louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05390229: Screening Contrast-enhanced Mammography
Official title: Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion At Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the breast clinic at the HSS for a mass suspected of cancer (BIRAD 5) will potentially be considered in the study. These women come either from the Quebec breast cancer screening program, or referred by their attending physician in the investigation of a palpable/symptomatic mass or in an investigation requested for a high-risk patient. These patients will then be referred to us by the attending surgeons as part of the preoperative evaluation of the lesion. Preoperatively, mammography (standard or by tomosynthesis) is considered standard and MRI can also be requested as standard by the surgeon. The patients included will be those for whom an MRI will be prescribed. All patients will receive diagnostic imaging (CESM, MRI and TMN) within 30 days of surgery.

Brief summary: The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.


Eligibility criteria: Inclusion Criteria:

* Female aged 18 and over
* At least one breast lesion with BIRADS classification 5

Exclusion Criteria:

* Refusal to perform the biopsy or surgery
* Pregnant or possibly pregnant woman
* Usual contraindication to contrast product

  * Significant kidney failure
  * Allergy to contrast medium
* hyperthyroidism
* Usual contraindications to MRI

Primary outcomes:
measure: Diagnostic value for breast cancer
timeFrame: Breast cancer screening
measure: Diagnostic value for suspicious breast lesion
timeFrame: Breast cancer screening
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: St-Sacrement Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT05663229: Postural Analysis of Patients Receiving Rehabilitation Program
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stability
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with physical disability followed-up in rehabilitation department

Brief summary: This is a study for evaluation of posture of patients with neurological disease in rehabilitation department.

Detailed description: In this study, we evaluate the static posture stability of the patient, such as during sitting, standing and dynamic posture stability of the patient, such as during walking, time-up-and-go test.

Eligibility criteria: Inclusion Criteria:

* Patient with physical disability followed-up in rehabilitation department

Exclusion Criteria:

* Patients with congitive impairment that can't complete the evalaution well
* Patients with uncontrolled comorbidity diseases
* Attended other study in recent 3 months

Primary outcomes:
measure: Displacement of center of gravity during standing
timeFrame: 1 day
measure: Displacement of center of gravity during walking
timeFrame: 1 day
Secondary outcomes:
measure: Trunk movement
timeFrame: 1 day
measure: Hip movement
timeFrame: 1 day
measure: Knee movement
timeFrame: 1 day
measure: Ankle movement
timeFrame: 1 day
measure: Foot pressure
timeFrame: 1 day
measure: Foot reaction force
timeFrame: 1 day
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: aohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Yu Hsuan Tseng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044329: Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion
Official title: Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Branch Retinal Vein Occlusion
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Labbafinejad Medical Center
First posted: 2010-01-07
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.


Eligibility criteria: Inclusion Criteria:

* Recent onset (less than 3 months) BRVO

Exclusion Criteria:

* Any previous intervention

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: central macular thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Hossein medical center
Study officials:
References:
Clinical trial NCT04075929: Short or Long High Intensity Training
Official title: Aerobic Short or Long High Intensity Interval Training - Does it Matter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Performance
Cycling
Well-trained Athletes
Keywords: Cycling
endurance performance
intermittent exercise
maximal oxygen consumption
physiological adaptions
well-trained athletes
Lead sponsor: University of Agder
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the effects of short and long high intensity interval training (HIT) conducted with the same total accumulated duration on physiological- and performance parameters during a 4-week training period.

Detailed description: Studies among elite athletes have documented the importance of large amounts of training volume in order to perform at a high level in endurance sports. It is also well documented that both low intensity training (LIT), moderate intensity training (MIT) and high intensity training (HIT) should be included in the overall training efforts. It is well documented that HIT has a positive effect on the aerobic endurance among both elite athletes and recreational athletes.

Despite the fact that there is general agreement that HIT is an important part of the overall training, it is unclear how this part of the training should be organized in order to optimize the training effects. The adaptions of endurance performance seem to depend on both the intensity and the accumulated duration of the HIT sessions. Therefore, the aim of this study was to compare the effects of SI and LI training, including equal accumulated HIT duration, during a 4-week intervention period, conducted as 4x8-min with 2-min recovery periods, 4x(12x40/20-sec) with 2-min recovery periods and 4x(8x40/20-sec) with 2-min recovery periods, in different physiological- and performance parameters among well-trained cyclists.

Eligibility criteria: Inclusion Criteria:

* male \< 40 years,
* peak oxygen uptake (VO2peak) \> 55 ml.kg-1.min-1,
* training volume \>3 sessions per week (within cycling)
* absence of disease and injuries.

Exclusion Criteria:

* disease/injuries
* frequent absence of HIT sessions during the period.

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional threshold power
timeFrame: 4 weeks
measure: Peak power output
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: University of Agder
Study officials:
affiliation: Universitetet i Agder
name: Monica K. Torstveit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573529: EDOF and Multifocal IOL Study
Official title: Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cataract
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intra-individual comparison of two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
Primary purpose: TREATMENT

Brief summary: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50-90
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
* Uncontrolled systemic or ocular disease

Primary outcomes:
measure: distant corrected near visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Binocular Uncorrected Near Visual Acuity
timeFrame: 3 years
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT03193229: MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
Official title: MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Obesity
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-20
Enrollment: 430
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching objective of our work is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a text-messaging based intervention.

Detailed description: This study will randomize participants to 2 groups, an intervention group that will receive a Fitbit and MapTrek, and a control group that will receive a Fitbit only. This study has 3 specific aims.

Aim 1- To determine if patients randomized to MapTrek walk more than the control patients.

Aim 2- To determine if patients randomized to MapTrek generally walk at a faster pace during the day than control patients.

Aim 3- To determine if patients randomized to MapTrek have less sedentary time during the day than the control patients.

We expect to collect sufficient data to demonstrate the effectiveness of MapTrek, our prototype m-health tool, as an intervention to increase physical activity, heighten intensity of activity, and reduce sedentary behavior among a cohort of patients at risk for type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* At least 21 years old
* English speaker
* Have a smart phone with texting and internet capabilities
* No aversion to research studies
* No active mental health conditions
* 1) Have a BMI \> or equal to 25 and a history of hemoglobin A1C level between 5.7 and 6.4%, or 2) have a BMI \> or equal to 30.

Exclusion Criteria:

* Pregnancy
* Prisoner status
* Taking insulin or other diabetic medications

Primary outcomes:
measure: Total number of steps per day
timeFrame: 6 months
Secondary outcomes:
measure: Pace of steps per day
timeFrame: 6 months
Other outcomes:
measure: Sedentary minutes per day
timeFrame: 6 months
Locations:
city: Coralville
country: United States
facility: Signal Center Innovation Lab
state: Iowa
Study officials:
affiliation: Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation
name: Phil Polgreen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549429: Tegaderm vs. EyeGard for Eye Protection
Official title: A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Tufts University
First posted: 2018-06-08
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Every patient will have each tape on each eye -EyeGard® on one eye and the TegadermTM on the other eye according to the randomization schema.
Primary purpose: PREVENTION

Brief summary: This study compares TegadermTM and EyeGard® in general anesthesia.

Detailed description: Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Surgeries scheduled for anesthesia of any duration

Exclusion Criteria:

* Any patient that does not consent
* Any patient who has:
* Pre-existing eyelid erythema or other eyelid trauma
* Eyelid piercings
* Any surgery on the head, brain, neck, teeth, mouth, eyes or face
* Surgery in the prone position
* Patients \<18 years old

Primary outcomes:
measure: Proportion of Participants With Eyelid Erythema
timeFrame: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: post-operation
measure: Rate of Corneal Abrasions
timeFrame: post-operation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center Dept. of Anesthesia
name: Dan Drzymalski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drzymalski DM, Ward K, Hernandez JM, Hoot J, Au SC, Yang FC, Azocar RJ. The effect of Tegaderm versus EyeGard(R) on eyelid erythema during general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):560-567. doi: 10.1007/s12630-020-01588-6. Epub 2020 Feb 13.
Clinical trial NCT00960180: Study Evaluating Single Ascending Doses of MR1817
Official title: A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.


Eligibility criteria: Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening.

2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.

Primary outcomes:
measure: Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests
timeFrame: 6 weeks
Secondary outcomes:
measure: MR1817 plasma and urine concentration.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
Study officials:
affiliation: Fulcrum Pharma (Europe) Ltd
name: Robert Miller
role: STUDY_DIRECTOR
References:
Clinical trial NCT00949780: Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
Official title: Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Auditory Brainstem Response in Children
Sedation With Chloral Hydrate
Keywords: ABR
Chloral Hydrate
Sedation
Children
Lead sponsor: Pontificia Universidade Catolica de Sao Paulo
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 41
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in pediatric and dental procedures owing to the low depressive effect it has over respiratory and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and sudden death in children, especially when using high doses, probably due to accumulation of serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the drug. A possible carcinogenic action observed in guinea pigs has also been reported, even though it has not been confirmed in human beings.

Among the least severe complications there are paradoxical agitation, nausea, vomiting and excessive sleepiness.

CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test (ABR), in which any movement or muscle contraction may generate artifacts that interfere in the analysis.

Profound sleep that lasts on average one hour is rapidly induced depending on the used dose, causing no residual sleepiness after this period; however, there is consensus in the literature about the best dose, which may range from 40 to 100 mg/kg.

Objective:

To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.


Eligibility criteria: Inclusion Criteria:

* no success in previous attempts to perform the test during natural sleep

Exclusion Criteria:

* severe heart or lung disease

Primary outcomes:
measure: 36 patients slept
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Mariana Lopes Favero
city: São Paulo
country: Brazil
facility: Derdic-Pucsp
Study officials:
References:
Clinical trial NCT05306080: Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
Official title: Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: CRS - Cytokine Release Syndrome
HLH
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-03-31
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: TREATMENT

Brief summary: This is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).

Detailed description: This pilot, open-label trial will allow for co-enrollment of subjects participating in University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell studies. As utilization of this investigational drug may be required emergently in the event of qualifying safety events post CAR T cell infusion, subjects may be consented/enrolled at the time they receive an investigational CAR T cell product. If/when use of this investigational drug is deemed clinically necessary, rescue therapy may then be initiated.

Cohort 1: Will allow for the use of Tadekinig alfa, an interleukin-18 binding protein that binds and neutralizes IL-18. IL-18 is a key mediator in systemic inflammatory conditions such as MAS/HLH, which may contribute to the severity of CAR T cell-related cytokine release syndrome (CRS) and HLH-like syndrome (CRHLS) and impact response to standard therapy. In addition, subjects experiencing other IL-18 driven toxicity post CAR T cell therapy which is non-responsive to conventional treatment may also receive rescue therapy with Tadekinig alfa as per clinical discretion.

Eligibility criteria: Inclusion Criteria:

1. Signed, written informed consent
2. Male or female patients age ≥ 18 years
3. Have been co-enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial.
4. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria:

1. Pregnant or nursing (lactating) women.
2. Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).

Primary outcomes:
measure: Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: