louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04649788: Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.
Official title: Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker
Implantable Cardioverter-defibrillator
Keywords: pacemaker
implantable cardioverter-defibrillator
axillary vein
cephalic vein
ultrasound
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 200
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: Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique.

The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED.

Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)

Exclusion Criteria:

* History of previously implanted endocardial lead
* Indication for cardiac resynchronization therapy
* Impossibility of venous access
* Unable/unwilling to provide informed consent
* Pregnant or breastfeeding woman
* Participating in another clinical study which can interfere with this study

Primary outcomes:
measure: Success of venous access
timeFrame: Intervention time (day 0)
Secondary outcomes:
measure: Time to venous access
timeFrame: Intervention time (day 0)
measure: Procedure duration
timeFrame: Intervention time (day 0)
measure: Fluoroscopy time
timeFrame: Intervention time (day 0)
measure: X-Ray exposure
timeFrame: Intervention time (day 0)
measure: Complication
timeFrame: Intervention time (day 0)
measure: Cardiac implantable electronic device (CIED) related infection
timeFrame: Month 3
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital de la Croix Rousse
Study officials:
References:
Clinical trial NCT01935388: Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
Official title: Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventilator Associated Pneumonia
Keywords: Mechanical ventilation
chronic obstructive pulmonary disease
asthma
common canister
MDI
ventilator associated pneumonia
Lead sponsor: Barnes-Jewish Hospital
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings.

Common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. However, the average length of stay for most inpatients is only several days. Therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted.

The common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). This study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.


Eligibility criteria: Inclusion Criteria:

* mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit

Exclusion Criteria:

* lung transplant
* neutropenic
* contact isolation

Primary outcomes:
measure: Ventilator-associated pneumonia (VAP)
timeFrame: 48 hours after intubation
Secondary outcomes:
measure: Inhaler drug cost
timeFrame: During period of mechanical ventilation, which varies depending on patient's severity of illness and reason for intubation; on average may range from 3-5 days.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marin Kollef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gowan M, Bushwitz J, Watts P, Silver PC, Jackson M, Hampton N, Kollef MH. Use of a Shared Canister Protocol for the Delivery of Metered-Dose Inhalers in Mechanically Ventilated Subjects. Respir Care. 2016 Oct;61(10):1285-92. doi: 10.4187/respcare.04550. Epub 2016 May 3.
Clinical trial NCT03587688: Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland
Official title: Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Mitral Valve Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 701
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009

Brief summary: A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Retrospective data (since 2009) as well as prospective data are included in this ongoing registry to analyse the development of mitral valve surgery at the Department of Cardiac Surgery University Hospital of Basel/ Switzerland.


Eligibility criteria: Inclusion Criteria:

- patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009

Exclusion Criteria:

- patients refusing consent for data use

Primary outcomes:
measure: correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient
timeFrame: 4 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: University Hospital Basel, CH-4031 Basel
name: Martin Grapow, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051688: Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2003-01-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.


Eligibility criteria: * Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy.
* Patients must have at least one measurable tumor.
* Patients may not have received prior treatment with oxaliplatin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: ACRC/Arizona Clinical Research Center
state: Arizona
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Centers of the Desert
state: California
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center, Lombardi Cancer Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
Study officials:
References:
Clinical trial NCT01836588: New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CIN
Cervical Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsche Klinik fuer Diagnostik
First posted: 2013-04-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.


Eligibility criteria: Inclusion Criteria:

* Women between 18 and 80
* Karnofsky-Index of 80 and higher
* Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)

Exclusion Criteria:

* Former malign disease oft he pelvic organs
* Pregnancy
* Serious internistic diseases
* Drug addiction

Primary outcomes:
measure: pathological comparative results and all cause mobidity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charité University Berlin, Germany
name: Achim Schneider, Prof. Dr., MPH
role: STUDY_CHAIR
References:
Clinical trial NCT04908488: Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Official title: Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Ametropia
Astigmatism
Keywords: Contact Lenses
Disposable
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will receive treatment based upon the randomized treatment sequence assignment.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Detailed description: Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Eligibility criteria: Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
* Any spherical monovision and multifocal lens wearers.
* Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance VA (logMAR) With Study Lenses
timeFrame: Day 8 (-0/+3 days), each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alcon Investigator 8135
state: California
city: Oakland
country: United States
facility: Alcon Investigator 8062
state: California
city: Orlando
country: United States
facility: Alcon Investigator 6355
state: Florida
city: Franklin Park
country: United States
facility: Alcon Investigator 6614
state: Illinois
city: Shawnee Mission
country: United States
facility: Alcon Investigator 6645
state: Kansas
city: Wyomissing
country: United States
facility: Alcon Investigator 3382
state: Pennsylvania
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigator 2786
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06558188: Combined Anabolic Therapy
Official title: Combined Anabolic Therapy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-08-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.


Eligibility criteria: Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* known contraindications to romosozumab or teriparatide

Primary outcomes:
measure: Lumbar spine areal bone mineral density
timeFrame: Month 0 to 12
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Benjamin Leder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05337488: Contributing Factors of Solitary Drinking Among Adolescents and Young Adults
Official title: Exploring the Contributing Factors of Solitary Drinking Among Hong Kong Chinese Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Drinking
Alcohol Use Disorder
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults with solitary drinking behaviour

Brief summary: A convenience sample of 40 solitary drinkers aged between 10 and 24 will be invited to complete a structured questionnaire and a individual semi-structured interviews.


Eligibility criteria: Inclusion Criteria:

* 10-24 years old,
* able to speak Cantonese
* self-report as exhibiting solitary drinking behaviour

Exclusion Criteria:

* None

Primary outcomes:
measure: solitary drinking episode
timeFrame: past 30 days
measure: percent of drinking time spent on solitary drinking
timeFrame: past 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02775188: interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
Official title: interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Subjects will undergo weekly physical therapy or weekly physical therapy paired with InterACTION.


Eligibility criteria: Inclusion Criteria:

1. Between 15 to 30 years of age;
2. Have undergone ACL Reconstruction;
3. Being referred for post-operative outpatient physical therapy;
4. Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.

Exclusion Criteria:

1. Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
2. Patients with BMI \>40 at the time of surgery;
3. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of physical therapy exercises;

Primary outcomes:
measure: Value evaluated by the ratio of patient outcomes to costs of rehabilitation
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01646788: Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae
Lead sponsor: N.M.B. Medical Applications Ltd
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years old or older.
2. Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
3. Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
4. Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits).

Exclusion Criteria:

1. Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
2. Previous participation in another study with any investigational drug or device within the past 30 days.
3. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
4. Known hypersensitivity to paclitaxel or structurally-related compounds.
5. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
6. Stenosis with corresponding thrombosis treated within 7 days before enrollment.
7. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
8. Infected grafts/fistulae.

Primary outcomes:
measure: Restenosis rate
timeFrame: 6 months
Secondary outcomes:
measure: restenosis rate
timeFrame: 1, 3 and 12 months
measure: Easy insertion and removal
timeFrame: intraprocedural
measure: Major adverse events rate
timeFrame: intraprocedural 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: The Rabin Medical Center, Hasharon Hospital
Study officials:
References:
Clinical trial NCT02442388: Postoperative Pain of Root Canal Therapy With Three Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
root canal therapy
endodontics
file
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.

Detailed description: ProTaper Universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. A unique design element is varying tapers along the instruments' long axes. The three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. Wave-One is reciprocation-based systems that instrumented root canals with only single file. Some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a NiTi instrument and increases its fatigue resistance in comparison with continuous rotation motion.

Eligibility criteria: Inclusion Criteria:

* Healthy patient

Exclusion Criteria:

* Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling

Primary outcomes:
measure: Pain as assessed by Heft-Parker VAS
timeFrame: After each technique, up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: