louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05943873: Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
Official title: Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Breast Cancer
Keywords: free flap
breast reconstruction
minimally invasive mastectomy
nipple-sparing mastectomy
robotic-assisted mastectomy
endoscopic-assisted mastectomy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 63
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon

Brief summary: A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.


Eligibility criteria: Inclusion Criteria:

* patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.

Exclusion Criteria:

* patients failed to be examined for outcome evaluation will be excluded from the study.

Primary outcomes:
measure: Successful
timeFrame: post-operative 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
Study officials:
References:
Clinical trial NCT03735173: Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Official title: Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy Shoulder
Shoulder Pain
Shoulder Osteoarthritis
Shoulder Arthritis
Shoulder Arthropathy Associated With Other Conditions
Necrosis of Bone
Arthritis
Inflammatory Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.


Eligibility criteria: Inclusion Criteria:

* Subjects willing to sign the informed consent
* Male and female subjects ages 18 - 90 at the time of surgery
* Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)

Exclusion Criteria:

* Inability to comply with follow-up requirements
* Known or presumed substantial rotator cuff disorders
* Subjects with an active or suspected latent infection in or about the shoulder
* Subjects with instability (surgically or non-surgically addressed)
* Subjects presenting with posttraumatic avascular necrosis
* Need for glenoid bone grafting
* Pregnant subjects

Primary outcomes:
measure: Function of Subscapularis muscle as measured by belly-press test
timeFrame: 5 years
measure: Radiographic loosening
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Morrey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002273: Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial
Official title: The Effect of Regulated Pleural Pressure on The Duration of Air Leak and Fluid Drainage Following Pulmonary Anatomic Resections: A Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Ospedali Riuniti Ancona
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: Yale University
name: The University of Hong Kong
First posted: 2013-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure.

In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.


Eligibility criteria: Inclusion Criteria:

* Able and willing to read, understand, and provide written Informed Consent;
* Age range of 18-90 years;
* Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable.

Exclusion Criteria:

* if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis
* If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis.
* If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Primary outcomes:
measure: duration of air leak
timeFrame: up to 7 days
Secondary outcomes:
measure: 1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups
timeFrame: up to 5 days
measure: Differences in fluid drainage
timeFrame: up to 5 days
measure: Duration of chest tube left in the patient (days)
timeFrame: up to 7 days
measure: Postoperative length of hospital stay (days)
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti Ancona
Study officials:
References:
Clinical trial NCT03022773: Macular Pigment Measurements in Eye & Other Tissues
Official title: Macular Pigment Measurements in Eye & Other Tissues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Pigmentation
Skin Pigment
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. The investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue.

A secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.

Detailed description: The macula of the human retina (the structure responsible for high acuity vision essential for reading, driving and recognizing faces) is colored an intense yellow due to the deposition of two carotenoid compounds, lutein and zeaxanthin. These xanthophyll carotenoids are derived exclusively from the diet, and are hypothesized to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties.

Epidemiological studies have shown that high dietary intake and blood levels of lutein and zeaxanthin are associated with lower rates of vision loss due to age-related macular degeneration (AMD).

It is of interest to correlate carotenoid levels in the eye and skin tissues with blood levels of carotenoid compounds.

Eligibility criteria: Inclusion Criteria:

* Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the Moran Eye Center will be eligible to participate.
* Patients with adult vitelliform dystrophy. (This condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (AMD)).

Exclusion Criteria:

* Patients under age 7 will not be eligible to participate.

Primary outcomes:
measure: Carotenoid levels in the eye
timeFrame: at enrollment
measure: Carotenoid levels in the skin
timeFrame: at enrollment
Secondary outcomes:
measure: Carotenoid levels in the blood
timeFrame: at enrollment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah John A. Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Paul Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853073: Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
Official title: Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glaucoma
Keywords: failing blebs
failing express shunt
avastin
bevacizumab
glaucoma
prior trabeculectomy
Express shunt placed under a scleral flap
subsequent filtration failure
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 63
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 purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Detailed description: To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Eligibility criteria: Inclusion Criteria:

* require glaucoma bleb needle revision with Mitomycin-C

Exclusion Criteria:

* pregnant, nursing, or not using adequate contraception
* other glaucoma eye surgery involving tube shunts
* prior retinal detachments surgery with scleral buckle
* infection, inflammation, or any abnormality preventing eye pressure measurement
* enrolled in another investigational study

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Surgical Success
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute, Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye
name: Marlene R Moster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tai TY, Moster MR, Pro MJ, Myers JS, Katz LJ. Needle bleb revision with bevacizumab and mitomycin C compared with mitomycin C alone for failing filtration blebs. J Glaucoma. 2015 Apr-May;24(4):311-5. doi: 10.1097/IJG.0b013e31829f9bd3.
Clinical trial NCT02046473: 3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Official title: 3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Liver Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

Detailed description: To determine if 3D ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. This has been done in order to reduce portal vein pressure. These shunts are known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

Eligibility criteria: Inclusion Criteria:

1. Male and female 18 years of age and older
2. Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
3. Have an ultrasound ordered by your physician to evaluate your TIPS.
4. Able to read, understand and sign informed consent

Exclusion Criteria:

1. Under 18 years of age
2. Cannot be pregnant

Primary outcomes:
measure: Estimate portal blood flow within a transjugular portosystemic shunt
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Paula Novelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278573: Intralesional Vitamin D Injection for Treatment of Common Warts
Official title: Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 77
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: Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients seen at the Mayo Clinic Rochester practices
* Patients suffering from one or more cutaneous warts as diagnosed by the examining physician at baseline visit on typical diagnostic characteristics
* Able to provide consent
* Both recalcitrant and non-recalcitrant warts will be included

Exclusion Criteria:

* Patients with prior use of home or office-based destructive treatments for this wart(s) in the last 1 month with salicylic acid (SA) or cryotherapy
* Immunoadjuvant therapy for warts in the last 4 months (e.g Candida)
* History of vitamin D injection of warts ever
* High-dose vitamin D supplementation (\>4,000 IU daily or equivalent) in the preceding 3 months
* Pregnancy or lactation
* Facial or genital warts
* Lesions not felt by the examining clinician to be a wart (e.g., corns or calluses)
* Immunosuppression (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit).
* Allergy to sesame oil

Primary outcomes:
measure: Complete Regression of Wart
timeFrame: 24 weeks
Secondary outcomes:
measure: Regression of Wart at 4 Weeks
timeFrame: 4 weeks
measure: Regression of Wart at 8 Weeks
timeFrame: 8 weeks
measure: Regression of Wart at 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Merry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103973: The Impact of Distress on the IVF Outcome
Official title: The Impact of Distress on the IVF Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF, Mind/Body
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 143
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).

This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* Female Boston IVF infertility patient
* Age 21-40 years
* Day 3 FSH level 12 mIU/ml or below
* Day 3 E2 level 80 pg/ml or below
* Using own eggs (not an egg donor)
* Daily access to the internet
* Able to read, understand, and sign the informed consent in English

Exclusion Criteria:

* Prescription antipsychotic medication
* Diagnosis of borderline or narcissistic personality disorder
* Previous participation in a MB group

Primary outcomes:
measure: Clinical Pregnancy Rates
timeFrame: 1 year
Secondary outcomes:
measure: Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
timeFrame: 1 year
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Alice D Domar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.
Clinical trial NCT00092573: Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)
Official title: Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hypertriglyceridemia
Keywords: Mixed hyperlipidemia (high cholesterol and high triglycerides)
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed description: The duration of treatment is 48 weeks.

Eligibility criteria: Inclusion Criteria:

* High cholesterol and high triglycerides

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Primary outcomes:
measure: Tolerability
Secondary outcomes:
measure: Plasma LDL-C, HDL-C and triglycerides after 12 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.
citation: McKenney JM, Farnier M, Lo KW, Bays HE, Perevozkaya I, Carlson G, Davies MJ, Mitchel YB, Gumbiner B. Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. J Am Coll Cardiol. 2006 Apr 18;47(8):1584-7. doi: 10.1016/j.jacc.2005.11.072. Epub 2006 Mar 30.
citation: Tribble DL, Farnier M, Macdonell G, Perevozskaya I, Davies MJ, Gumbiner B, Musliner TA. Effects of fenofibrate and ezetimibe, both as monotherapy and in coadministration, on cholesterol mass within lipoprotein subfractions and low-density lipoprotein peak particle size in patients with mixed hyperlipidemia. Metabolism. 2008 Jun;57(6):796-801. doi: 10.1016/j.metabol.2008.01.026.
citation: Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212. doi: 10.1186/1476-511X-10-212.