louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04149340: Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
Official title: Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Cataract
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Check the sedation conditions during topic cataract surgery


Eligibility criteria: Inclusion Criteria:

* Topic cataract surgery

Exclusion Criteria:

* NA

Primary outcomes:
measure: Patient's satisfaction: four Lickert's scales
timeFrame: During cataract surgery
Secondary outcomes:
measure: Surgeon's satisfaction: four Lickert's scales
timeFrame: During cataract surgery
measure: hemodynamic parameters
timeFrame: Durinf cataract surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liege, University Hospital
Study officials:
References:
Clinical trial NCT04015440: Hostile Bias Modification Training Online Study II
Official title: Hostile Bias Modification Training Online Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Anger
Emotion Regulation
Self-Control
Stress
Keywords: attention bias
hostile attribution bias
hostile bias modification
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
Collaborators: name: Army Research Laboratory
First posted: 2019-07-11
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an online study. Volunteer assignment to each of the two experimental conditions is semi-randomized (i.e. random except that computer ensure equal sample sizes across experimental conditions). The randomized assigning of participants is done by the study web-page/program at volunteerscience.com. The computer program randomly assigned volunteers to one of the two conditions when they begin the study.
Primary purpose: OTHER

Brief summary: The purpose of this study is to see how people respond on a word completion task relates to how they behave and respond to situations in the real world. This is a two part research study. At time-point one, participants will fill out some brief personality surveys. They will also read several short scenarios and imagine how they would react and/or interpret these situations in real life. They will also complete a vocabulary task where they will sort word fragments based on type as quickly as they are able. Participants will be asked to return in 24-96 hours for part two where they will repeat a similar scenario reading activity as during time one and fill out a brief questionnaire about your recent behaviors.


Eligibility criteria: Inclusion Criteria:

1. Adult aged 18 and older
2. Located in the United States or other primarily English speaking country.
3. Active Amazon Account.

Exclusion Criteria:

* Less than 18 years old.
* Not located in the United States or other primarily English speaking country.

Primary outcomes:
measure: Hostile Attribution Bias
timeFrame: 24-96 hours post HBMT
measure: Driving Aggression
timeFrame: 24-96 hours post HBMT
measure: Aggression On Social Media
timeFrame: 24-96 hours post treatment
Secondary outcomes:
measure: Anger
timeFrame: 24-96 hours post HBMT
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Sleep Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT01364740: PMP-300E (Smart Watch): Portable Monitoring Device Study
Official title: PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Detailed description: The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.

Eligibility criteria: Inclusion Criteria:Inclusion Criteria:

* Age 18 and over.
* Require a sleep diagnostic study by physician's order.
* Able and willing to provide written informed consent.
* Able to speak and read English.

Exclusion Criteria:Exclusion Criteria:

* Participation in another interventional research study within the last 30 days.
* Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
* Consumption of ethanol more than 4 nights per week. (CAGE criteria)
* Use of recreational drug within the past 12 months.
* Women who are pregnant or currently lactating.

Primary outcomes:
measure: AHI
timeFrame: One night
Secondary outcomes:
measure: Apnea Index
timeFrame: One night
measure: Hypopnea Index
timeFrame: One night
measure: Oxygen Saturation
timeFrame: One night
Other outcomes:
measure: Attitude Toward Device Use Questionnaire Scores
timeFrame: one night
Locations:
city: Redwood City
country: United States
facility: Center for Human Sleep Research
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Clete A. Kushida M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00040040: Assessment of Potential Interactions Between Methamphetamine and Bupropion - 1
Official title: Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between IV Methamphetamine and Oral Bupropion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amphetamine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of California, Los Angeles
First posted: 2002-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess potential interactions between intravenous (IV) methamphetamine and oral bupropion.

Detailed description: This is a human laboratory clinical pharmacology study to assess potential interactions between IV methamphetamine challenge and treatment with oral sustained-release bupropion.

Eligibility criteria: Inclusion Criteria:

Please contact site director for more details.

Exclusion Criteria:

Please contact site director for more details.

Primary outcomes:
measure: Psychological effects
measure: BP, HR
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Thomas Newton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730140: The Association Between the Intraoperative Blood Pressure Changes and Whole Exome Genome
Official title: Association Between Whole Exon Sequencing and Arterial Stiffness in Patients With Intraoperative Hypotension)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic Effect
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients recieving general anesthesia

Brief summary: The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. In this hypothesis, we aim to elucidate the association between the whole exome genome and intraoperaive blood pressure changes.

Detailed description: We aim to elucidate the association between the whole exome genome and intraoperative blood pressure changes.

We will enroll patients older than 20 years old and undergo elective general anesthesia.

Before anesthesia, we will obtain blood sample for whole exome genome test and give arterial line for intraoperative monitor.

After completing surgery, we will follow the patients' all postoperative major organ function.

We hope this study to be able to give us the more information about the specific genetic effect on the arterial stiffness and intraoperative blood pressure changes.

Eligibility criteria: Inclusion Criteria:

* elective general surgery

Exclusion Criteria:

* coagulopathy

Primary outcomes:
measure: The association between the arterial stiffness and whole exome genome
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00649740: Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Official title: Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 144 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Dorian Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477840: Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Official title: Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bleeding Intraoperative
Keywords: Misoprostol
Oxytocin
Cesarean Delivery
Blood Loss
Lead sponsor: Kermanshah University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Kermanshah University of Medical Sciences
First posted: 2011-11-23
Enrollment: 180
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

Detailed description: A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

Eligibility criteria: Inclusion Criteria:

* Indication of Cesarean Deliveries
* Elective or Emergency with Incision in Lower Segment in Women with
* Gestational Age more than 37 Weeks.

Exclusion Criteria:

* Anemia
* Multiple Pregnancy
* Polyhydraminus
* Prolonged Labor
* Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
* Hypertension
* Cardiovascular Disease
* Coagulopathy Disease

Primary outcomes:
measure: Intraoperative bleeding
timeFrame: At the time of surgery
Secondary outcomes:
measure: Fever
timeFrame: During 48 hours after surgery measured every 3 hours
measure: Changing of pulse rate from base
timeFrame: Before surgery & intraoperative & 6 hours after surgery
measure: Changing of blood pressure
timeFrame: Before surgery & intraoperative & 6 hours after surgery
measure: Diarrhea
timeFrame: Before & 6 hours after surgery
measure: Vomiting
timeFrame: Before & 6 hours after surgery
Other outcomes:
Locations:
city: Kermanshah
country: Iran, Islamic Republic of
facility: KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
Study officials:
affiliation: Kermanshah University of Medical Sciences
name: Anisodowleh Nankali, MD
role: STUDY_CHAIR
References:
citation: Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744.
Clinical trial NCT03279640: Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients
Official title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Motor Disorder
Keywords: Motor Network
Resting-state fMRI
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.

Detailed description: Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.

Eligibility criteria: Inclusion Criteria:

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain

Primary outcomes:
measure: Neuroimaging Assessment
timeFrame: Change from baseline resting-state brain network at 8 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Park E, Lee A, Chang WH, Kim DS, Shin YI, Kim YH. Modulating Brain Connectivity by Simultaneous Dual-Mode Stimulation over Bilateral Primary Motor Cortices in Subacute Stroke Patients. Neural Plast. 2018 Feb 13;2018:1458061. doi: 10.1155/2018/1458061. eCollection 2018.
Clinical trial NCT03689140: Mobile Health Intervention for Family Smoking Cessation in Romania
Official title: Mobile Health Intervention for Family Smoking Cessation in Romania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine: Smoking Cessation App Only
Telemedicine: Smoking Cessation Counseling
Telemedicine: App + Counseling
Usual Care
Keywords: mHealth
Mobile health
Telehealth
Pregnancy
Tobacco
Cessation
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Babes-Bolyai University
name: University of Michigan
name: Wake Forest University Health Sciences
First posted: 2018-09-28
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.


Eligibility criteria: Inclusion Criteria:

* pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
* 18 years or older
* married or in a stable relationship
* owns and uses an Android smartphone with broadband internet connection
* willing to have the partner contacted for participation.

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
timeFrame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
References:
Clinical trial NCT05749640: The Proximal Contact Tightness and Location in Class II Composite Restorations
Official title: Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines
Primary purpose: TREATMENT

Brief summary: This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.


Eligibility criteria: Inclusion Criteria:

* Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
* Presence of the antagonist and the adjacent tooth making contact.
* The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
* Size of the isthmus with no more than 2/3 of the intercuspal distance
* Good oral health and absence of periodontal disease
* Patients who are not suffering from severe systemic diseases or allergies

Exclusion Criteria:

* Medically compromised patients
* Clinical signs of bruxism, traumatic malocclusion
* Pregnant or breast feeding at the time of restoration placement
* Intolerance or allergy toward the applied restorative materials

Primary outcomes:
measure: Change in proximal contact tightness
timeFrame: baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Secondary outcomes:
measure: Change in proximal contact location
timeFrame: baseline and immediately postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Karim Mohamed Wahba Abbass
Study officials:
References: