louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01680731: 3D Ultrasound in Women With Vacuum or Forceps Deliveries
Official title: 3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Injury
Urinary Incontinence
Stool Incontinence
Keywords: Pelvic floor injury
Levator ani muscle
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty primiparous subjects with a history of a singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery with 10 subjects in each group.

Brief summary: The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.


Eligibility criteria: Inclusion Criteria:

* Females age \>18 and \<45.
* Primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery.
* Birth weight \>2500g and \<4500g.
* Delivery should have occurred more than one year ago, but less than five years ago.

Pregestational BMI \<35kg40kg/m2.

Exclusion Criteria:

* Presence of interim delivery.
* Presence of both vacuum and forceps use during delivery.
* Presence of pregestational or A2 gestational diabetes mellitus.
* Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).

Primary outcomes:
measure: Levator ani injury on 3D ultrasound
timeFrame: 1-5 years after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Tulin Ozcan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04348331: Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study
Official title: Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 27
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.


Eligibility criteria: Inclusion Criteria:

* Patients with pain related to temporomandibular joint.
* Patients with limited mouth opening.

Exclusion Criteria:

* Patients with pain related to temporomandibular joint for less than one month duration.
* Patients with limited mouth opening for less than one month duration.
* Patients with history of TMJ surgical intervention.
* Patients with history of TMJ arthrocentesis.

Primary outcomes:
measure: Identification of temporomandibular joint effusion.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Delineation of temporomandibular joint disc position.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nouran Nabil Marzaban
Study officials:
affiliation: Cairo University
name: Mohamed K Zayet
role: STUDY_DIRECTOR
References:
Clinical trial NCT04479631: Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
Official title: A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-196 Administered Intravenously to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19 phase I
monoclonal antibody
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: TSB Therapeutics (Beijing) CO.LTD
First posted: 2020-07-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study in which healthy adult volunteers will receive BRII-196 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 to 49 years of age inclusive;
* Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);
* Male or female;

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
* A history of significant hypersensitivity, intolerance, or allergy to any drug compound;
* History of alcohol or other substance abuse;

Primary outcomes:
measure: Incidence of adverse events (AEs) by CTCAE v5.0
timeFrame: up to 24 weeks
measure: Proportion of subjects with SAEs
timeFrame: up to 24 weeks
measure: Proportion of subjects with infusion-related reactions
timeFrame: up to 24 weeks
measure: Proportion of subjects with hypersensitivity reactions
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Serum Concentration of BRII-196
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site
state: Beijing
Study officials:
affiliation: TSB Therapeutics (Beijing) CO.LTD
name: Yao Zhang
role: STUDY_DIRECTOR
References:
citation: Hao X, Zhang Z, Ma J, Cheng L, Ji Y, Liu Y, Zhao D, Zhang W, Li C, Yan L, Margolis D, Zhu Q, Zhang Y, Zhang F. Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults. Front Pharmacol. 2022 Sep 6;13:983505. doi: 10.3389/fphar.2022.983505. eCollection 2022.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Clinical trial NCT04170231: Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses
Official title: Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Bleeding
Keywords: Critically Ill Children
19-407
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 93
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects admitted to the pediatric ICU at MSKCC will be included in this observational study.

Brief summary: "Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses ," will be a prospective observational cohort study looking at the epidemiology of bleeding in the pediatric ICU population at MSK.


Eligibility criteria: Inclusion Criteria:

* All children (≥28 days old through 18 years of age) with an oncologic diagnosis admitted to the PICU at Memorial Sloan Kettering Cancer Center
* An oncologic diagnosis will include those with a cancer diagnosis or those being treated at MSK for blood disorders, immunodeficiencies and complications of transplant.

Exclusion Criteria:

* Preterm infants (\<44 weeks gestation at age of enrollment) as in these patients most bleeding etiologies are specific to the neonatal period and the bleeding assessment tool is not calibrated for this population
* Known limitation of care at enrollment (standing Do Not Resuscitate order), as the interventions and clinical outcome would be biased
* Pre-existing bleeding disorders

Primary outcomes:
measure: the incidence of severity of bleeding
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marianne Nellis, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06506331: Impact of Preoperative VFA on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy
Official title: Impact of Preoperative Visceral Fat Area on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy: A Pooled Analysis From Two Randomized Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
intraoperative adverse events
complications
visceral fat area
laparoscopic surgery
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 490
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A post hoc analysis was performed using data from two previous prospective studies (\[NCT02327481\] and \[NCT01609309\]).

Brief summary: Preoperative visceral fat area (VFA) is associated with an increased incidence of postoperative complications in gastric cancer (GC). However, the relationship between VFA and intraoperative adverse events (iAEs) remains unclear. Therefore, this study aimed to evaluate the impact of preoperative VFA on iAEs in patients undergoing laparoscopic radical gastrectomy for GC, using data from two prospective trials. Simultaneously, a predictive model for iAEs was constructed to provide a basis for the early identification of high-risk populations and the implementation of personalized perioperative management measures.

Detailed description: A post hoc analysis was performed using data from two previous prospective studies (\[NCT02327481\] and \[NCT01609309\]). The patients were divided into high- and low-VFA groups. All iAEs were reviewed from the surgical videos and graded using ClassIntra. Logistic regression analyses were used for the construction of nomograms as predictive models.

Eligibility criteria: Inclusion Criteria:

This study comprised two prospective trials conducted at Fujian Medical University Union Hospital (FMUUH): the FUGES-001 study (ClinicalTrials.gov, NCT02327481) and a subset of the CLASS-01 multicenter study (ClinicalTrials.gov, NCT01609309)

Exclusion Criteria:

1. open surgery;
2. non-adenocarcinoma gastric cancers
3. Palliative surgery
4. Exploratory operation
5. CT data missing

Primary outcomes:
measure: intraoperative adverse events(iAEs)
timeFrame: During surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385031: Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients
Official title: Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Dose-guided radiation therapy
CBCT
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Whole breast irradiation (N=10)
2. Simultaneous integrated boost (N=10)
3. Patients with seroma at start radiation treatment (N=10)

Brief summary: In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Detailed description: During radiotherapy, changes in patient anatomy or positioning can result into differences in dose deposition, which is the main factor influencing tumor control or side-effects. Dose-guided radiation therapy is the systematic evaluation of the dose delivery during treatment for an individual patient with the aim to adapt the treatment if needed. Recalculation of the dose during treatment can be performed using the imaging information during treatment. In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients
* Planned for external beam radiation treatment.
* Whole breast irradiation or Simultaneous integrated boost

Primary outcomes:
measure: Validation of quantitative action levels
timeFrame: 3-4 weeks (time between 1st and last fraction of radiotherapy)
Secondary outcomes:
measure: Automatic re-delineation
timeFrame: 3-4 weeks (time between 1st and last fraction or radiotherapy)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology
Study officials:
affiliation: Radiation Oncologist
name: Karolien Verhoeven, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zegers CML, Baeza JA, van Elmpt W, Murrer LHP, Verhoeven K, Boersma L, Verhaegen F, Nijsten SMJJG. Three-dimensional dose evaluation in breast cancer patients to define decision criteria for adaptive radiotherapy. Acta Oncol. 2017 Nov;56(11):1487-1494. doi: 10.1080/0284186X.2017.1349334. Epub 2017 Aug 29.
Clinical trial NCT04657731: Sociodemographic Factors and Occupational Balance
Official title: Do Sociodemographic Factors Affect Occupational Balance?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Balance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals aged 19-70

Brief summary: Occupational balance is a concept related to health and well-being. Therefore, determining the factors affecting this concept is important for health promotion interventions. There is no study in the literature on the relationship between socio-demographic factors and occupational balance. The results of this study are thought to provide new information to the literature.

Detailed description: Occupational balance is about the perception of having the 'right mix' of activities in life. This balance is analyzed according to types of activity such as self-care, productivity and leisure time, as well as different dimensions such as the physical, mental and social dimensions required to engage in activities. Occupational balance is a concept related to health and well-being. Therefore, determining the factors affecting this concept is important for health promotion interventions. There is no study in the literature on the relationship between socio-demographic factors and occupational balance. The results of this study are thought to provide new information to the literature.

Eligibility criteria: Inclusion Criteria:

Being between the ages of 19-70 Agree to participate in the study

-

Exclusion Criteria:

\<19 years of age, \>70 years of age

Primary outcomes:
measure: Occupational Balance Questionnaire Balance Questionnaire (OBQ11-T)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Özgü İnal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06300931: KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention
Official title: Knowledge, Attitudes and Professional Behavior Towards Use of Silver Diamine Fluoride Among Dental Interns Before Versus After Educational Intervention.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SDF
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 638
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Interns who graduated dental school and are currently enrolled in the pediatric dental department, Faculty of Dentistry, Cairo University

Brief summary: This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention.

Detailed description: The questionnaires will be distributed and filled out under the supervision of the primary investigator.

Each intern will be allowed to fill out the questionnaire. An educational lecture about SDF will follow. The questionnaires will be distributed and filled under the supervision of the primary investigator again.

Eligibility criteria: Inclusion Criteria:

Dental Interns who are enrolled in the pediatric dental department, Faculty of Dentistry, Cairo University who are willing to participate.

Exclusion Criteria:

Dental Interns who are enrolled in the pediatric dental department , Faculty of Dentistry, Cairo University who are unwilling to participate.

Primary outcomes:
measure: Assessment of knowledge levels and attitude regarding SDF use before educational intervention
timeFrame: 2 month
Secondary outcomes:
measure: Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF.
timeFrame: 2 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05779631: Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
Official title: Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: mpMRI + same-day biopsy
TURBT
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Primary purpose: DIAGNOSTIC

Brief summary: A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Patients (18+ years of age) with clinically suspected MIBC, without lymph node or distant metastases, written informed consent

Exclusion Criteria:

* Unable or unwilling to undergo mpMRI
* Unfit for TURBT
* Unfit for definitive treatment with curative intent
* A history of cancer, including bladder cancer, except non-melanoma skin cancer or prostate cancer on active surveillance

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Time to definitive treatment
timeFrame: 2 years
measure: Health-related quality of life
timeFrame: 2 years
measure: Hospital-related healthcare costs
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek - Netherlands Cancer Institute
city: Arnhem
country: Netherlands
facility: Rijnstate ziekenhuis
city: Boxmeer
country: Netherlands
facility: Maasziekenhuis Pantein
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Uden
country: Netherlands
facility: Bernhoven ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Venlo
country: Netherlands
facility: VieCuri medisch centrum
Study officials:
affiliation: Radboud University Medical Center
name: A. G. van der Heijden, Dr.
role: PRINCIPAL_INVESTIGATOR
References: