louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02663635: Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
Official title: Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Needle Stick
Lead sponsor: Nemera La Verpilliere
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges

Detailed description: This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.

Eligibility criteria: Inclusion Criteria:

The Evaluator must be:

* Minimum of age 18
* Able to understand and provide signed consent for the study
* Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires
* Have no concerns about the ability to perform the simulated injections
* With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)

Exclusion Criteria:

* If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.

Primary outcomes:
measure: The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange
timeFrame: At time of testing, day 1
Secondary outcomes:
measure: Ease of Use
timeFrame: At time of testing, day 1
measure: Evaluator assessment of device handling
timeFrame: At time of testing, day 1
measure: Evaluator assessment of instructions
timeFrame: At time of testing, day 1
measure: Evaluator assessment of improvement of device over predecessor device
timeFrame: At time of testing, day 1
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: NAMSA
state: Minnesota
Study officials:
affiliation: NAMSA
name: Timothy Pratt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062435: Corneal Uptake of Riboflavin Eye Drops
Official title: Corneal Uptake of Riboflavin Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to optimise the corneal cross-linking standard protocol in terms of a more economical use of the resource "medical personnel" and in terms of increased patient participation. If it can be shown that the riboflavin necessary for corneal cross-linking does not necessarily have to be applied directly on the cornea (as currently performed by the nurses), but can also be applied in the inferior fornix (as it would be performed by patients in the context of self-application), then it would be conceivable to transfer this task from medical staff to the patients.

Detailed description: This national single-centre, experimental, randomized and controlled trial will comprise two parallel arms. The intervention to be studied will be an alternative application of riboflavin drops in the inferior fornix. As comparator serves a conventional riboflavin drop application directly on the center of the cornea. Our research hypothesis is that the application of riboflavin drops in the inferior fornix is not inferior to the corneal application with respect to the resulting riboflavin concentrations in the anterior chamber; which represents a sufficient corneal impregnation with riboflavin. This study is randomized but not blinded. Recruitment is anticipated to start in September 2019 and is scheduled to last 1-2 months. We will enroll 12 patients in each trial arm.

Eligibility criteria: Inclusion Criteria:

* Healthy clinical staff members of the Dept. of Ophthalmology at the Lucerne Cantonal Hospital will be evaluated for study inclusion.
* Signed written informed consent form

Exclusion Criteria:

* Aged \< 18 years
* Any ocular or systemic diseases with ocular side effects
* Medication with potential ocular side effects
* Epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration

Primary outcomes:
measure: Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)
timeFrame: Three hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Dept. of Ophthalmology, Lucerne Cantonal Hospital
Study officials:
affiliation: Dept. of Ophthalmology, Lucerne Cantonal Hospital
name: Katja Iselin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774835: Assisted Partner Services and HIVST in Western Kenya
Official title: Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: HIV self-testing
Assisted partner services
Acceptability
Implementation Science
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Kenyatta National Hospital
name: University of Nairobi
First posted: 2021-03-01
Enrollment: 4941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: SCREENING

Brief summary: This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.


Eligibility criteria: Inclusion Criteria:

Aim 1:

* Men and women
* Tests HIV positive and is not in care or on treatment
* ≥18 years old
* Willing and able to provide informed consent
* Able to provide locator information for sexual partners

Aim 2:

* ≥18 years old
* Willing and able to provide informed consent

Exclusion Criteria:

Aim 1:

* Pregnancy
* Reports intimate partner violence during last month
* \<18 years old

Aim 2:

• \<18 years old

Primary outcomes:
measure: Number of participants testing for the first time
timeFrame: 1 year
measure: Number of newly diagnosed HIV-infected or known positive and not in care
timeFrame: 1 year
measure: Linking a new positive or known positive not in care to a treatment center
timeFrame: 1 year
measure: Initiating ART, or re-initiating ART if previously lost to follow-up
timeFrame: 1 year
Secondary outcomes:
measure: Difficulty of using the HIVST kit
timeFrame: 1 year
measure: Difficulty of interpreting the HIVST results
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Carey Farquhar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037135: Dexmedetomidine Infusion During Laparoscopic Adrenalectomy
Official title: The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pheochromocytoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.


Eligibility criteria: Inclusion Criteria:

1. ages of 20 and 70
2. American Society of Anesthesiologists(ASA) physical status classification I to III,
3. planned laparoscopic adrenalectomy for pheochromocytoma.

Exclusion Criteria:

1. emergency operation,
2. re-operation,
3. combined surgery with other departments,
4. body mass index (BMI) \>32 kg/m2,
5. history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
6. uncontrolled hypertension (diastolic blood pressure \>110mmHg)
7. bradycardia (heart rate \< 40 beats per minute),
8. history of heart failure, hepatic and/or renal failure,
9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.

Primary outcomes:
measure: Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))
timeFrame: during operation
measure: Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)
timeFrame: during operation
measure: Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)
timeFrame: during operation
measure: Intraoperative hemodynamic stability (maximum HR during surgery)
timeFrame: during operation
measure: Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)
timeFrame: during operation
measure: Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)
timeFrame: during operation
Secondary outcomes:
measure: levels of catecholamines
timeFrame: immediately after anesthesia induction
measure: levels of catecholamines
timeFrame: immediately after removal of the pheochromocytoma
measure: levels of catecholamines
timeFrame: immediately after the completion of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Young Jun Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06693635: Comparative Evaluation of Implant Planning Software
Official title: Evaluating the Impact of Artificial Intelligence in Implant Planning Software: A Case Study Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Jaw
Edentulous Alveolar Ridge
Edentulous Mouth
Partial-edentulism
Keywords: Artificial Intelligence in Implantology
AI
Implant planning
AI software
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients requiring implant rehabilitation with digital planning

Brief summary: Artificial intelligence (AI) is increasingly being integrated into dental implant planning, revolutionizing the way clinicians approach treatment. AI-driven software can enhance the accuracy of implant placement by analyzing complex data sets, including bone density, anatomical structures, and patient-specific factors. This technology enables the creation of precise 3D models and surgical guides, facilitating more predictable and personalized treatment outcomes. Additionally, AI algorithms can automate tasks such as segmentation, matching digital impressions with CBCT scans, and even suggesting optimal implant positions. The integration of AI in implant planning not only improves clinical efficiency but also contributes to better patient outcomes by reducing surgical risks and enhancing the overall success of implant procedures.


Eligibility criteria: Inclusion Criteria:

* CBCT of Patient who needs Implant rehabilitations

Exclusion Criteria:

* Patient not suitable for implant rehabilitation

Primary outcomes:
measure: Segmentation of Bones
timeFrame: 1 day
measure: Recognition of Neural structure
timeFrame: 1 day
measure: Segmentation of teeth
timeFrame: 1 day
measure: Bone density
timeFrame: 1 day
measure: Time Workflow
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari Aldo Moro
Study officials:
affiliation: University of Bari Aldo Moro
name: Giuseppe D'Albis, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bari Aldo Moro
name: Massimo Corsalini, Prof
role: STUDY_DIRECTOR
affiliation: University of Bari Aldo Moro
name: Saverio Capodiferro, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05288335: Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Official title: Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Detailed description: Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.

Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Eligibility criteria: Inclusion Criteria:

1. 6-13 years old;
2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
3. Monocular best corrected visual acuity (VA) of 1.0 or better;
4. Acceptance of random group allocation and the masked study design
5. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion Criteria:

1. Strabismus.
2. Ocular and systemic abnormalities.
3. Prior experience of myopia control.
4. Only one eye meets the inclusion criteria.

Primary outcomes:
measure: Changes in ocular axial length in a year
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Changes in cycloplegic objective spherical equivalent in a year
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Xiaoqin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
Clinical trial NCT01120535: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Keywords: Vena Cava
Vena Cava Filter
Pulmonary Embolism
Venous Thromboembolism
Risk of Pulmonary Embolism
Lead sponsor: Crux Biomedical
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism.
* Patient must provide informed consent At least one of the following conditions -
* Proven PE
* Recurrent PE despite adequate
* Contraindication to anticoagulation
* Inability to achieve/maintain therapeutic anticoagulation
* Iliocaval DVT
* Large, free-floating proximal DVT
* Massive PE treated with thrombolysis/thrombectomy
* Chronic PE treated with thrombectomy
* Protection during thrombolysis for iliocaval DVT
* PE with limited cardiopulmonary reserve
* Poor compliance with anticoagulation medication
* High risk of injury worsening on anticoagulation
* Multi-trauma patient with high risk of PE
* Surgical patients at high risk of PE
* Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions:

  * Renal vein thrombosis
  * IVC thrombosis extending to the renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Vena cava diameter of 17-28mm
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude same insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits

Primary outcomes:
measure: Clinical Success
timeFrame: 6 Months
Secondary outcomes:
measure: Rates of complications related to vena cava filter use.
timeFrame: 6 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane Womens Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References:
Clinical trial NCT02285335: Effects of GINST on Human Semen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the effect of GINST on human semen. The study is a pilot study, designed as open-label, prospective randomized clinical trial using GINST either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng). Expected participants are to be male partners of female patients who visit infertility clinic at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone. Quality of life, sexual performance before and after taking GINST will be evaluated using questionaires.


Eligibility criteria: Inclusion Criteria:

1. partner of female patient who visit infertility clinic with chief complaint of infertility.
2. ≥0.5x106 of total motile sperm count on screening semen analysis.

Exclusion Criteria:

1. Those who have chronic, systemic disease or endocrinologic disorder.
2. Patients with hypertension (systolic blood pressure ≥ 140mmHg, diastolic blood pressure ≥ 90mmHg)
3. Patients who have undergone chemotherapy due to malignancy
4. Patient who has history of taking testosterone or anti androgen agents within 1 month.
5. Patient who has retrieved sperm surgically

Primary outcomes:
measure: Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)
timeFrame: 12 week
Secondary outcomes:
measure: serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)
timeFrame: 12 week
measure: Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale)
timeFrame: 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT04647435: Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Official title: National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postsurgical Pain
Third Molar Extraction
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.


Eligibility criteria: Main Inclusion Criteria:

* Males and Females aged 18 to 40 years;
* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants who require extraction of impacted mandibular third molar.

Main Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Previous history of renal failure from moderate to severe;
* Women who are pregnant, lactating, or positive for β - hCG urine test.

Primary outcomes:
measure: At least 50% of maximum pain relief score (TOTPARmax)
timeFrame: Change from Baseline to 6 hours
Secondary outcomes:
measure: Adverse events incidence and classification
timeFrame: During treatment
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
state: São Paulo
Study officials:
References: