louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01026103: Tri Staple Technology Stapler Used in Gastric Bypass
Official title: A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Hypertension
Hyperlipidemia
Coronary Artery Disease
Gastroesophageal Reflux Disease
Osteoarthritis
Diabetes
Keywords: gastric bypass
Gastric bypass surgery
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.


Eligibility criteria: Inclusion Criteria:

* The patient must be 18-65 years of age.
* The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
* The patient is pregnant.
* The patient has an active or history of, infection at the operative site.
* The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Patient has an abdominal ventral hernia requiring mesh repair
* The patient has a history of clinically significant liver disease
* The patient has a history of drug or alcohol abuse within 2 years of enrollment
* The patient has a history of venous thrombosis or pulmonary embolism
* The patient has a history of coagulopathy

Primary outcomes:
measure: Proportion of Patients With an Uneventful Creation of a Functional Staple Line
timeFrame: Day 0
Secondary outcomes:
measure: Incidence of Intra-operative Bleeding Requiring Intervention
timeFrame: Day 0 and 1 month
measure: Length of Hospital Stay
timeFrame: Date of discharge which averages 3 days
measure: Incidence of Serosal Tearing
timeFrame: 30 days post op
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian Bariatric Center/Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Samer G Mattar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380003: Efficacy Study of EVT 201 to Treat Insomnia
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Evotec International GmbH
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).


Eligibility criteria: Inclusion Criteria:

* must have a diagnosis of primary insomnia
* over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
* must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
* must be willing and able to complete a sleep diary and questionnaires

Exclusion Criteria:

* must not have a clinically significant or unstable medical condition that may interfere with sleep
* must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
* must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
* must not intentionally nap 3 (or more) times per week
* must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)

Primary outcomes:
measure: Total Sleep Time
measure: Wake after sleep onset
Secondary outcomes:
measure: Latency to persistent sleep
measure: Number of awakenings
measure: Total wake time
measure: Minutes of stages 1-4 and REM sleep
measure: REM latency
measure: Patient reported sleep variables
measure: Residual sedation measures
measure: Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: St Petersburg Sleep Disorders Center
state: Florida
city: Atlanta
country: United States
facility: The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
state: Georgia
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Chesterfield (St Louis)
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center
state: Ohio
Study officials:
affiliation: St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
name: James K Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395603: Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
Official title: Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Diabetes Mellitus
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 550
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: To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
* Existing coronary heart disease and cholesterol \> 4.0 mmol/l

Exclusion Criteria:

* Uncontrolled diabetes
* Elevated liver function tests
* Elevated creatine kinase (ck)
* Triglycerides (tg) \> 4.5 mmol/l
* Drug or alcohol dependency within 6 months prior to visit 1
* Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
* Woman of childbearing potential not using an acceptable method of birth control
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Percentage reduction in ldl-c at end-point after 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00300703: OPALS Cardiac Arrest Database (OCAD)
Official title: Ontario Prehospital Advanced Life Support (OPALS) Study Cardiac Arrest Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Canadian Institute for Health Information
First posted: 2006-03-09
Enrollment: 1538
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Ages 16 years and above

Exclusion Criteria:

under 16 yrs

Brief summary: To provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government.

Detailed description: To provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government

Eligibility criteria: Inclusion Criteria:

* Ages 16 years and above

Exclusion Criteria:

under 16 yrs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Cambridge Base Hosptial
state: Ontario
city: Kingston
country: Canada
facility: Kingston Base Hosptial
state: Ontario
city: London
country: Canada
facility: London Base Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Halton Base Hosptial
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Falls Base Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Base Hospital
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Base Hospital
state: Ontario
city: Sarnia
country: Canada
facility: Lambton Base Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Base Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Base Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Base Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Ian Stiell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06750003: 4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison
Official title: 4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Diseases
Keywords: Benign ovarian disease
laparoscopy
annessiectomy
ovariectomy
resident
tridimensional
high definition surgery
3D
4K
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy

Detailed description: All patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic Doppler ultrasound and/or magnetic resonance imaging and/or CT scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. The primary objective of the study is to compare surgical times between the 3D and 4K vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. Secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system

Eligibility criteria: Inclusion Criteria:

* Patients with benign ovarian pathology requiring bilateral oophorectomy
* ASA score \<3
* Patients who have signed the appropriate informed consent
* Patients who are not pregnant or diagnosed with pelvic inflammatory disease
* No history of prior major abdominal surgery

Exclusion Criteria:

* Suspected neoplastic pathology
* Patients not eligible for surgery

Primary outcomes:
measure: operative time
timeFrame: from enrollment to the end of follow up at 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01007903: Mind-Body Exercise for COPD: A Pilot Study
Official title: Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-11-05
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized controlled trial of feasibility and preliminary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease


Eligibility criteria: Inclusion Criteria:

* physician diagnosis of COPD
* FEV1\<65% of predicted and FEV1/FVC\<0.70
* ≥45 years old

Exclusion Criteria:

* COPD exacerbation requiring ER visit or hospitalization within past month
* planned major pulmonary intervention in coming 3 months
* severe peripheral vascular disease/claudication or other physical condition precluding walk test
* inability to perform bicycle ergometry
* severe cognitive dysfunction (MMSE ≤ 24)
* inability to speak English
* current participation in a pulmonary rehabilitation or regular practice of tai chi

Primary outcomes:
measure: Study feasibility
Secondary outcomes:
measure: Quality of life
measure: Exercise capacity
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Gloria Yeh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeh GY, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS. Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study. Respir Care. 2010 Nov;55(11):1475-82.
Clinical trial NCT06311903: Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock
Official title: Is Low Dose Norepinephrine Effective in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Norepinephrine
Hemorrhagic Shock
Hypotensive Resuscitation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 200
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: The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock.

Detailed description: Hemorrhagic shock is one of the leading causes of death following trauma. New fluid resuscitation concepts, including hypotensive, hypothermic, and delayed resuscitation for uncontrolled hemorrhagic shock, have been put forward and obtained a good effect both in clinical and laboratory parameters. The 2019 European guideline on the management of major bleeding and coagulopathy following trauma recommends the use of norepinephrine (NE) for maintaining target arterial blood pressure in patients with life-threatening hypotension. NE has potent α-adrenergic receptor activation activity, which can stimulate α-1 adrenergic receptors on peripheral vascular smooth muscles. High-dose NE may result in excessive arteriolar vasoconstriction which subsequently leads to the disorder of microcirculation and tissue hypoxia.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Both sexes.
* Patients with hemorrhagic shock

Exclusion Criteria:

* Patients with cardiac arrest at admission.
* Severe brain.
* Spinal injury (because of different target blood pressures).
* Death due to hemostatic failure within 6 h of admission.
* Pregnancy.

Primary outcomes:
measure: 24 hours mortality
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 days after intervention
measure: Incidence of acute kidney injury
timeFrame: 24 hours after intervention
measure: Length of hospital stay
timeFrame: 28 days after intervention
measure: Length of intensive care unit stay
timeFrame: 28 days after intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT01173003: Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
Official title: An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Keywords: Medical abortion
mifepristone
misoprostol
Tunisia
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Centre de Formation et de la Recherche, Tunisia
First posted: 2010-07-30
Enrollment: 688
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

The goal of this study is to provide answers to the following four questions:

1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Are women satisfied with counseling and services received in new centers offering medical abortion?


Eligibility criteria: Inclusion Criteria:

* Women presenting for medical abortion who consent to participate
* Possibility of final gestational age of less than or equal to 63 days
* General good health
* Willing to provide contact information for purposes of follow-up

Exclusion Criteria:

* Conditions which contraindicate the use of mifepristone or misoprostol
* Women presenting for medical abortion who do not consent to participate

Primary outcomes:
measure: Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
timeFrame: 2 weeks after mifepristone administration
Secondary outcomes:
measure: Side effects
timeFrame: 48 hours
measure: Acceptability for women
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Centres (14) de Planification Familiale de L'ONFP
state: Various
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: STUDY_CHAIR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: STUDY_DIRECTOR
affiliation: Reproductive Health Consultant
name: Selma Hajri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Office Nationale de la Famille et de la Population
name: Mongia Ben Attia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ONFP
name: N Gueddana, MD
role: STUDY_CHAIR
affiliation: ONFP
name: Fatma Temimi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ONFP
name: E Hassairi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361203: Exercise and Virtual Reality Exposure Therapy for Acrophobia
Official title: Exercise and Virtual Reality Exposure Therapy for Acrophobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Heights
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 25
* Speaks English fluently
* Score of 80 or higher on the Acrophobia Questionnaire
* SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear
* Passes the Physical Activity Readiness Questionnaire-Plus

Exclusion Criteria:

* Hearing or visually impaired
* Currently receiving exposure-based treatment for acrophobia
* Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating \< 50

Primary outcomes:
measure: Fear scores
timeFrame: 7 (+/- 3) days after exposure therapy
measure: Perceived threat likelihood scores
timeFrame: 7 (+/- 3) days after exposure therapy
Secondary outcomes:
measure: Skin conductance fluctuations
timeFrame: 7 (+/- 3) days after exposure therapy
measure: Heart rate fluctuations
timeFrame: 7 (+/- 3) days after exposure therapy
measure: Acrophobia Severity
timeFrame: 14 (+/- 3) days after exposure therapy
measure: Attitudes Toward Heights
timeFrame: 14 (+/- 3) days after exposure therapy
measure: Clinical Global Improvement
timeFrame: 14 (+/- 3) days after exposure therapy
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Jasper Smits, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128203: Effects of Intranasal Oxytocin on Striatal Functional Connectivity
Official title: Effects of Intranasal Oxytocin on Striatal Functional Connectivity in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oxytocin
Resting-state
Functional connectivity
BOLD
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.

Detailed description: In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity.

Subject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain. Trait anxiety and mood questionnaires will be administered as control variables.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* with MRI Contraindications

Primary outcomes:
measure: Striatal functional connectivity alterations after drug administration
timeFrame: 45 minutes after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: School of Life Science and Technology, University of Electronic Science and Technology of China
name: Benjamin Becker, Dr.
role: PRINCIPAL_INVESTIGATOR
References: