louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067583: A Follow-up Physician Survey to Evaluate Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe
Official title: Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmology, Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 454
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Countries included are France, Germany, Italy, Spain, and the United Kingdom.

Brief summary: With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.


Eligibility criteria: Inclusion Criteria:

* Has signed informed consent
* Is a licensed and practicing ophthalmologist
* Has prescribed and/or administered aflibercept to at least one patient in the past 6 months

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of physicians responding correctly to each individual knowledge question
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References:
Clinical trial NCT03747783: Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer
Official title: Development and Validation of Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer: a Single-institutional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Cancer
Keywords: Survival
Nomograms
Laryngeal cancer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: laryngeal carcinoma patients with radical surgery

Brief summary: Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study,the investigators sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

Detailed description: Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)

Eligibility criteria: Inclusion Criteria:

* laryngeal carcinoma patients with radical surgery

Exclusion Criteria:

* multiple primarry malignant neo-plasms

Primary outcomes:
measure: Overall survival
timeFrame: Follow up 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Genglong Liu
state: State...
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Xiaojun Tan
role: STUDY_CHAIR
References:
Clinical trial NCT04981483: Conservative Surgery for Placenta Accreta
Official title: Long-term Follow-up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A stepwise surgical approach for conservative management of placenta previa accreta.

Detailed description: a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.

Eligibility criteria: Inclusion Criteria:

* Any age.
* Any parity.
* Previous one or more cesarean delivery.
* Placenta previa accreta diagnosis confirmed by gray scale \& color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S

Exclusion Criteria:

* women with medical disorder
* women with bleeding tendency

Primary outcomes:
measure: incidence rate of conserving woman's uterus
timeFrame: intraoperative
Secondary outcomes:
measure: number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin
timeFrame: till 48 hours postpartum
measure: incidence rate of cesarean hysterectomy needed
timeFrame: intraoperative and 48 hours postpartum
measure: incidence of puerperal sepsis
timeFrame: till 6 weeks postpartum
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: ainshams university faculty of medicine
name: mahmoud ghaleb, lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01675583: Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
Official title: Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Keywords: Diabetic Wounds
Hyperbaric Oxygen
Laser Speckle Imaging
Hyperbaric Oxygenation
Lead sponsor: CW Optics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have chronic lower extremity wounds will be recruited from the patient population at Winchester Medical Center for enrollment in the study.

Brief summary: The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.


Eligibility criteria: Inclusion Criteria

* Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:

  * Necrotizing fasciitis
  * Compromised/failed skin grafts/flaps
  * Chronic refractory osteomyelitis
  * Soft tissue radiation necrosis
  * Diabetic wounds, lower extremity
  * Acute peripheral arterial insufficiency
  * Crush injury
  * Venous leg disease
  * Pressure ulcer
  * Other chronic, non-healing wounds
* Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

* Female subjects who are pregnant or nursing.
* Anyone who is unable to give written informed consent
* Subjects with end-stage renal disease or who require peritoneal or hemodialysis.
* Subjects with current malignancies.

Primary outcomes:
measure: Blood flow velocity measurements
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT02615483: Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
Official title: Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Fusion
Anxiety
Depression
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to investigate the effect of a Web- based Platform (WP) on anxiety and depression and health economics among patients undergoing lumbar spine fusion (LSF).

Detailed description: This study will seek to reduce pre- and postoperative anxiety, depression and functional impairments using alternative cognitive and educative methods, targeting the underlying factors for development of anxiety and depression.

It is known that there is a rationale behind using Cognitive Behavioural Therapy (CBT) in order to reduce pre- and postoperatively anxiety and depression. The main assumption within CBT is that patients´ perceptions create their thoughts and beliefs, which influence their feelings and subsequently their behaviour. The features of WP in this study will seek in several ways to exceed this expected behaviour modification. The preliminary choices of features on the WP are made in order to prevent catastrophic images and thereby reduce anxiety and depression. The WP will offer patients non-catastrophic images through animated information mirroring the course of treatment, which will aim to influence their beliefs, feelings and their behaviour.

To examine the effect of the WP versus conventional information and course of rehabilitation, on patients' degree of anxiety and depression, a randomized controlled trial will be preformed. A total of 114 patients scheduled for elective instrumented LSF will be included and randomly assigned to the control group or to the intervention group receiving access to the WP.

Eligibility criteria: Inclusion Criteria:

* Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion

Exclusion Criteria:

* Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.

Primary outcomes:
measure: Anxiety and Depression
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Functional outcome
timeFrame: 3, 6,12 months after surgery
measure: Self-perceived health status
timeFrame: 3, 6, 12 months after surgery
measure: Back and leg pain
timeFrame: 3, 6, 12 months after surgery
measure: Anxiety and Depression
timeFrame: 6, 12 months after surgery
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Centre og Elective Surgery, Regional Hospital Silkeborg
Study officials:
affiliation: Institute of Publich health, Aarhus University
name: Claus V. Nielsen, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342783: Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma
Official title: Next Generation Sequencing of Childhood Soft Tissue Sarcomas to Identify Drivers of Primary and Metastatic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-04-27
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COG-D9902 soft tissue sarcoma biology and banking study participants.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.

Detailed description: OBJECTIVES:

* To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
* To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.

OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
* Rhabdomyosarcoma, NOS

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: British Columbia Cancer Agency
name: Poul Sorensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753583: High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
Official title: High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Abrasions
Corneal Infiltrates
Keywords: optical coherence tomography
corneal abrasion
corneal infiltrate
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. The present study has the character of a pilot study and the results are intended to be used to develop a standardized protocol for imaging and analysis of these corneal lesions. Based on this protocol, further studies investigating the pathophysiology of corneal lesions or evaluating therapeutic success can be planned.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Newly diagnosed corneal abrasion or corneal infiltrate

Exclusion Criteria:

* Recurrent corneal erosion
* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Any contraindication for topical application of Novain 0.4% eye drops for topical anesthesia or of Minims-Fluorescein Sodium eye drops for fluorescein staining
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Imaging of corneal abrasions and infiltrates
timeFrame: 1 day
Secondary outcomes:
measure: Size and depth of corneal lesions as assessed with high-resolution OCT
timeFrame: 1 day
measure: Slit lamp biomicroscopy with fluorescein staining
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT01644383: Meaning of Life in HIV-infected Youths
Official title: Meaning in Life of Youth Infected With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meaning of Life
Keywords: meaning of life
logotherapy
HIV-infected teenagers
adherence
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Pediatric department, Chulalongkorn University, Bangkok, Thailand
name: SEARCH Research Foundation
name: Wayne State University
name: University of Minnesota
First posted: 2012-07-19
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Logotherapy has never been evaluated in HIV-infected teenagers. In this study, we will evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn Memorial Hospital.

Detailed description: In the HAART era, HIV infected children can live longer and will grow up to become teenagers. However, some may develop psychosocial problems because they have lost family members, experienced poverty, social discrimination etc. Being a normal teenager is tough and is the most complex period of his/her life. This is the period when most teenagers will find their identity and reasons for living. Therefore it is believed that interventions may help HIV-infected teenagers better deal with life. For this study, logotherapy, a therapy that will help a person to discover his/her purpose in life, live meaningful life, and attain self-esteem was used. The success of the intervention was evaluated by using The Purpose in Life Test.

Eligibility criteria: Inclusion Criteria:

1. Age 16-24 years
2. HIV seropositive
3. HIV disclosed
4. Understand Thai language
5. Parent signed written informed consent

Exclusion Criteria:

1. Mental or psychological disorder or having active suicidal idea or attempt
2. Having no permanent address

Primary outcomes:
measure: PIL score
timeFrame: week 48
Secondary outcomes:
measure: QOL
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT, the Thai Red Cross AIDS Research Centre
Study officials:
affiliation: Chulalongkorn University
name: Arunya Tuicomepee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00482183: Comparison Between Pioglitazone and SES With type2 DM
Official title: Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Type 2 Diabetes Mellitus
Keywords: Bare metal stent
Major adverse cardiac events
Pioglitazone
Restenosis
Sirolimus eluting stent
Lead sponsor: Showa University
Sponsor class: OTHER
First posted: 2007-06-05
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.

Detailed description: The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.

Exclusion Criteria:

* spastic angina pectoris
* congestive heart failure
* hepatic dysfunction
* chronic renal disease
* recent stroke
* impaired glucose tolerance
* insulin dependent diabetes mellitus
* familial hypercholesterolemia
* thyroid dysfunction
* adrenal dysfunction
* an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.

Primary outcomes:
measure: The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
timeFrame: Within 12minths after the procedure
Secondary outcomes:
measure: Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.
timeFrame: 6 months after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Showa University
name: Youichi Kobayashi, Professor
role: STUDY_CHAIR
References:
citation: Nishio K, Shigemitsu M, Kodama Y, Konno N, Katagiri T, Kobayashi Y. Comparison of bare metal stent with pioglitazone versus sirolimus-eluting stent for percutaneous coronary intervention in patients with Type 2 diabetes mellitus. Cardiovasc Revasc Med. 2009 Jan-Mar;10(1):5-11. doi: 10.1016/j.carrev.2008.06.004.