louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04572880: Evaluation of Minimal Invasive Glaucoma Surgery
Official title: Evaluation of Minimal Invasive Glaucoma Surgery: Trabeculectomy vs. XEN ® vs. Preserflo ®. Randomized Clinial Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: MIGS
XEN®
Trabeculectomy
Preserflo®
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 150
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: Glaucoma is a neurodegenerative disease with an accelerated and progressiv retinal ganglion cell loss and concomitant visual field defects. Glaucoma can be treated with eye drops, laser therapy or surgery. Various surgical approaches to lower intraocular pressure are available, amongst which trabeculectomy is the gold standard. Recently minimal invasive glaucoma surgery has been introduced and has become a good alternative to trabeculectomy. Randomized clinical trials investigating the postoperative outcomes of various types of glaucoma surgery are limited.

Detailed description: 150 Patients will be randomized to one of the 3 surgeries. Trabeculectomy Preserflo® or Xen® will be done according to a standard protocol Data will be collected for 5 years after surgery, Visual Acuity, Applanation Tonometry, Slit lamp Biomicroscopy, Endothelial cell cound, visual fields, optical coherence tomography of the optic disc, retina and anterior segment, impression cytology and life quality will be done on day of enrollment and during followup. Mean Intraocular pressure and number of glaucoma medications, Endothelial cell loss, visual acuity, visual fields and assessment of life quality will be assessed during the post-operative follow-ups at one week, one month, 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Patiens with glaucoma in which surgery is indicated to reach target intraocular pressure
* Subjects not anticipated to require any further surgery in the next 12 months

Exclusion Criteria:

* Patients who do not want to make follow-ups at the department
* angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, Axenfeld-Rieger syndrom.
* Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
* Any major ocular inflammation up to 30 days prior to surgery
* Conjunctival scarring
* Allergy to any drugs required for the protocol

Primary outcomes:
measure: Mean intraocular pressure
timeFrame: up to 5 years post surgery
Secondary outcomes:
measure: Number of medications
timeFrame: up to 5 years post surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
Clinical trial NCT05853380: A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Official title: A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Sign Evaluation
Lead sponsor: Mindset Medical
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 85
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit subjects from clinics and hospitals and the general public. Enrollment of 85 subjects with an age range of 22-85 years of age with a wide range of skin tone categorization per the Fitzpatrick Scale ranging from 1-6.

Brief summary: Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).


Eligibility criteria: Inclusion Criteria:

* Subjects 22 -85 years of age
* Subjects willing to sign the Informed Consent Form and comply with the protocol

Exclusion Criteria

* Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
* Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
* Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
* Condition that does not allow the subject to remain still for 60 seconds at a time
* Subjects with cardiac arrhythmia
* Any known medical condition which may result in an inaccurate measurement using the reference device
* Subjects with the inability to complete an ECG.

Primary outcomes:
measure: Pulse Rate non-inferiority
timeFrame: Baseline only, single visit
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: La Mesa
country: United States
facility: Velocity Clinical Research
state: California
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Columbia
country: United States
facility: Velocity Clinical Research
state: South Carolina
city: Cedar Park
country: United States
facility: Velocity Clinical Research
state: Texas
Study officials:
affiliation: Mindset Medical
name: Dan Lubelski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05049980: Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester
Official title: Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss, Early
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.

The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital


Eligibility criteria: Inclusion Criteria:

* Any adult patient presenting to the gynecological emergency department of the Paule de Viguier Hospital in Toulouse for whom a diagnosis of an arrested pregnancy in the first trimester is made
* Whose cranio-caudal length of the embryo measured by ultrasound is less than 25 mm or having a clear egg
* Having agreed to the study (written or verbal) after clear and fair information
* Who understands and reads French

Exclusion Criteria:

* Medical contraindication to treatment with Mifégyne® or MisoOne®
* Hemodynamically unstable patient requiring urgent surgical treatment.
* Protected adult patient (guardianship, curatorship, safeguard of justice)

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Inclusion day (day 0)
measure: Patient satisfaction
timeFrame: Inclusion day (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Mickael ALLOUCHE
Study officials:
affiliation: CHU Toulouse
name: Mickael ALLOUCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03781180: Validity and Reliability Study of the Motor Accuracy Test
Official title: Randomised, Validity and Reliability Study of the Motor Accuracy Test in Turkey, One of the Sensory Integration and Praxis Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Test-Retest Reliability
Keywords: SIPT
Motor Accuracy
Validity
Reliability
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study sample group consists of 100 children who are studying in a primary school registered to Hatay Provincial Directorate of National Education. The children's ages range between 6 years and 8 years 11 months.

Brief summary: The Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this paper.

Detailed description: The study sample group consists of 100 children who are studying in a primary school registered to Hatay Provincial Directorate of National Education. The children's ages range between 6 years and 8 years 11 months.

Eligibility criteria: Inclusion Criteria:

* not having any physical, psychological or mental disabilities,
* to be aged between 6 years and 8 years and 11 months,
* to have the consent of both the child and the parents.

Exclusion Criteria:

* identified as having any kind of physical, visual or hearing disabilities,
* having mental retardation, or possessing a learning disability.

Primary outcomes:
measure: Motor Accuracy-Revised Test
timeFrame: 2-weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Academic Member
name: Fehime S Akbay, MS
role: STUDY_DIRECTOR
affiliation: Academic Member
name: Ferda Dokuztuğ Üçsular, Professor
role: STUDY_CHAIR
affiliation: Academic Member
name: Tomris Duymaz, Assist prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830192: REM (Risk Of Endometrial Malignancy)
Official title: REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Disease
Keywords: endometrial cancer
score
nomogram
ultrasound
HE4
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 741
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.

Detailed description: Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.

Eligibility criteria: Inclusion Criteria:

1. aged between 45 and 80 years;
2. Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria;
3. informed consent obtained from the patients.

Exclusion Criteria:

1. abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
2. presence of a previous malignancy;
3. presence of concomitant adnexal masses.

Primary outcomes:
measure: REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy.
timeFrame: 2 year
Secondary outcomes:
measure: REM
timeFrame: 2 years
Other outcomes:
measure: REM
timeFrame: 2 years
Locations:
city: Rome
country: Italy
facility: campus bio-medico of Rome
Study officials:
affiliation: Campus Biomedico University of Rome
name: Roberto Angioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05178992: Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
Official title: Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults With Mild Cognitive Impairment, Alzheimer's Disease and Related Dementia in Long Term Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Alzheimer Disease
Keywords: Apathy
Robotics
Virtual Reality
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either Usual Activity Program or Usual Activity Program + Robot Activity within each long term care facility. At each site, the order of the robot type (humanoid or dog) will be randomized. Each participant will participate in two sessions/week for 8 weeks (4 weeks with humanoid robot, 4 weeks with dog robot).
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.


Eligibility criteria: Inclusion Criteria:

* Residing \>3 months in long term care facility
* Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score \<15, AD8\<2, DSRD\<19), or moderate dementia (SAGE \<15, AD8\>1, DSRD 19-36)
* Symptoms of apathy (Score 30+ on AES-C)

Exclusion Criteria:

* Severe cognitive impairment
* Physically unable to participate
* Unable to provide assent
* Uncorrected vision or hearing
* Never spoke English
* Unable to sit comfortably in chair
* Acutely ill, terminally ill or unresponsive
* Unable to be moved to activity location
* Aggressive or combative

Primary outcomes:
measure: Change in Apathy
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Trail Making Test (TMT)
timeFrame: Baseline to Week 8
measure: Change in Animal Fluency Test
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
Clinical trial NCT02330692: Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with MDS in Severance Hospital. All patients are eligible for study occuring from the starting day of the study. Patients are enrolled if the written consent are acquired. Considering the annual incidence rate of the disease, target patient population is 1,000 people during the study period.

Brief summary: Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.


Eligibility criteria: Inclusion Criteria:

* MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.

  * Male and Female over 16 years of age. ③ Written consent of the patient to participate in the cohort ④ Deaths during the study period are waiver of consent

Exclusion Criteria:

① Refusal or trouble understanding the written consent

Primary outcomes:
measure: the number of patients with MDS to examine new prognostic factors
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01423292: Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Colecctomy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2011-08-25
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.


Eligibility criteria: Inclusion Criteria:

* aged 20\~80
* undergoing laparoscopic colectomy

Exclusion Criteria:

* allergic history to local anesthesitcs
* tolerance to opioid
* cannot use IV-PCA
* previous abdominal surgery
* intestinal obstruction
* emergency

Primary outcomes:
measure: pain score during cough
timeFrame: 24hr after TAP block
Secondary outcomes:
measure: pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality
timeFrame: 24hr, 48hr, 72hr after TAP block
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06740292: InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.
Official title: InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Mandibular Fracture
Keywords: anterior mandibular fracture
symphyseal fracture
para-symphyseal fracture
InterFlex plate
functionally stabilized fixation
miniplate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 18
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 study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.

Detailed description: A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.

Eligibility criteria: Inclusion Criteria:

* patients with recent anterior mandibular fracture located between the mental foramina.
* adults without gender predilection who agreed to follow-up,
* fractures requiring open reduction and internal fixation, and
* those medically fit for general anesthesia were included

Exclusion Criteria:

* medically compromised patients,
* fractures with infection,
* pathological or old fractures,
* completely edentulous patients,
* comminuted fractures

Primary outcomes:
measure: Radiographic evaluation for the assessment of mean bone density at the fracture line
timeFrame: 3 months
Secondary outcomes:
measure: Clinical evaluation for pain
timeFrame: six weeks
Other outcomes:
measure: Clinical evaluation for Intra-fragmentary mobility
timeFrame: six weeks
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT01667692: Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Official title: Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer
Dyspepsia
H-pylori
Keywords: H-pylori
eradication
azithromycin
clarithromycin
Lead sponsor: Shahid Sadoughi University of Medical Sciences and Health Services
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 comparison between two regimens containing clarithromycinand azithromycin.

Detailed description: Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not available.

HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it is not available in underdevelopment countries.

There are different articles about replacement clarithromycin with azithromycin as a method of eradication of HP that is decreases length of therapy and increases, effectiveness of drugs and decreases resistance of drugs.

The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.

Eligibility criteria: Inclusion Criteria:

* patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy

Exclusion Criteria:

* patients who got H-pylori eradication treatment previously
* patients who used study drugs during 3months before study

Primary outcomes:
measure: H-pylori cinfirmation
timeFrame: 1-3 months before study
Secondary outcomes:
measure: h-pylori eradication confirmation
timeFrame: two months after completion of 14 days standard treatment
measure: side effect of study srugs
timeFrame: during 14 days standard treatment
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Behnam Baghianimoghadam
Study officials:
References: