louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02588976: Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
Official title: Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Techniques and Procedures
Cardiac Surgical Procedure
Keywords: Activated clotting time
Sonoclot
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform kaolin-based activated clotting time as routine monitor of heparin therapy in patients undergoing cardiac operations. In addition, the device allows the assessment of the patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has been developed. As part of the routine management using S1, tests are also performed on S2. Results are entered into the cardiac surgery data base of all cardiac surgery patients and analyzed.

Detailed description: The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to routinely perform kaolin-based activated clotting time (kACT) as monitor of heparin therapy in patients undergoing cardiac operations on cardiopulmonary bypass.

Apart from kACT, the device allows the assessment of the patient's coagulation status by a glass-bead activated test (gbACT+, depicting also clot rate = CR and platelet function = PF). Recently, a new SONOCLOT analyzer (S2) has been developed. Although the S2 shares the technical fundamentals with the S1, the redesign of the device may result in performance changes of kACT and gbACT.

Routine management in cardiac surgery patients is guided using S1 and addition, tests are run on S2. Data are entered into the the cardiac surgery data base and S1 and S2 performance is compared by Bland-Altman analysis and % error calculation in order to establish new reference values.

Eligibility criteria: Inclusion Criteria:

* all consecutive cardiac surgery patients

Exclusion Criteria:

* none

Primary outcomes:
measure: Kaolin-activated Clotting Time
timeFrame: Routine measurements during cardiac surgery
Secondary outcomes:
measure: Glass Bead Activated Clotting Time
timeFrame: Routine measurements during cardiac surgery
Other outcomes:
Locations:
Study officials:
affiliation: Triemli City Hospital
name: Michele Genoni, MD
role: STUDY_CHAIR
References:
citation: Ganter MT, Hofer CK. Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg. 2008 May;106(5):1366-75. doi: 10.1213/ane.0b013e318168b367.
Clinical trial NCT03814876: Family Intervention Following Traumatic Injury
Official title: Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Spinal Cord Injuries
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Victims Fund
name: The Association of Eastern Founders
First posted: 2019-01-24
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.


Eligibility criteria: Inclusion Criteria:

* Acquired brain injury or spinal cord injury
* Talk and read Danish
* Minimum 6 months to 2 years since discharge
* Family members must be actively involved in the patient's rehabilitation

Exclusion Criteria:

* Severe aphasia
* Families, where other family members require a substantial amount of care
* Prior psychiatric or neurological disease

Primary outcomes:
measure: Disease specific quality of life
timeFrame: Change from day 0 to week 8, follow up at six months
measure: Generic quality of life
timeFrame: Change from day 0 to week 8, follow up at six months
measure: Disease specific quality of life
timeFrame: Change from day 0 to week 8, follow up at six months
measure: Caregiver burden
timeFrame: Change from day 0 to week 8, follow up at six months
measure: Self-perceived burden
timeFrame: Change from day 0 to week 8, follow up at six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pernille Langer Soendergaard, MSc
role: STUDY_CHAIR
References:
citation: Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.
citation: Soendergaard PL, Wolffbrandt MM, Biering-Sorensen F, Nordin M, Schow T, Arango-Lasprilla JC, Norup A. A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial. Trials. 2019 Nov 27;20(1):646. doi: 10.1186/s13063-019-3794-5.
Clinical trial NCT01242176: Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
Official title: Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).


Eligibility criteria: Inclusion criteria:

Healthy male and female subjects

Primary outcomes:
measure: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
measure: Maximum Measured Concentration (Cmax)
timeFrame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Secondary outcomes:
measure: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.51.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01983176: Retrospective Clinical Outcome of Parotid Tumor Surgery
Official title: Retrospective Clinical Outcome of Parotid Tumor Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parotid Tumors
Postoperative Complications
Keywords: Parotid tumor
Partial superficial parotidectomy
Facial palsy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 767
Sex: ALL
Minimum age (years): 10
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent parotid surgery by a single operator in National Taiwan University Hospital from January 2004 to December 2012 were assessed for histopathological results and postoperative complications.

Brief summary: The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of parotid tumor
* Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12

Exclusion criteria:

-Inflammation or infection disease of parotid gland

Primary outcomes:
measure: Facial palsy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Jen Lou, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395976: Ayurveda as Prophylaxis for Suspected COVID-19 Patients
Official title: Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid-19
Keywords: Ayurveda
Lead sponsor: British Ayurvedic Medical Council
Sponsor class: OTHER
Collaborators: name: All Party Parliamentary Group - Indian Traditional Sciences
name: University of Warwick
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.


Eligibility criteria: Inclusion Criteria:

* Person who has come into contact with confirmed COVID-19,
* Willing to take study drug as directed

Exclusion Criteria:

* Confirmed current COVID-19
* Inability to take medications orally
* Inability to provide written consent

Primary outcomes:
measure: Clinical confirmation of Covid-19
timeFrame: From date of enrolment to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: British Ayurvedic Medical Council
Study officials:
affiliation: University of Warwick
name: Vishwes Kulkarni
role: PRINCIPAL_INVESTIGATOR
affiliation: All Party Parliamentary Group - Indian Traditional Sciences
name: Amarjeet S Bhamra
role: STUDY_CHAIR
affiliation: British Ayurvedic Medical Council
name: Neha Sharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT01620476: Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers
Official title: A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Japanese
* Body mass index (BMI) between 18 and 27 kg/m\^2 inclusive

Exclusion Criteria:

* Any clinical laboratory values deviated from the reference range at the laboratory
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders.
* History of significant allergy or hypersensitivity
* Known or suspected allergy to trial product or related products.
* History of drug or alcohol abuse
* Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure

Primary outcomes:
measure: Area under the plasma liraglutide curve
Secondary outcomes:
measure: Cmax, maximum plasma liraglutide concentration
measure: tmax, time to reach Cmax
measure: Terminal phase elimination rate-constant
measure: t½, terminal elimination half life
measure: 24-hour profiles of serum insulin
measure: 24-hour profiles of serum glucose
measure: 24-hour profiles of plasma glucagon
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104
Clinical trial NCT00036127: Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: agitated schizophrenic patients
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Study to learn if the alternate formulation is effective in agitated schizophrenic patients


Eligibility criteria: Inclusion Criteria:

* Agitated schizophrenic patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution
state: California
city: Cerritos
country: United States
facility: Local Institution
state: California
city: Chula Vista
country: United States
facility: Local Institution
state: California
city: Rosemead
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Macon
country: United States
facility: Local Institution
state: Georgia
city: Hoffman Estates
country: United States
facility: Local Instituton
state: Illinois
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Nashua
country: United States
facility: Local Institution
state: New Hampshire
city: New York
country: United States
facility: Local Institution
state: New York
city: Beachwood
country: United States
facility: Local Institution
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References:
citation: Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9. doi: 10.4088/jcp.v68n0115.
Clinical trial NCT05558527: The Social Regulation of Threat-related Vigilance and Arousal
Official title: Effects of Trauma and Discrimination on the Social Regulation of Threat-related Vigilance and Arousal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Trauma, Historical
Discrimination, Racial
Emotion Regulation
Social Interaction
Hypervigilance
Anxiety
Keywords: psychological trauma
ethnoracial discrimination
hypervigilance
anticipated threat
social emotion regulation
social touch
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.

Detailed description: Both interpersonal trauma (IPT) and ethno-racial discrimination amplify risk for hyper-arousal symptoms of posttraumatic stress disorder (PTSD), but the mechanism of this effect is unclear. Prior research suggests that social support plays an important role in regulating emotional responses, a process called social emotion regulation. This study will test whether a history of IPT and/or ethno-racial discrimination influence the social regulation of arousal and vigilance. Social regulation will be tested by contrasting responses under conditions with and without social support.

Eligibility criteria: Inclusion Criteria:

* In a stable romantic relationship for 6 months or more
* Normal vision or corrected-to-normal vision
* Fluent in English

Exclusion Criteria:

* If vision is corrected-to-normal, needs to use hard contact lenses, bifocal contact lenses, or glasses
* Experienced a traumatic event within the past 4 weeks

Primary outcomes:
measure: Vigilance Related Eye Movements - Number of Eye Fixations
timeFrame: Collected from minute 15 to minute 45 of study participation, approximately
measure: Vigilance Related Eye Movements - Visual Scanning
timeFrame: Collected from minute 15 to minute 45 of study participation, approximately
measure: Threat-Related Physiological Arousal - Pupil Dilation
timeFrame: Collected from minute 45 to minute 75 of study participation, approximately
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Cynthia L Lancaster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03095027: Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Official title: Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: contact lens, silicone hydrogel, daily disposable, visual acuity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an IRB-approved Informed Consent Form;
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
* Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
* Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* History of refractive surgery or plan to have refractive surgery during the study;
* Ocular or intraocular surgery within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Any previous or current wear of MYDAY;
* Habitually wearing monovision or multifocal lenses during the last 3 months;
* Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: Baseline/Dispense (Day 1), Week 1, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Longwood
country: United States
facility: Alcon Investigative Site
state: Florida
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
Study officials:
affiliation: Alcon, A Novartis Division
name: Sr. Clinical Manager, Trial Management Operations
role: STUDY_DIRECTOR
References: