louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00759447: A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
Official title: A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
tomosynthesis
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female who are undergoing screening mammography.

Brief summary: Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

Detailed description: A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Eligibility criteria: Inclusion Criteria:

* Female, any ethnic origin
* No contraindication for diagnostic mammography

Exclusion Criteria:

* Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
* Under 30 years of age at the time of consent
* Unable to understand and execute written informed consent

Primary outcomes:
measure: Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03741647: Sleep Apnea and Lung Cancer
Official title: Prognostic Significance of Sleep Apnea in Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced Non Small Cell Lung Cancer
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-11-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - patients with locally advanced non small cell lung cancer diagnosed, managed and followed up in clinical oncology department, zagazig university hospitals

Brief summary: cases of locally advanced non small cell lung cancer (diagnosed by PET/CT scan and histopathological confirmation) will be screened for sleep disorders by Epworth sleepiness scale then confirmed by full night polysomnographic study. Blood sample to detect some genetic determinants will be withdrawn


Eligibility criteria: Inclusion Criteria:

* patients with locally advanced non small cell lung cancer

Exclusion Criteria:

* unable or refuse to perform sleep study
* metastatic cases

Primary outcomes:
measure: assessment Response to treatment
timeFrame: 6 weeks from ending therapy
measure: confirmed Response to treatment
timeFrame: 4 weeks from assessment response
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 3 months from confirmed response to treatment
measure: Progression Free Survival
timeFrame: 6 months from confirmed response to treatment
measure: Progression Free Survival
timeFrame: 9 months from confirmed response to treatment
measure: Progression Free Survival
timeFrame: 12 months from confirmed response to treatment
measure: Overall survival
timeFrame: 3 months after enrollment
measure: Overall survival
timeFrame: 6 months after enrollment
measure: Overall survival
timeFrame: 9 months after enrollment
measure: Overall survival
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Ahmad Abbas
state: Asharqia
Study officials:
References:
Clinical trial NCT02201147: Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
Official title: Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Large Intestine
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.

Detailed description: Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.

The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

Eligibility criteria: Inclusion Criteria:

* patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)

Exclusion Criteria:

* patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
* known coagulopathy
* history of inflammatory bowel diseases
* American Society of Anesthesiology class III or more
* pregnancy.

Primary outcomes:
measure: complete histologic polyp eradication rate
timeFrame: 2 weeks
Secondary outcomes:
measure: rates of tissue retrieval per polyp
timeFrame: 2 weeks
Other outcomes:
measure: polypectomy procedure times
timeFrame: 2 weeks
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Bucheon
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Bong Min Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SK, Ko BM, Han JP, Hong SJ, Lee MS. A prospective randomized comparative study of cold forceps polypectomy by using narrow-band imaging endoscopy versus cold snare polypectomy in patients with diminutive colorectal polyps. Gastrointest Endosc. 2016 Mar;83(3):527-32.e1. doi: 10.1016/j.gie.2015.08.053. Epub 2015 Sep 7.
Clinical trial NCT06840847: Sexual Coercion in Breast Cancer Patients Treated With Luteinizing Hormone-Releasing Hormone Agonists (LHRHa )
Official title: Sexual Coercion in Breast Cancer Patients Treated With Luteinizing Hormone-Releasing Hormone Agonists (LHRHa )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: breast cancer
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 79
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.

Detailed description: Objective: The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.

Methods: This study is a randomized controlled study. In this study, the validated Turkish version of the Sexual Coercion in Intimate Relationship Scale was utilized to investigate whether patients receiving LHRHa therapy experienced higher rates of sexual sexual coercion compared to those taking tamoxifen. The study included 40 patients using LHRHa and 39 patients using tamoxifen. The instrument assessed partner sexual coercion across three subdomains: resource manipulation/sexual coercion, commitment manipulation, and defection threat.

Eligibility criteria: Inclusion Criteria:

* being over 18 years of age
* willingness to participate in this study
* having received treatment for breast cancer
* having a history of breast cancer surgery
* having an active relationship with a spouse or partner.

Exclusion Criteria:

* having any neuropsychiatric disorder
* having any mental illness
* having a history of gynecological surgery
* currently receiving active chemotherapy or less than 3 months since completing chemotherapy
* receiving treatment for metastatic disease
* The use of selective serotonin reuptake inhibitors

Primary outcomes:
measure: LHRHa
timeFrame: for 10 months
measure: Tamoxifen
timeFrame: for 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
state: Merkez
Study officials:
References:
Clinical trial NCT01514747: A MRI Study of Visual and Motor Pathways in Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ELBW infants with birth weight 401-1000 g (gestational age \<30 weeks)

Brief summary: Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long-term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.


Eligibility criteria: Inclusion Criteria:

* ELBW infants with birth weight 401-1000 g (gestational age \<30 weeks)

Exclusion Criteria:

* Complex congenital anomalies
* Central nervous system malformations,
* Chromosomal abnormalities, or hydrops fetalis

Primary outcomes:
measure: MRI
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
References:
Clinical trial NCT03601247: Silicone Gel for Postsurgical Scars of the Eyelid
Official title: Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring Due to Treatment
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

Detailed description: Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.

During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.

The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.

Eligibility criteria: Inclusion Criteria:

* Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.

Exclusion Criteria:

* Patients will be excluded if they require additional upper eyelid surgery.

Primary outcomes:
measure: The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Anne Barmettler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06903247: Neurosonographic Findings in Pregnant Women with Vitamin D Deficiency
Official title: Evaluation of Neurosonographic Findings in Pregnant Women with Vitamin D Deficiency
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Neurosonographic Findings of Vitamin D Deficiency
Keywords: Neurosonography Vitamin D Deficiency Pregnancy
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the Perinatology clinic of Şanlıurfa Training and Research Hospital for routine antenatal care between 20-30 weeks of gestation will be included.

Brief summary: In the study, the potential effects of vitamin D deficiency on fetal neurodevelopmental parameters will be examined. In this context, fetal brain development will be compared between pregnant women with and without vitamin D deficiency, revealing the possible neurodevelopmental outcomes of vitamin D deficiency during the prenatal period.

Detailed description: Vitamin D is a vitamin that regulates calcium and phosphorus balance in the body and plays a crucial role in bone health. Additionally, it is known to have effects on immune system functions and neurological health. Pregnancy is a period in which vitamin D requirements increase, and vitamin D deficiency can lead to various health problems. It is believed that vitamin D deficiency may have adverse effects on fetal neurological development and may be associated with certain pathological conditions during pregnancy.

Neurosonography is a critical tool for assessing the effects of prematurity, vitamin D deficiency, and other pregnancy complications on the fetus. This article will focus on the evaluation of neurosonographic findings in pregnant women with vitamin D deficiency.

Eligibility criteria: Inclusion Criteria:Patients presenting for routine antenatal care between 20-30 weeks of gestation will be included.

Exclusion Criteria:Multiple pregnancy, preterm rupture of membranes, chorioamnionitis, placental abruption, severe fetal growth restriction, congenital fetal anomalies, preeclampsia, oligohydramnios and maternal diabetes.

Primary outcomes:
measure: Pregnant women with vitamin D deficiency who present for routine antenatal care between 20-30 weeks of gestation.
timeFrame: Neurosonogram Results Performed Between 20-30 Weeks of Gestation.
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
Study officials:
References:
Clinical trial NCT02921347: Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients
Official title: Efficacy and Safety of Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Weaning
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to facilitate weaning by switching between invasive and noninvasive ventilation in difficult-weaning patients.

Detailed description: This study only enrolled patients with tracheotomy. When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.A patient in intervention group is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Eligibility criteria: Inclusion Criteria:

* duration of invasive ventilation ≥14 days
* anticipation of difficult weaning
* Glasgow Coma Scale ≥13
* no upper airway obstruction
* presence of spontaneous breath

Exclusion Criteria:

* age less than 18 or more than 85 years
* contraindications for noninvasive ventilation
* anticipation of survival less than 6 months
* refusal of tracheotomy

Primary outcomes:
measure: ventilator weaning days
timeFrame: from enrollment to 90 days
Secondary outcomes:
measure: successful weaning rate
timeFrame: from enrollment to 90 days
measure: ICU stay days
timeFrame: from admission to 90 days
measure: hospital stay days
timeFrame: from admission to 90 days
measure: ICU mortality
timeFrame: from admission to 90 days
measure: hospital mortality
timeFrame: from admission to 90 days
Other outcomes:
Locations:
city: ChongQing
country: China
facility: The first affiated hospital, chongqing medical university
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Shuliang Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03111147: Impact of Humeral Component Version on Outcomes Following RTSA
Official title: The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 95
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 proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Detailed description: Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary reverse total shoulder arthroplasty
* Diagnosis of cuff tear arthropathy or primary OA with RCT
* Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
* 18 years or older

Exclusion Criteria:

* Revision arthroplasty
* Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
* Minors (under 18 years of age)

  * Prior open shoulder surgery
  * Concomitant latissimus dorsi transfer
  * Patients not undergoing a standard of care physical therapy protocol
  * Pregnant, patient-reported
  * Cognitively impaired

Primary outcomes:
measure: Postoperative External Range of Motion (ROM)
timeFrame: 2 years
measure: Postoperative Internal Range of Motion (ROM)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: J. Michael Wiater, MD
role: PRINCIPAL_INVESTIGATOR
References: