louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04721951: An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair
Official title: CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Endovascular Aortic Repair
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with AAA, undergoing EVAR

Brief summary: The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Male, female
* Patients with indication for AAA
* Informed consent achievement

Exclusion Criteria:

* Severe COPD (Chronic Obstructive Pulmonary Disease)
* Known atrium- or ventricular septal defect with right-left-shunt
* Severe renal arteries atherosclerosis
* Ruptured AAA
* Current partecipation in other interventional studies

Primary outcomes:
measure: Technical Success
timeFrame: 30 Days
Secondary outcomes:
measure: Image Quality
timeFrame: 30 Days
measure: Endoleak Detection
timeFrame: 30 Days
measure: CO2 Quantity
timeFrame: 30 Days
measure: Aneurysm Exclusion
timeFrame: 30 Days
measure: Adverse Events
timeFrame: 30 Days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of experimental diagnostic and specialty medicine - Vascular Surgery
Study officials:
affiliation: Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna
name: Mauro Gargiulo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00144651: Study of MRA in Patients With Rheumatoid Arthritis (RA)
Official title: An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.


Eligibility criteria: Inclusion Criteria:

* Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
* Patients confirmed to have shown the safety in the preceding study.

Exclusion Criteria:

* Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
* Patients who received any of the following treatments between the start of preceding study and the registration of this study.

  1. Plasma exchange therapy
  2. Surgical treatment (e.g., operation)

Primary outcomes:
measure: ACR 20% responder rate compared to the pre-treatment in the preceding study
timeFrame: throughout study
measure: Frequency and severity of adverse events and adverse drug reactions
timeFrame: week0,week4,week8,week12,and LOBS
Secondary outcomes:
measure: Time course of DAS28,compared to the pre-treatment in the preceding study
timeFrame: week 0,week 4,week 8,week 12, LOBS
measure: Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
timeFrame: week 0,week 4,week 8,week 12, LOBS
measure: ACR N AUC compared to the pre-treatment in the preceding study
timeFrame: week 0,week 4,week 8,week 12, LOBS
measure: Time course of the ACR core set variables compared to the pre-treatment in the preceding study
timeFrame: week 0,week 4,week 8,week 12, LOBS
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT06956651: 18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations
Official title: 18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Occlusal Caries
Keywords: self adhesive giomer
class I
clinical performance
Beautifil Flow
FIT SA
USPHS Criteria
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 40
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 compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.

Detailed description: There is no available evidence discussing the FIT SA restorative material in the restoration of occlusal lesions. This study aims to provide valuable insights into the clinical performance of this restorative material compared to the gold standard.

Eligibility criteria: Inclusion Criteria:

* Posterior vital tooth with Class I caries.

Exclusion Criteria:

* Teeth with clinical symptoms of pulpitis, such as spontaneous pain.
* Pain or sensitivity to pressure.
* Non-vital teeth.
* Fractured or cracked teeth.
* Endodontically treated teeth.
* Periodontally affected teeth.

Primary outcomes:
measure: Clinical performance
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03368651: The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official title: The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* estimated tumor and tumor thrombosis could be removed en bloc in operation;
* no distant metastasis;
* the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
* sign up consent;

Exclusion Criteria:

* cannot tolerate TAI or surgery;
* distant metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: recurrence-free survival (RFS)
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06171451: Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).
Official title: Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected to be evaluated with 11C-Fe-CIT PET: Over the age of 18 years, with a diagnosis of initial PD or parkinsonism and at the time of the PET study, patients will express their written consent for the anonymous use of the data relating to their 11C-Fe-CIT' examination for scientific purposes.

Brief summary: The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.

Given these premises, the possibility of identifying the disease in the early stages appears fundamental.

For this purpose the following should be considered:

1. an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
2. the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.

Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.

In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with initial PD or parkinsonism;
* signature of informed consent.

Exclusion Criteria:

* patients \< 18 years

Primary outcomes:
measure: PET11C-Fe_CIT method for the staging of patients with Parkinson.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03134651: Preoperative Anxiety at Oocyte Retrieval
Official title: The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Anesthesia Awareness
Anxiety State
Keywords: Anxiety
Oocyte retrieval
Monitoring of brain function
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 131
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group.

Detailed description: Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually accompanied by psychological and behavioral changes and can result in preoperative anxiety. Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on recovery from anesthesia. In addition, the negative effect of anesthetic agents used on fertilization and embryo quality during in vitro fertilization (IVF) has been discussed. However, the impact of any of them on fertilization and embryo quality has not been clearly determined to date. Studies have reported different results regarding the negative effects of anesthetic agents on embryo development and fertilization.

Eligibility criteria: Inclusion Criteria:

* oocyte retrieval under sedation
* 25 and 43 years of age
* American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

* history of psychiatric illness
* secondary infertility can be surgically corrected
* not able to communicate well in the native language
* those women who necessitated general anesthesia

Primary outcomes:
measure: Changes in perioperative Monitoring brain function were measured
timeFrame: Preoperative, intraoperative and postoperative first minute
Secondary outcomes:
measure: pregnancy rate
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Trakya University Medical Faculty
name: Sevtap Hekimoglu Sahin, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01392651: Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
Official title: Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Stress Incontinence
Keywords: Urinary stress incontinence
TVT
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-07-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or TVTS.

Brief summary: Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.


Eligibility criteria: Inclusion Criteria:

* Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago

Exclusion Criteria:

* Women who have not undergone TVT procedure

Primary outcomes:
measure: Prevention of stress incontinence
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of side effects: tape erosion, pain, bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology, Western Galilee Hospital
city: Rishon Lezion
country: Israel
facility: Clinics of Dr Neuman
Study officials:
References:
Clinical trial NCT00545051: A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Official title: A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-17
Enrollment: 140
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* post-menopausal women, 50-85 years of age;
* any inflammatory rheumatoid disease including polymyalgia rheumatica;
* receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

* previous treatment with an iv bisphosphonate at any time;
* previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within last year, or \>3 months of treatment within last 2 years;
* treatment with parathyroid hormone in last 2 years;
* inability to stand or sit in an upright position for at least 60 minutes;
* inability to swallow a tablet whole;
* history of major gastrointestinal disease.

Primary outcomes:
measure: Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
timeFrame: Baseline and Month 6
measure: Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
timeFrame: Baseline and Months 6 and 12
measure: Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
timeFrame: Baseline and Months 1, 6 and 12
measure: Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months
timeFrame: Month 6
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Hyvinkää
country: Finland
city: Hämeenlinna
country: Finland
city: Jyvaeskylae
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Vantaa
country: Finland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03600051: Automated Phonocardiography Analysis in Adults
Official title: Phonokardiographie Bei Erwachsenen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Insufficiency
Aortic Stenosis
Mitral Insufficiency
Mitral Insufficiency and Aortic Stenosis
Tricuspid Regurgitation
Insufficiency, Pulmonary
Insufficiency, Tricuspid
Lead sponsor: CSD Labs GmbH
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly in-patient subjects admitted to the Division of Cardiology, University Hospital Graz, Austria. All patients had known pathological murmurs caused by multiple valve defects, confirmed by gold standard echocardiography. Defects were interpreted by the cardiologist as "low, medium or high" severity. Altogether, 155 valve defects were observed, including insufficiencies of the aortic, mitral, tricuspid, and pulmonary valves; and stenosis of the aortic and mitral valves.

Brief summary: Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists.

Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III).

Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist.

Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.


Eligibility criteria: Inclusion Criteria:

* Adults with a heart defect verified by echocardiography

Primary outcomes:
measure: Sensitivity for pathological heart murmur detection
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Hospital
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Rita Riedlbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01200251: Study of Bimatoprost Gel on Eyelash Growth
Official title: The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Madarosis
Hypotrichosis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.


Eligibility criteria: Inclusion Criteria:

* 18-80 YO females
* madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
* only breast cancer patients

Exclusion Criteria:

* inability to follow up, apply gel
* active eye/eyelid infection or inflammatory process
* cancer not related to breast cancer, healthy patients
* males

Primary outcomes:
measure: eyelash length
timeFrame: 6 months
Secondary outcomes:
measure: eyelash pigment
timeFrame: 6 mos
measure: eyelash thickness
timeFrame: 6 mos
measure: eyelash amount
timeFrame: 6 mos
measure: eyelash side effects
timeFrame: 6 mos
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.