2019-03-28
Enrollment: 4500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Norwegian males

Brief summary: Firefighters have been shown to be at increased risk for various types of cancer, including prostate cancer. This study will try to explore possible reasons for this increase in risk. A study group at the Cancer Registry of Norway is creating a cohort of Norwegian firemen employed from 1960 onwards. A job exposure matrix (JEM) is also being constructed, examining different types of exposure to potentially cancer-inducing agents and activities, and how these have changed historically. Examples include exposure to fire-smoke, shiftwork, diesel exhaust and regular health check-ups. By linking the cohort with data from the Cancer Registry of Norway and the JEM the investigators can examine which exposure assessments, if any, are related to an increased risk of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Work as firefighter as recorded by the participating fire stations

Exclusion Criteria:

* Any other occupation, including chimney sweepers

Primary outcomes:
measure: Incidence of prostate cancer
timeFrame: From January 1st 1960 until December 31st 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
References:
Clinical trial NCT03206723: Bandage Contact Lenses for Corneal Abrasions
Official title: Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Corneal Abrasion
Eye Trauma
Keywords: corneal abrasion
contact lens
eye trauma
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.


Eligibility criteria: Inclusion Criteria:

* Subjects between ages 18-65 years who present to the emergency department.
* Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye.

Exclusion Criteria:

* Pregnant women
* Breast-feeding women
* Corneal abrasion associated with the wearing contact lenses
* Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision
* Wound healing deficits such as collagen vascular disease or concomitant steroid use
* Use of other ocular medications, dry eyes, blepharitis
* Systemic infections
* Known allergies to medicines used in the study

Primary outcomes:
measure: Pain scale
timeFrame: 24 hours post treatment
Secondary outcomes:
measure: Corneal defect size
timeFrame: 24 hours post treatment
measure: Pain medication needed
timeFrame: 24 hours post treatment
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT04469023: Late Phase II Study of TS-142 in Patients with Insomnia
Official title: Late Phase II Study of TS-142 in Patients with Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients with Insomnia
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.


Eligibility criteria: Inclusion Criteria:

* Japanese male and female age 20 years or older at the time of informed consent
* Outpatients
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
* Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
* Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: LS mean difference from placebo; Change between baseline and end of the study of sSL
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: LS mean difference from placebo; Change between baseline and end of the study of sTST
timeFrame: Baseline and Week 2
measure: LS mean difference from placebo; Change between baseline and end of the study of sWASO
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References: