louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03523897: A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
Official title: A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Osteoarthritis of Knee Nos
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:

1. Patients' self-reported awareness of their artificial joints during activities of daily living;
2. Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
3. Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
4. The accuracy of implant placement and limb alignment


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
3. Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria:

1. Pregnant or contemplating pregnancy prior to surgery;
2. Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
3. Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

Primary outcomes:
measure: Patient Reported Forgotten Joint Score (FJS)
timeFrame: 1 year
Secondary outcomes:
measure: Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year
measure: Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)
timeFrame: 1 year
measure: The Mechanical Alignment of the Post-operative Limb
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Virtua Joint Replacement Institute
state: New Jersey
Study officials:
affiliation: Virtua Joint Replacement Institute
name: Jeremy Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05707897: A Food Effect Study of TS-142 in Healthy Subjects
Official title: A Study to Assess the Food Effect of TS-142 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Effect of Food
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
2. Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
3. Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts

Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Plasma concentration
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 24 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02175797: Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
Official title: Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Pacemaker, leads and MRI exam
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.


Eligibility criteria: Inclusion Criteria:

* Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
* Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
* Patient who fulfils MRI solutions conditions
* Patient who provides signed and dated informed consent

Exclusion Criteria:

* Implanted or planned to be implanted non MR-compatible device or material
* Permanent Atrial Fibrillation (for DR devices)
* Diaphragmatic/phrenic stimulation
* Claustrophobia
* Incessant ventricular tachyarrhythmia
* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical trial that could affect the results of this study
* Patient is minor (less than 18-years old)
* Patient is pregnant - Patient is forfeiture of freedom or under guardianship

Primary outcomes:
measure: Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN
name: Arnaud Mr SAVOURE, cardiologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817297: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Official title: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Respiratory Failure
Keywords: noninvasive ventilation
Lead sponsor: Respironics, California, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 a new noninvasive ventilator to existing ventilators already used for patient care.

Detailed description: The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years and \< 85 years
* Weight \> 20 kg (44 lbs)
* Respiratory failure or respiratory insufficiency
* Ability to cooperate with the investigators

Exclusion Criteria:

* An endotracheal tube or tracheostomy in place
* Hemodynamic instability
* Prolonged apnea
* Inability to maintain the airway
* A recent history of cardiac and or respiratory arrest
* Acute hemorrhage
* Multiple organ system failure
* Undrained pneumothorax
* High risk for aspiration
* Metastatic or terminal cancer
* Do-not-resuscitate orders
* Inability to clear respiratory secretions
* Inability to fit a mask
* Facial surgery, trauma, or deformity
* Upper gastrointestinal or airway surgery
* Pregnancy
* Refractory delirium
* Inability or unwillingness to provide Informed Consent
* PaO2 \< 50 mmHg

Primary outcomes:
measure: Breathing comfort
timeFrame: 0, 15, and 30 minutes
Secondary outcomes:
measure: Physiological variables
timeFrame: 0, 15, and 30 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: GF-221 Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba, Winnipeg, Manitoba, Canada
name: Steven Mink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05368597: CompArison of PCI in NaTive Arteries Versus ByPAss Grafts In PatieNts With Prior CABG (CAPTAIN)
Official title: Comparison of Percutaneous Coronary Intervention in Native Arteries Versus Bypass Grafts in Patients With Prior Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass grafting
percutaneous coronary intervention
coronary artery disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 1491
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary artery disease patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting

Brief summary: Coronary atherosclerotic heart disease (CAD) has been considered the leading cause of death in both developed and developing countries. Coronary artery bypass grafting (CABG) is a major therapy of CAD in the world, mainly used for patients with left main disease, multi-vessel complex disease, stent implantation failure, heart failure and diabetes.

Studies have demonstrated that significant angiographic defects up to 12% of grafts, which was observed by immediate coronary angiography after CABG. Despite secondary prevention were performed in patients after CABG, the early failure rate at 1 year is higher, up to 15-20%, the 10-year patency rate of internal mammary artery graft is 85%, and the 10-year patency rate of saphenous vein graft is only 61%, and 10-20% of patients require revascularization within 10 years after CABG.

Patients with failed grafts usually have a higher surgical risk and the morality of repeat CABG is 2-4 times higher than primary surgery. Because of the poor clinical prognosis of patients undergoing repeat CABG, PCI is the preferred treatment strategy for revascularization in patients with previous CABG. In patients with previous CABG, approximately 75% of PCI target vessels are native vessels.

Compared with native vessel PCI, bypass graft PCI has a higher rate of short- and long-term major adverse events, including more than double the in-hospital mortality rate. Some studies support the above view，but others denied. Therefore, the primary study mainly to explore the effect of native vessel PCI or graft PCI on the prognosis of patients with previous CABG.


Eligibility criteria: Inclusion Criteria:

* Patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting

Exclusion Criteria:

* Patients who missed follow-up data were excluded

Primary outcomes:
measure: Major adverse cardiovascular event (MACE)
timeFrame: about 10 years after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Zhijian Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488397: Tigecycline In-Vitro Surveillance Study In Taiwan
Official title: Tigecycline In-Vitro Surveillance Study In Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Infections
Keywords: Tygacil
microdilution method
Tigecycline
In-Vitro
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 7902
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital or community acquired infection

Brief summary: In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
* Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
* Within study group - Only isolates defined by the protocol are to be included.

Exclusion Criteria:

* Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
* No banked or stored isolates.
* No duplicate isolates - Only one isolate per patient is permitted.
* Outside study group - Any isolate other than those defined by protocol.

Primary outcomes:
measure: Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.
timeFrame: in vitro study therefore not applicable
measure: Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method
timeFrame: in vitro study therefore not applicable
Secondary outcomes:
measure: Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc.
timeFrame: in vitro study therefore not applicable
measure: Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.
timeFrame: in vitro study therefore not applicable
Other outcomes:
Locations:
city: Taipei
country: China
facility: Pfizer Investigational Site
state: Taiwan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02208297: Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Pain
Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 326
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: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Detailed description: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Eligibility criteria: Inclusion Criteria:

Visit 1 (Screening Visit)

* Be willing and able to comply with all treatment and follow-up/study procedures.
* Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

* Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
* Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Have known hypersensitivity or contraindication to the study drug(s) or their components.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain in the Study Eye.
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
timeFrame: 18 days
measure: Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
timeFrame: 18 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
timeFrame: 18 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
timeFrame: 18 days
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Bausch & Lomb Incorporated
state: New Jersey
Study officials:
affiliation: Valeant/Bausch & Lomb
name: Jason Vittitow
role: STUDY_DIRECTOR
References:
Clinical trial NCT02520297: A Pilot Study of TRV130 for the Treatment of Fracture Pain
Official title: A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Keywords: Pain
Long bone
Fracture
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kestrel Biologic
First posted: 2015-08-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.

Detailed description: This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years, inclusive
* Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
* Able to understand and comply with study procedures and requirements, and provide written informed consent

Exclusion Criteria:

* Significant concomitant head, chest, or abdominal trauma
* Multiple extremity trauma
* Open fracture
* Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs

Primary outcomes:
measure: Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
timeFrame: 3-hours
Secondary outcomes:
measure: Time Weighted Average Change in NPRS
timeFrame: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
measure: Time to First NPRS <= 3
timeFrame: 3-hours
measure: Safety Assessments
timeFrame: 3-hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Trevena, Inc.
state: Indiana
Study officials:
affiliation: Indiana University
name: Indiana University
role: PRINCIPAL_INVESTIGATOR
References: