louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04933032: Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
Official title: Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes
Keywords: niche , caesearan section scar defect , isthmocele
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women undergoing a C-section will be asked to pariticpate in the study with follow up cases for 6 months

Brief summary: The primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(CSSD) once the appropriate diagnostic criteria are established the natural history of CSSD could be elucidated through exploration of the prevelance ,risk factors, and associated symptomes of the disease


Eligibility criteria: Inclusion Criteria:

* all women underwent c-section

Exclusion Criteria:

* known uterine anomaly
* prior uterine surgery -prior uterine rupture
* chronic medical disease like diabetes -use of steroid over last year regularly
* obstetrical complications like multifetal pregnancy

Primary outcomes:
measure: prevelance and risk factors of ceasearan section defects
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Abdelraman Fasial
Study officials:
References:
Clinical trial NCT03911232: The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
Official title: The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Intra-Operative Injury
Keywords: intraoperative neural monitoring
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.

Detailed description: An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

Eligibility criteria: Inclusion Criteria:

* patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

Exclusion Criteria:

* Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index \<18.5 or \>35, chronic drug or alcohol abuse

Primary outcomes:
measure: sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium
timeFrame: 1 month each case
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: I-Cheng Lu
Study officials:
References:
Clinical trial NCT04298632: Latino Youth Agricultural Study
Official title: Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pesticide Safety
Keywords: Latino Youth
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-03-06
Enrollment: 118
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.

Detailed description: This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The intervention will be delivered to two different treatment groups: 1) adolescent only, adolescents receive the adapted adolescent version of La Familia Sana program and 2) family enhanced, adolescent and mother both receive the La Familia Sana program. In addition, there will be a control group where adolescent farmworkers will not be exposed to any pesticide safety program. Our project will:

1. Determine if a promotora-based intervention targeting pesticide safety in the workplace is effective in increasing knowledge about safety behaviors among Latino adolescents engaged in farm work.
2. Delineate variation by group among adolescents' knowledge about safety behaviors.
3. Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.

Eligibility criteria: Inclusion Criteria:

* Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage
* Adolescent is between the ages of 12-21
* Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days
* Adolescent has a parent living with them

Exclusion Criteria:

* Refusal of youth to provide assent or parent to provide consent

Primary outcomes:
measure: knowledge of pesticide safety behaviors
timeFrame: 7 weeks
measure: Self-protective behaviors
timeFrame: 7 weeks
Secondary outcomes:
measure: Neurological functioning
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT02334332: Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery
Official title: Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Gastric Carcinoma
Stress
Keywords: Caregiver
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.

SECONDARY OBJECTIVES:

I. To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.

OUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.

COHORT I: Participants receive standard post-operative care.

COHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.

After completion of study, participants are followed up for approximately 2 months.

Eligibility criteria: Inclusion Criteria:

* Patients will be accrued using the following inclusion criteria:

  * Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer
  * Able to read and understand English
* Informal Caregivers will be accrued using the following inclusion criteria:

  * The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
  * Able to read and understand English
* All participants must have the ability to understand the willingness to provide informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Primary outcomes:
measure: Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention
timeFrame: Up to 2 months
Secondary outcomes:
measure: Change in mean survey scores
timeFrame: Baseline up to 4 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304732: Totally Implantable Catheters in Pediatric Hematology-oncology: a Study on Infectious Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric oncology patients with diagnosis of catheter infection

Brief summary: This is a retrospective analysis of infection on catheters of pediatric oncology patients.


Eligibility criteria: Inclusion Criteria:

* patients admitted between Jan/2008 and Dec/2009

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Grupo de Apoio ao Adolescente e a Criança com Cancer
Study officials:
affiliation: Grupo de Apoio ao Adolescente e a Crianca com Cancer
name: Orlei Araujo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06307132: Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules
Official title: A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bioequivalence Trial
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；
2. Signed the informed consent form, and fully understood the content, process and risks of this research, and be able to communicate well with the researchers.

Exclusion Criteria:

1. Female subjects who are menstruating (which may affect urine sample collection);
2. The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.

Primary outcomes:
measure: Excretion volume
timeFrame: Within 12 hours after taking medication
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ting Li, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04123132: Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Official title: Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kinesiophobia
Metabolic Syndrome
Keywords: kinesiophobia
metabolic syndrome
exercise
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 96
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45-65 years old men and female with metabolic syndrome and healthy controls

Brief summary: Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS.

Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Patients with metabolic syndrome

Exclusion Criteria:

* Patients with rheumatic disease
* Patients with neurologic disease
* Patients with history of trauma
* Patients with gonartrosis
* Pateints with fibromialgia

Primary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Dilek Eker Büyükşireci
state: Central Anatolia
Study officials:
References:
Clinical trial NCT03579732: EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan
Official title: EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Low-dose aspirin,
Cancer prevention
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 4710504
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.

Brief summary: The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.

Detailed description: The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.

Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.

Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.

Eligibility criteria: Inclusion Criteria:

* Age 40 or older at the cohort entry date.
* Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.

Exclusion Criteria:

* Subjects with any cancer diagnosis before cohort entry date.
* No use of National Health Insurance before the cohort entry date.
* Low dose aspirin prescription before cohort entry date.
* Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.

Primary outcomes:
measure: Number of subjects with colorectal cancer
timeFrame: Up to 14 years
measure: Number of subjects with esophageal cancer
timeFrame: Up to 14 years
measure: Number of subjects with gastric cancer
timeFrame: Up to 14 years
Secondary outcomes:
measure: Duration of aspirin use to colorectal cancer
timeFrame: Up to 14 years
measure: Time from aspirin discontinuation to colorectal cancer
timeFrame: Up to 14 years
measure: Stage of colorectal cancer
timeFrame: Up to 14 years
measure: Number of fatal cases due to colorectal cancer
timeFrame: Up to 14 years
Other outcomes:
Locations:
city: Taipeh
country: Taiwan
facility: National University of Taiwan Hospital
Study officials:
References:
Clinical trial NCT01313832: The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Septal Defect
Pulmonary Hypertension
Keywords: ventricular septal defect
remote ischemic preconditioning
pulmonary hypertension
infant with ventricular septal defect and pulmonary hypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 60
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief ischemia to the target organ before a subsequent critical ischemia, and its effect has been confirmed. However, its clinical application is not easy because ischemic insult may aggravate the function of vulnerable organ.

On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by applying ischemia to other less vulnerable organ such as skeletal muscle before critical ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults and children. However, Little is known about the effect of remote ischemic precondition on the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the children remains to be further evaluated because the degree of ischemia-reperfusion injury is different according to age, cardiac pathology and cyanosis. In addition, the previous report on children dealt with a diverse range of congenital heart defects with a wide age range. The purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary protection in infants with pulmonary hypertension who need repair of simple ventricular septal defect.


Eligibility criteria: Inclusion Criteria:

* perimembranous or muscular outlet or muscular inlet ventricular septal defect
* pulmonary hypertension (+)
* infant (\<1 year)

Exclusion Criteria:

* subarterial ventricular defect
* chromosomal defect
* airway or parenchymal lung disease
* blood disorder
* anticipation of cardiac muscle resection

Primary outcomes:
measure: troponin level
timeFrame: within the 1 day after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
citation: Lee JH, Park YH, Byon HJ, Kim HS, Kim CS, Kim JT. Effect of remote ischaemic preconditioning on ischaemic-reperfusion injury in pulmonary hypertensive infants receiving ventricular septal defect repair. Br J Anaesth. 2012 Feb;108(2):223-8. doi: 10.1093/bja/aer388. Epub 2011 Dec 8.
Clinical trial NCT00871832: Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality
Official title: To Evaluate if Pre-admission Hyperglycemia Measured by Glycosylated Hemoglobin Level Affects the Morbidity and Mortality of Patients in a Mixed Medical and Surgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: hyperglycemia
HgA1c
mortality
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2009-03-30
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: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.

Brief summary: It is currently standard of care in many Medical and Surgical ICU's to institute a nurse driven insulin protocol in maintaining tight glucose control in the critical patient. Many articles have been written to address this topic. However, there is no current data regarding the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we would like to determine whether or not the HbA1C could be used as a marker of morbidity and mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube; a blood sample that critical patients have drawn up to several times a day. The investigators would analyze this information in respect to the rest of the clinical data collected regarding the patient's illness.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.

Primary outcomes:
measure: morbidity and mortality
timeFrame: at time of review
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Mario Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References: