louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04410393: Sacrocolpopexy and Lateral Suspension Operations
Official title: Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prolapse
Cuff
Keywords: sacrocolpopexy
Lateral Suspension
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. The investigators will form study groups of patients who underwent these two operations.

Brief summary: Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Detailed description: Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Eligibility criteria: Inclusion Criteria:

* Patients who had previously undergone hysterectomy for benign causes
* Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
* And for this, patients scheduled for operation

Exclusion Criteria:

* Patients with chronic diseases or medications that interfere with the operation
* Patients with oncology operated for malignant cause
* Non-localized patients with vaginal cuff prolapse

Primary outcomes:
measure: recurrence
timeFrame: 1 years
measure: complications
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT02732093: Does Stellate Ganglion Block Decrease Stress Response of Intubation?
Official title: Does Stellate Ganglion Block Decrease Stress Response of Intubation?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intubation
Stellate Ganglion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study investigators will evaluate the effect of stellate ganglion block on stress response of intubation in comparison to traditional antistress measures in adult patients

Detailed description: Both groups will have the same general anesthesia procedure, patients in stellate block group will receive lidocaine in the stellate block will in control group patients will receive Na.Cl as placebo. primary outcome will be stress response to subsequent endotracheal intubation measure by changes in heart rate

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* General anesthesia with endotracheal intubation
* ASA I/II

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to local anesthetics
* Coagulopathy
* Infection at site of injection
* Patient refusal

Primary outcomes:
measure: heart rate
timeFrame: 5 minutes
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospitals
Study officials:
affiliation: Assiut University
name: abdelraheem Elawamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03501693: Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a reader study utilizing retrospectively collected breast images acquired under Fujifilm protocol FMSU2013-004A.

Brief summary: The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.

Detailed description: This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.

Eligibility criteria: Inclusion Criteria:

* •Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

* •Female subjects that did not have known clinical status in FMSU2013-004A

Primary outcomes:
measure: Compare Per Subject AUC: DBT Plus S-View Versus FFDM
timeFrame: 4 weeks
Secondary outcomes:
measure: Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM
timeFrame: 4 weeks
measure: Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases
timeFrame: 4 weeks
measure: Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM
timeFrame: Four weeks
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: International HealthCare, LLC
state: Connecticut
Study officials:
affiliation: Fujifilm Medical Systems USA, Inc.
name: Robert M Uzenoff
role: STUDY_DIRECTOR
References:
Clinical trial NCT04753593: Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Official title: Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoblast
Vascular Calcification
Keywords: osteoblast
Vascular Calcification
vascular smooth muscle cell
Cardiac valve calcification
Valvular interstitial cell
bone tissue
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aortic wall and aortic valve discarded specimens will come from the Cardiac Surgery department of Amiens Picardie CHU. The bone and peri-bone discarded specimens will come from the orthopedic surgery services of the CHU Amiens-Picardie.

The collection of samples and their use is part of various projects carried out by research project leaders supported by the laboratory MP3CV (CURS, site CHU sud, Amiens). No genomic analysis is planned for these samples. None clinical data is associated with the interpretation of data collected through the work that will be carried out from these human tissue samples. There are no collections per se, the samples collected are pseudonymized.

Brief summary: Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery in the Cardiac Surgery and Orthopedic Surgery departments of the CHU Amiens-Picardie
* patients who will be beforehand informed
* patients who will not be opposed to this study.

Exclusion Criteria:

* HIV and hepatitis positive patients

Primary outcomes:
measure: Success in establishment of Cell Culture Systems from discarded surgery specimens
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01642693: Histological Change of The Dentinal-Pulp Complex and Root Resorption
Official title: Histological Changes of The Dentinal-Pulp Complex and Root Resorption in Maxillary Premolars With Intrusive Orthodontic Movements Under a Low Power Laser Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Laser
Intrusion
Histology
Resorption
Keywords: root resorption
low-power laser
orthodontic tooth movement
pulp changes
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 34
Sex: ALL
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.

Detailed description: Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. The objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.

Eligibility criteria: Inclusion Criteria:

* Patients with first premolar extraction indicated
* Patients with no sistemic diseases
* Healthy premolars with completed root and no trauma or restoration

Exclusion Criteria:

* Sistemics diseased
* Restoration, trauma in first premolars
* root uncompleted

Primary outcomes:
measure: Teeth with intrusive movement and low power laser
timeFrame: 12 weeks
Secondary outcomes:
measure: Teeth with intrusive movements with no laser exposition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Paula Villa M
state: Antioquia
Study officials:
References:
Clinical trial NCT05771493: The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain
Official title: The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Weight,
Body mass index
Pelvic index
Waist circumference
Lead sponsor: AZ Nikolaas
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 272 patients; 51.8% male, 3.7% underweight; 28.7 % normal weight; 34.2% overweight and 33.5% obees. 50.4% has high WC. Mean PI 57.78

Brief summary: This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity

Detailed description: Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed.

All included patients had undergone a full spine X-ray allowing to calculate the pelvic index (PI). Weight status was described in 4 categories, in-line with the WHO definitions; Underweight (boddy mass index (BMI)) \< 18.5 kg/m²; normal weight BMI 18.5 - 24.9 kg/m² , overweight BMI 25 - 29.9 kg/m², and obesity BMI ≥ 30 kg/m². To identify people with increased BMI-values and central (abdominal) fat distribution, we used the waist circumference (WC). The cut-off points of waist measurement that are used are 102 cm and 88 cm for men and women respectively. A high sacral slope (SS) means a greater the lumbar curvature, which results in a dynamic back. Due to the correlation between SS and PI, people with high PI values generally have higher values of SS. Therefore types 1 and 2 have a low-grade PI and types 3 and 4 have a high-grade PI Analysis of 272 patient records, shows that the mean PI is significantly different in the group with a low WC compared with the group with a high WC. BMI and WC show a significant correlation with PI

Eligibility criteria: Inclusion Criteria:

* presenting with non-specific low back pain
* having undergone full spine X-ray during the diagnostic proces

Exclusion Criteria:

* patients with missing data
* double entry of patients

Primary outcomes:
measure: Spinopelvic parameters and correlation with BMI and WC
timeFrame: January 1st 2020 - December 23, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: Vitaz
Study officials:
References:
Clinical trial NCT01006993: Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator
Official title: Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemic Stroke
Lead sponsor: CoAxia
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke
* NIHSS between 5-22
* Persistent clinical deficits following administration of rt-PA

Exclusion Criteria:

* Planned thrombectomy
* Aortic pathology
* Severe heart disease
* Other conditions the doctor will assess

Primary outcomes:
measure: An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
timeFrame: Baseline to 30 days post-treatment
Secondary outcomes:
measure: Potential patient benefit will be assessed through collection of neurological indices.
timeFrame: Baseline through 90 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Erlangen
country: Germany
facility: University of Erlangen
Study officials:
affiliation: Various
name: FASTFlo Steering Committee
role: STUDY_DIRECTOR
References:
citation: Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.
Clinical trial NCT03350893: Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
Official title: Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Problems
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Chia Nan University of Pharmacy and Science
First posted: 2017-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel, Open Label Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus plantarum cream on skin health.

Detailed description: To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between the ages of 20-60.

Exclusion Criteria:

* Subjects with photosensitivity (Sun allergy).
* Subjects are undergoing medical therapy for skin diseases.
* Subjects with severe hyperpigmentation.
* Subjects with diabetes.
* Subjects with cosmetics allergy.
* Subjects who have recently participated laser therapies or other treatments are not suitable for sun.

Primary outcomes:
measure: Skin Diagnosis
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: Skin Moisture
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Skin Color
timeFrame: Baseline, 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy and Science
Study officials:
affiliation: Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.
name: Ching-Gong Lin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01629693: Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
Official title: Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: contact lenses
myopia
astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Must sign written informed consent document.
* Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
* Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
* Current contact lens prescription within the available parameters of both study products.
* Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
* Willing and able to follow instructions, study procedures and maintain the appointment schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
* A history of ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotics use within 7 days of enrollment.
* Topical ocular or systemic corticosteroids use within 14 days of enrollment.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30
timeFrame: Baseline, Day 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, Ph.D.
role: STUDY_DIRECTOR
References: