louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01086241: Tomosynthesis in Screening Mammography
Official title: A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Density >25%
Keywords: Tomography
Mammography
Breast Neoplasms
Prevention and Control
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2010-03-15
Enrollment: 500
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.

Detailed description: We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped \< 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

Eligibility criteria: Inclusion Criteria:

* Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
* Prior mammogram report indicating ≥ 25% breast density.

Exclusion Criteria:

* Prior mammogram report indicating \<25% breast density.
* Breast implants
* Pregnancy

Primary outcomes:
measure: Interpretation Time of Scan
timeFrame: Within 1 month of receiving scan
Secondary outcomes:
measure: Recall Rates
timeFrame: 6 month intervals for 2 years after initial scan
measure: Discomfort Scale
timeFrame: Immediately after the subject receives scan
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Screen Test
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Aalo Bistritz, MD
role: STUDY_CHAIR
affiliation: Cross Cancer Institute
name: Aalo Bistritz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750841: Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
Official title: A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Keywords: advanced cancer
metastatic
rifampicin
pharmacokinetics
Phase I
Advanced solid tumours
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
* Estimated life expectancy of at least 8 weeks
* WHO performance status (PS) 0-2.

Exclusion Criteria:

* Unstable brain/meningeal metastases
* Biochemistry/haematology results outside of required ranges
* History of significant GI impairment
* Inadequate bone marrow reserve

Primary outcomes:
measure: To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin
timeFrame: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.
Secondary outcomes:
measure: To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram.
timeFrame: Until study drug is discountinued
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Cross Cancer Institute, Edmonton, AB, Canada
name: Michael Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297541: Healthy Kids I-PAL
Official title: Healthy Kids at I-PAL (Interactive Physical Activity Lab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Southeastern Louisiana University
First posted: 2017-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.


Eligibility criteria: Inclusion Criteria for Child:

* Have at least one participating parent
* Be physically capable of exercise
* Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer

Inclusion Criteria for Parent:

* Have a smart phone
* Be willing to use the smartphone for the mHealth intervention

Exclusion Criteria for Child:

* Significant cardiovascular disease or disorders via self-report from parent
* Other significant medical problems that would prevent them from engaging in regular physical activity.

Primary outcomes:
measure: Child Acceptability of the mHealth Approach
timeFrame: 13 Weeks
Secondary outcomes:
measure: BMI Z-score Change
timeFrame: Week 0 to Week 14-16
Other outcomes:
Locations:
city: Hammond
country: United States
facility: Southeastern Louisiana University
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Amanda Staiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Corby Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.
Clinical trial NCT00323141: Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
Official title: Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Umbilical
Keywords: Hernia umbilicalis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.


Eligibility criteria: Inclusion Criteria:

* Symptomatic hernia umbilicalis
* \> 18 years old

Exclusion Criteria:

-

Primary outcomes:
measure: Number of relapses after 1 and 3 years
timeFrame: after 1 and 3 years
Secondary outcomes:
measure: Duration of surgery
timeFrame: Depends from type of surgery.
measure: Duration of hospitalisation
timeFrame: Depends from type of surgery.
measure: Frequency of complications
timeFrame: After 1 and 3 years.
measure: Pain assessment
timeFrame: After 1 and 3 years.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815541: Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
Official title: Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarticular Infection
Keywords: subcutaneous teicoplanin
osteoarticular
infections
tolerance
teicoplanin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years
* Inpatient orthopedic surgery
* Achieved a bone and joint infection documented gram + (staphylococci golden coagulase-negative staphylococci, enterococci, streptococci)
* Bacteria resistant to lincosamides, quinolones and rifampicin
* Bacteria susceptible to teicoplanin (MIC ≤ 4 mg / L)
* Balanced patient teicoplanin administered intravenously (2 successive doses between 30 and 40 mg / mL)

Exclusion Criteria:

* Patient not affiliated to the social security
* Pregnant and lactating women
* Known hypersensitivity to teicoplanin (rash, ...)
* Patients with a central catheter or an implantable chamber
* Patient hemodialysis
* Patient has another participant biomedical research on a drug to prevent drug interactions
* Patient minor
* Patient major protected (protection of the court, wardship, trusteeship)
* Patient admitted for emergency or incapable of consent

Primary outcomes:
measure: measure of tolerance
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens, France
name: Youssef El SAMAD, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00838019: Intrabone Cord Blood Transplantation
Official title: Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hematological Malignancies
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Hematological malignancies
* Indication of allogenic transplantation
* No suitable donor (related/unrelated)
* No suitable cord blood unit with enough cellularity for standard transplant
* Written informed consent

Exclusion Criteria:

* ECOG \> 2
* Co-morbidities
* HIV positive serology
* Pregnancy or breastfeeding
* Psychiatric illness

Primary outcomes:
measure: Kinetics of hematopoietic engraftment
timeFrame: days 14, 21, 28 after administration
Secondary outcomes:
measure: Dynamics and chimerism of hematological engraftment
timeFrame: days 14, 21, 28 after administration
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BMT Unit Hematology Department Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Montserrat Rovira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738919: Extension Block Technique Versus Splinting in Mallet Finger Fracture.
Official title: Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mallet Finger
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture.

Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique.

The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates.

The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Mallet finger fractures with a \>1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
* Fractures with a delay of \< 2 weeks.
* With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.

Exclusion Criteria:

* Open injuries
* Mallet finger fracture of the thumb
* Co-existing rheumatologic illness in the fingers
* No-compliance patient

Primary outcomes:
measure: Extension Deficit in the Affected Distal Interphalangeal Joint.
timeFrame: 6 month
Secondary outcomes:
measure: Pain
timeFrame: 6 month
measure: Bump
timeFrame: 6 month
measure: Complications
timeFrame: 6 month
measure: DASH
timeFrame: 6 month
measure: Flexion of the Distal Interphalangeal Joint.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hand Surgery, Aarhus University Hospital
Study officials:
affiliation: Department of Hand Surgery, Aarhus University Hospital, Denmark
name: Bo Munk, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03444519: The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours
Official title: Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supratentorial Tumors
Keywords: brain relaxation
mannitol
supratentorial tumours
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although mannitol is used for brain relaxation during neurosurgery and in the treatment of raised intracranial pressure; there is not a consensus on its safe, effective dose and the duration of its administration. This study aimed to compare the effects of the mannitol in different use times, on the brain relaxation, electrolyte, lactate levels of the blood, peroperative fluid balance and the volume of the urine in supratentorial mass resection surgeries.


Eligibility criteria: Inclusion Criteria:

* Intracranial shift \>3mm
* Scheduled for supratentorial mass resection under elective conditions

Exclusion Criteria:

* Decompensated heart failure
* kidney insufficiency
* Diabetes insipidus,
* Electrolyte imbalance and
* Who are unconscious

Primary outcomes:
measure: brain relaxation score
timeFrame: just before dural opening
Secondary outcomes:
measure: Blood sodium levels
timeFrame: change in 30 minute intervals in the first 2 hour after study drug administration
measure: Blood potassium levels
timeFrame: change in 30 minute intervals in the first 2 hour after study drug administration
measure: Blood chlorine levels
timeFrame: change in 30 minute intervals in the first 2 hour after study drug administration
measure: Blood lactate levels
timeFrame: change in 30 minute intervals in the first 2 hour after study drug administration
measure: Fluid balance during operation
timeFrame: change in 30 minute intervals in the first 2 hour after study drug administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University affiliated Huashan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02260219: Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma
Official title: Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neovascular Glaucoma
Keywords: Ahmed implant
Neovascular Glaucoma
Intraocular pressure
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 42
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: Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.

Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of Neovascular glaucoma
* High IOP despite topical treatment

Exclusion Criteria:

* Pregnant women
* Mental disorders
* Previous glaucoma surgery
* Patients older than 18 years

Primary outcomes:
measure: Number of participants with adverse effects
timeFrame: 1 year
Secondary outcomes:
measure: Intraocular pressure
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: 52 55 10841400
name: Felix Gil-Carrasco, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00541619: Sympathetic Overactivity in Essential Hypertension
Official title: Sympathetic Overactivity in Essential Hypertension
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Proteinuria
Keywords: hypertension
sympathetic activity
early renal damage
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary hypertension.

Brief summary: The primary objective of the study is whether subjects with hypertension and proteinuria display increased sympathetic nerve activity compared to hypertensive subjects without proteinuria and normotensive controls.


Eligibility criteria: Inclusion Criteria:

* Normotension or hypertension

Exclusion Criteria:

* Pregnant and nursing women
* Myocardial infarction, clinical signs of coronary heart disease
* Severe depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Nephrology and Hypertension, Clinical Research Center
state: Bavaria
Study officials:
affiliation: Principal Investigator
name: Roland Veelken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06658119: Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial
Official title: Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Keywords: cataract surgery
intraocular lens
extended depth-of-focus
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.


Eligibility criteria: Inclusion Criteria:

* age-related cataract patients aged between 40 to 80
* patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
* patients who plan to receive femtosecond laser-assisted cataract surgery

Exclusion Criteria:

* patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
* patients with history of ocular trauma or surgery
* patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
* patients with concurrent severe systemic diseases
* patients who lack of cooperation

Primary outcomes:
measure: Visual acuity
timeFrame: 1 day, 1 week, 1 month, 3 months postoperatively
Secondary outcomes:
measure: Visual quality
timeFrame: 3 months postoperatively
measure: defocus curve
timeFrame: 3 months postoperatively
measure: contrast sensitivity
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye Center of the Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: