louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02085824: Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Official title: Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Blood Loss
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).


Eligibility criteria: Inclusion Criteria:

* primary, end-stage hip osteoarthritis requiring total hip arthroplasty

Exclusion Criteria:

* inflammatory arthropathies
* liver disorders
* neoplastic conditions
* clotting disorders

Primary outcomes:
measure: Total blood loss by the 3rd postoperative day
timeFrame: 3rd day postoperatively
Secondary outcomes:
measure: Drop in the haemoglobin value between 3rd day postop and preoperative
timeFrame: 3rd day postopertively
measure: Wound healing disturbances according to the definition of Centers for Disease Control and Prevention
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
state: Woj. Mazowieckie
Study officials:
affiliation: The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System
name: Marcin K Wasko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139424: Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing
Official title: Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative
Anastomosis, Surgical
Keywords: surgical leak
endoscopic suturing
Anastomotic leakage
esophageal or gastric resection
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2010-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.


Eligibility criteria: Inclusion Criteria:

* leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection

Exclusion Criteria:

* tubular ischemia of the upper GI tract
* inability to provide informed consent

Primary outcomes:
measure: Safety
timeFrame: 2 years
measure: Technical feasibility
timeFrame: 2 years
Secondary outcomes:
measure: Time to healing of the anastomotic leak
timeFrame: 2 years
measure: Long term safety
timeFrame: 6 months after diagnosis of anastomotic leakage
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: UKSH
state: SH
Study officials:
affiliation: UKSH
name: Annette Fritscher-Ravens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231424: Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease
Official title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 713
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of chronic obstructive respiratory tract disease

Brief summary: The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of either sex, including children over 6 years
* Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Primary outcomes:
measure: Overall severity of the clinical picture rated on a 4-point scale
timeFrame: after 3 and 6 weeks
Secondary outcomes:
measure: Changes in dyspnea and/or asthma attacks rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of dyspnea episodes rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of awakenings due to night-time dyspnea rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of morning coughing with expectoration rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of tolerability on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 weeks
measure: Changes in pathological auscultation findings rated on a 3-point scale
timeFrame: after 3 and 6 weeks
measure: Changes in concomitant medication
timeFrame: up to 6 weeks
measure: Assessment of efficacy on a 4-point scale
timeFrame: after 3 and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02478424: Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease
Official title: Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graft vs Host Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-06-23
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: PREVENTION

Brief summary: Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.

The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.


Eligibility criteria: Inclusion Criteria:

1. Acute leukemia in complete remission
2. Myeloablative conditioning
3. Matched or one antigen or allele mismatched sibling or unrelated donor

Exclusion Criteria:

1. History of psychosis
2. Bronchial asthma

Primary outcomes:
measure: Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100
timeFrame: 100 days
measure: grade 3-4 adverse effects attributed to CBD consumption
timeFrame: 180 days
measure: Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months
timeFrame: 12 months
measure: Incidence of late onset acute GVHD
timeFrame: 12 months
Secondary outcomes:
measure: Non relapse mortality
timeFrame: 12 months
measure: Relapse rate
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Adherence to study protocol
timeFrame: Until day 100
measure: Disease free and immunosuppression free survival by 12 months
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02510924: Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq
Official title: Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq in Adults With a Simulated Difficult Airway With a Cervical-spine Collar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Arthrosis
Keywords: Intubation
Airtraq
General anesthesia
Difficult airway
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.

Detailed description: Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway.

Patients will be included if they necessitate an elective general anesthesia and orotracheal intubation.

Exclusion criteria are related to difficult airway, ASA IV and patient refusal.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent

Exclusion Criteria:

* American Society of Anesthesia classification 4, patient refusal, history of difficult airway

Primary outcomes:
measure: Success
timeFrame: 180 seconds
Secondary outcomes:
measure: Number of attempts
timeFrame: 180 seconds
measure: Number of injuries
timeFrame: 180 seconds
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Anesthesiology, University of Lausanne CHUV
state: VD
Study officials:
affiliation: University of Lausanne Hospitals
name: Patrick Schoettker, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoettker P, Corniche J. The AirView Study: Comparison of Intubation Conditions and Ease between the Airtraq-AirView and the King Vision. Biomed Res Int. 2015;2015:284142. doi: 10.1155/2015/284142. Epub 2015 Jun 16.
Clinical trial NCT06052124: Augmented Reality for Subdural Drain Placement
Official title: Merging Augmented Reality and Neuroimaging to Improve Patient Safety and Outcomes for Neurosurgical Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subdural Hematoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Detailed description: Chronic/subacute subdural hematoma (SDH) is one of the most common diseases encountered in neurosurgical practice. However, there is little consensus on first-line treatment. The SEPS was developed to implement a minimally invasive approach to drainage. New imaging technologies, such as augmented reality (AR) interfaces, can provide anatomical models and can help visualize hidden structures. The hope is that this study can give insight on whether AR-guidance can be used to improve SEPS placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.

Eligibility criteria: Inclusion Criteria:

* Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS

Exclusion Criteria

* Unable to have CT scan
* Pregnancy

Primary outcomes:
measure: Mean accuracy (in mm) of SEPS placement
timeFrame: Intra-procedural and up to 24 hours post procedure
Secondary outcomes:
measure: Change in size (mm) of subdural hematoma
timeFrame: Pre-procedure and 24 hours after SEPS placement
measure: Change in symptom score
timeFrame: Assess at 24 hours status post SEPS placement and again at 1 month
measure: Length of hospital stay
timeFrame: Approximately 2 to 5 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University
name: Vivek P Buch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234024: Oral Supplementation of Gangliosides to Treat a Rare Metabolic Disorder
Official title: Oral Supplementation of Gangliosides - A Potential Treatment for GM3 Synthase Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GM3 Synthase Deficiency
Lead sponsor: DDC Clinic - Center for Special Needs Children
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 20
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot project is to see if a supplemental form of dietary gangliosides can serve as a potential treatment for the rare metabolic condition called ganglioside GM3 synthase deficiency.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of GM3 synthase deficiency

Exclusion Criteria:

-

Primary outcomes:
measure: Body length compared to normal pediatric growth curves.
timeFrame: Quarterly measures- change from baseline over 24 months.
measure: Change in scores of standardized developmental assessments (Vineland & Batelle)
timeFrame: Quarterly measures - change from baseline over 24 months
measure: Body Weight compared to normal pediatric growth curves
timeFrame: Quarterly measurements from baseline over 24 months
measure: Head circumference compared to normal pediatric growth curves.
timeFrame: Quarterly measures from baseline over 24 months
Secondary outcomes:
measure: Concentration of ganglioside GM3 in blood plasma
timeFrame: Six times per year over 24 months
Other outcomes:
Locations:
Study officials:
affiliation: DDC Clinic
name: Heng Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07001124: To Compare the EAR of Duochrome Test With +1 Blur Test Based Refraction for Identification of RE in Different Ages
Official title: To Compare the Efficacy, Accuracy and Reliability of Duochrome Test With +1 Blur Test Based Refraction for Identification of Refractive Errors in Different Ages.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains underexplored in current ophthalmic research. While the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not been thoroughly investigated.

Detailed description: This study aims to evaluate the efficacy, accuracy, and reliability of the duochrome test in identifying refractive errors, including myopia, hyperopia, and astigmatism, across various ages. Refractive errors, including myopia, hyperopia, and astigmatism, are leading causes of visual impairment, requiring precise diagnostic tools. The duochrome test utilizes chromatic aberration to refine prescriptions, whereas the +1 blur test assesses spherical correction accuracy.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 60 years old.
* Both genders.
* Those who have refractive error.
* Patients with no history of prior eye surgery.
* No active eye diseases affecting visual acuity, such as cataracts or retinal disorders.
* Ability to cooperate with both the duochrome test and +1 blur test.

Exclusion Criteria:

* Patients with severe visual impairment or neurological conditions affecting vision.
* Patients with nystagmus or conditions that could interfere with reliable testing.
* Age below 18 year and above 60 year excluded
* Those patients who don't show their consent."

Primary outcomes:
measure: Visual Function Index (VF-14) Questionnaire:
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
state: Punjab
Study officials:
References:
Clinical trial NCT00854724: Puerarin Effects on Alcohol Drinking
Official title: Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Abuse
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

Detailed description: Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Eligibility criteria: Inclusion Criteria:

* moderate to heavy alcohol drinkers (20+ drinks per week)

Exclusion Criteria:

* alcohol dependence or treatment-seeking drinkers
* other drug abuse or dependence
* psychiatric disorders

Primary outcomes:
measure: Amount of Alcohol Consumed
timeFrame: During a 90 minute drinking session
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital, Behavioral Psychopharmacology Research Laboratory
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David M. Penetar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lukas SE, Penetar D, Berko J, Vicens L, Palmer C, Mallya G, Macklin EA, Lee DY. An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy drinkers in a naturalistic setting. Alcohol Clin Exp Res. 2005 May;29(5):756-62. doi: 10.1097/01.alc.0000163499.64347.92.
Clinical trial NCT04369924: Personalized Assessment of Client Experiences
Official title: Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder in Adolescence
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: National Institute of Mental Health (NIMH)
First posted: 2020-04-30
Enrollment: 1261
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two clinical approaches to youth mental health care.


Eligibility criteria: Inclusion Criteria:

1. Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics.
2. The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth.
3. If the family consents to complete additional research measures, one parent and/or primary caregiver must be available and willing to participate in all study assessments.
4. Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish.

Exclusion Criteria:

* no other exclusion criteria

Primary outcomes:
measure: Change in The Ohio Scales Problem Severity Scale Youth Report
timeFrame: baseline, 12 weeks
measure: Change in The Ohio Scales Problem Severity Scale Caregiver Report
timeFrame: baseline, 12 weeks
measure: Change in The Ohio Scales Problem Functioning Scale Youth Report
timeFrame: baseline, 12 weeks
measure: Change in The Ohio Scales Problem Functioning Scale Caregiver Report
timeFrame: baseline, 12 weeks
measure: Change in Symptoms & Functioning Severity Scale- Youth Report
timeFrame: baseline, up to 18 months
measure: Change in Symptoms & Functioning Severity Scale- Caregiver Report
timeFrame: baseline, up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Health Connect America
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Susan Douglas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Amanda Jensen-Doss, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: