louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02326701: RV Function Evaluation Assessed by Strain and Validated by MRI
Official title: RV Function by Strain and MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Ventricular Function
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 200
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 performing MRI for any indication

Brief summary: Echocardiographic assessment of right ventricular function is an important diagnostic tool, and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a new technique has been developed and used for evaluating both the left and the right ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on detecting speckles in the myocardial tissue and using them as acoustic markers. The movement of these speckles represents the movement of the tissue, and allows us to evaluate its function, contraction and relaxation, this by calculating the strain rate, which is the speed of the speckles, and the strain, which is the distance between them.

In the last few years this technique has been used to evaluate the systolic function of the right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV strain and strain rate values.

In this study the investigators aim to validate two dimensional (2D) speckle tracking measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each patient performing cardiac MRI for any indication will perform an echocardiography examination in addition, and strain analysis performed on the cardiac MRI will be compared with two dimensional speckle tracking analysis performed on the echocardiography.


Eligibility criteria: Inclusion Criteria:

* Age: More than 18

Exclusion Criteria:

* Age: Children
* Unconcious patients.

Primary outcomes:
measure: Correlation of 2D Echo and Echo strain measurements versus MRI measurements
timeFrame: 1 year
Secondary outcomes:
measure: Rehospitalization
timeFrame: 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00141401: Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.
Official title: An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind study
* Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.

Exclusion Criteria:

* Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.

Primary outcomes:
measure: Safety Efficacy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04894201: Deep Learning to Summarize Findings in Dental Panoramic Radiographs
Official title: Deep Learning to Summarize Findings in Dental Panoramic Radiographs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiography
Digital
Dental Diseases
Dentist-Patient Relations
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with panoramic image exposure and not with exclusion criteria

Brief summary: In this work, the investigators study the application of artificial intelligence systems on dental panoramic images for dental findings. An artificial intelligence system will be learned on an publicly available panoramic image dataset, and test against the investigators' local patient cohort as external test data. The investigators hypothesize the performance would be similar, if not identical to on the public data, and that the investigators' AI system is generalizable.


Eligibility criteria: Exclusion Criteria:

* patients under 20 or with primary teeth
* patients with non-removable metal accessory above neck, such as tongue ring, nose ring etc.
* patients with mandible or maxilla deformation

Primary outcomes:
measure: Area Under Curve for Receiver Operating Characteristics of Clinical Findings
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05615467: A Study of Effect of LY3556050 on Metformin in Healthy Participants
Official title: An Open-Label Study in Healthy Participants to Evaluate the Effect of LY3556050 on Metformin Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how much Metformin gets into the bloodstream and how long the body takes to get rid of it when it is administered orally in combination with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney function. Each enrolled participant will remain in the study for up to 7 weeks including the screening period.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Participants with body weight of at least 50 kilograms (kg) or more and have a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²)
* Have an ECG at screening considered to be within acceptable limits by the investigator
* Male participants who agree to use contraception and female participants of child bearing potential who agree to use contraception and women not of child bearing potential may participate.

Exclusion Criteria:

* Women who are lactating
* Have known allergies or contraindications to LY3556050, metformin, iodine, iohexol, or other contrast agents, related compounds or any components of their formulation, or history of significant atopy
* Have a history, or ECG findings, of clinically significant bradycardia, heart block, tachycardia, sick sinus syndrome/sinoatrial block, first-degree AV block, or second- or third-degree AV block, bundle branch block or other tachy- or brady-arrhythmias; o rhave any other abnormality in the 12-lead ECG that, in the opinion of the investigator, confounds assessment of QT interval or increases the risks associated with participating in the study
* Have active or a history of gastritis or peptic ulcer disease

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin
timeFrame: Predose on day 1 through 13 days postdose
measure: PK: Maximum Observed Drug Concentration (Cmax) of Metformin
timeFrame: Predose on day 1 through 13 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA International
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02660567: Amr's Maneuver and Postpartum Hemorrhage
Official title: The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
PPH
atonic
new maneuver
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Ain Shams University
name: October 6 University
name: National Research Centre, Egypt
First posted: 2016-01-21
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Detailed description: Primary:

Compare the incidence of post partum hemorrhage (PPH\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Secondary:

Comparing:

* The amount of blood loss in each arm of the study
* Hematocrit before and after labor
* Duration from delivery of placenta till discharge from the delivery room

Eligibility criteria: Inclusion Criteria:

* All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included

Exclusion Criteria:

* Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery

Primary outcomes:
measure: the incidence of postpartum hemorrhage
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University Hospitals (Kasr Al-Aini)
Study officials:
affiliation: Egypt National Research Centre Reproductive Health Research Department
name: Osama Azmy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ClinAmygate
name: Emad RH Issak, DM
role: STUDY_DIRECTOR
References:
citation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
citation: Hamdy A, Azmy O, Lotfy R, Attia AA, Elsherbini MM, Al Sawaf A, Soliman MM, Sharaf MF, Kamel A, Abd El-Raouf MN, Salem S, Rasheed MA, Torky H, Issak ER. Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jan;144(1):56-61. doi: 10.1002/ijgo.12687. Epub 2018 Oct 22.
Clinical trial NCT03492567: Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.
Official title: Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
CFTR
CFTR modulators
Monocyte
Osteoclast
Osteoporosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
First posted: 2018-04-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.

Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.

Finally the action of CFTR modulators on these bone cells will be tested.

Detailed description: The aim of the study is to characterize the profile of circulating monocytes as predictive biomarker of osteoclastogenesis in CF related bone disease.

Investigators will evaluate the presence and regulation of CD115 (MCSF receptor) and CD265 (RANK) membrane receptors of circulating monocytes of cystic fibrosis patients.

They will also analyze the impact of the F508del CFTR mutation on the differentiation of monocytes into osteoclasts. We will 1) Quantify the training and functional activity of osteoclasts and, 2) Test in vitro the effects of correctors and potentiators of CFTR on the resorption activity of differentiated osteoclasts.

The study will be explained to patients and they only will have one blood test.

Eligibility criteria: Inclusion Criteria:

* patients with cystic fibrosis
* attending the Paris Cochin adult CF centre
* with at least F508del mutation (homozygote or heterozygote patients)

Exclusion Criteria:

* patients younger than 18
* absence of signed consent
* patients without a F508del mutation

Primary outcomes:
measure: Phenotype of CD14 monocytes/osteoclasts
timeFrame: 1 day
Secondary outcomes:
measure: In vitro test of CFTR modulators
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique HUBERT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797467: Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Official title: Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Chemotherapy Effect
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 366
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: The goal of this clinical trial\] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

1. Both sexes, aged 18-75 years;
2. Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
3. ASA grade \< IV and/or ECOG performance status score ≤ 2 points;
4. Fully understand and voluntarily sign the informed consent form for this study.

Exclusion Criteria:

1. A history of other malignant tumors;
2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
3. Patients allergic to any component in the study;
4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
5. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
7. Patients with a history of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: 3 years after operation.
measure: 5-year disease-free survival
timeFrame: 5 years after operation.
measure: median of disease-free survival
timeFrame: 5 years after operation.
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 3 years after recruited.
measure: 5-year overall survival
timeFrame: 5 years after recruited.
measure: Complications
timeFrame: 5 years after recruited.
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05996367: Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Official title: Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Palliative care
Radiotherapy
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.


Eligibility criteria: Inclusion Criteria:

* Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;
* Age between 18 and 85 years old;
* Performance on the ECOG scale less than or equal to 2.
* Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.

Exclusion Criteria:

* Refusing to sign or inability to understand the consent term;
* Pain less than 2/10 on the numeric pain rating scale;
* Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
* Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;
* Previous cancer and previous oncological treatments;
* Previous autoimmune diseases, even if controlled;
* Current pregnancy.

Primary outcomes:
measure: Retreatment rate at 6 months
timeFrame: 6 months after radiotherapy
Secondary outcomes:
measure: Local control
timeFrame: 6 months and 12 months
measure: Progression-free survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Bone event-free survival
timeFrame: 6 months
measure: Pain relief by the numerical rating pain scale
timeFrame: 1, 3, 6 and 12 months
measure: Pain flair incidence
timeFrame: 1, 3, 6 and 12 months
measure: Quality of life by EORCT QLQ-C30
timeFrame: 1, 6 and 12 months
measure: Quality of life by EORCT QLQ-C30 and MY-24
timeFrame: 1, 6 and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Geovanne P Mauro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01695967: Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
Official title: Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Nasal Obstruction
Keywords: nasal obstruction
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.

Detailed description: To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.

Eligibility criteria: Inclusion Criteria:

* ages 3-16
* obstructive sleep apnea warranting adenotonsillectomy
* history of daytime nasal obstruction and or mouth breathing
* failed medical treatment with either oral anti-histamine or nasal steroid spray.
* turbinate hypertrophy on Physical Exam defined by \>50% obstruction

Exclusion Criteria:

* \<3 or \>16
* unwillingness to comply with study procedures
* congenital head and neck malformations, genetic syndromes, craniofacial anomalies
* no evidence of turbinate hypertrophy or symptoms of nasal obstruction
* pregnancy or breastfeeding
* bleeding disorders
* current therapy with coumadin or Pradaxa

Primary outcomes:
measure: # of participants with improved nasal obstruction score from baseline to 6 months
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Christina Baldassari, MD
role: PRINCIPAL_INVESTIGATOR
References: