louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02999451: Snare-assisted POEM for Treatment of Esophageal Achalasia
Official title: Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Achalasia
Keywords: Peroral endoscopic myotomy
Snare
Endoscopic knife
Esophageal Achalasia
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.


Eligibility criteria: Inclusion Criteria:

* Age between 18-70 years
* Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
* Signed written informed consent

Exclusion Criteria:

* ASA class \> Ⅲ
* Previous endoscopic or surgical treatment for achalasia
* Esophageal malignancy
* Pregnant

Primary outcomes:
measure: Clinical success rates
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Procedure-related adverse events
timeFrame: baseline to 12 months after treatment
measure: Procedure time
timeFrame: POEM procedure
measure: The volume of intraoperative bleeding
timeFrame: POEM procedure
measure: The use of hemostatic forceps
timeFrame: POEM procedure
measure: Postoperative pain requiring the use of tramadol
timeFrame: Through hospital stay after procedure, an average of 2-7 days
measure: The length of postoperative hospital stay
timeFrame: Through hospital stay after procedure, an average of 2-7 daysc
measure: Total hospital costs of treatment per participants
timeFrame: Through hospital stay after procedure, an average of 2-7 days
measure: Eckardt score
timeFrame: baseline, 3 months and 12 months after treatment
measure: Manometry parameters
timeFrame: baseline and 3 months after treatment
measure: Maximum esophageal diameter on barium esophagram
timeFrame: baseline and 3 months after treatment
measure: Gastroesophageal reflux disease questionnaire (GerdQ) score
timeFrame: baseline, 3 months and 12 months after treatment
measure: Reflux esophagitis on post-POEM endoscopy
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xiangbin Xing, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02162251: Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Desease
Keywords: Alzheimer's Disease
donepezil hydrochloride
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 3482
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's Disease

Brief summary: To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.


Eligibility criteria: Inclusion criteria:

Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Primary outcomes:
measure: Investigations on adverse events and adverse drug reactions
timeFrame: Up to 12 months
Secondary outcomes:
measure: Severity of dementia based on the Functional Assessment Staging Test (FAST)
timeFrame: Baseline, Month 3, Month 6, and Month 12
measure: Change From Baseline in the Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
citation: Geriatric Medicine 55(1): 87-100, 2017.
citation: Geriatric Medicine 55(11): 1251-1264, 2017.
Clinical trial NCT05845151: Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis
Official title: Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lupus Nephritis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.


Eligibility criteria: Inclusion Criteria:

* Be between 18-80 years old;
* Confirmed SLE: meet the 2019 EULAR/ACR classification standards;
* There are signs of renal involvement and indications for renal puncture: proteinuria\> 0.5g/24 hours (or urine protein creatine ratio (UPCR) \>500mg/g), unexplained decrease of glomerular filtration rate (GFR)

Exclusion Criteria:

* The pathology of renal puncture is not consistent with lupus nephritis;
* Previous history of other kidney diseases;
* There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;
* History of malignant tumors within 5 years.

Primary outcomes:
measure: Renal FAP expression level
timeFrame: Baseline
measure: Renal FAP expression level
timeFrame: 6 months after baseline
measure: Renal FAP expression level
timeFrame: 12 months after baseline
measure: Renal FAP expression level
timeFrame: 24 months after baseline
Secondary outcomes:
measure: Renal fibrosis score
timeFrame: Baseline
measure: Chronic activity score
timeFrame: Baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Hui Shi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03815851: Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
Official title: Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI et al) in Crohn's Patients After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial
Primary purpose: PREVENTION

Brief summary: For patients with Crohn's diseases，whether prophylactic abdominal drainage is necessary need further exploration. the present study is focusing on the necessity of prophylactic abdominal drainage in CD patients after surgery.

Detailed description: In the past decades, surgical dogma meant the correct placement of a prophylactic drain, with the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation and avoiding potential postoperative ascites. However, recent randomized controlled trials (RCTs) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits on postoperative outcomes.

Crohn's disease (CD), which is definitely different from CRC, is a chronic inflammatory disease with unknown pathogenesis. CD itself was the independent risk factor of multiple postoperative complications, including anastomotic leakage, intraperitoneal abscess and catheter-associated bloodstream infection.

In the present RCT, we hypothesize that non-prophylactic peritoneal drainage is associated with increased incidence of postoperative non-septic complications.

Eligibility criteria: Inclusion Criteria:

* Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.

Exclusion Criteria:

* Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose \>126 mg/dL), as well as chronic systemic disease of cardiovascular, respiratory et al.
* Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.

Primary outcomes:
measure: incidence of prolonged postoperative ileus
timeFrame: postoperative 30 days
Secondary outcomes:
measure: recurrence
timeFrame: postoperative 30 days and 1 year after surgery for endoscopic recurrence.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: weiming zhu
role: STUDY_CHAIR
References:
Clinical trial NCT00182351: D-Dimer Vs Serial Compression Ultrasound Study
Official title: Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Keywords: deep vein thrombosis
d-dimer
serial compression ultrasound
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2005-09-16
Enrollment: 810
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis


Eligibility criteria: Inclusion Criteria:

* first suspected deep vein thrombosis
* no previous venous thromboembolism
* referred to thromboembolism outpatient clinic

Exclusion Criteria:

* comorbid condition limiting survival to less than six months
* contraindication to venography (contrast allergy, etc.)
* receiving long term warfarin therapy
* receiving full dose heparin therapy for more than 48 hours
* absence of symptoms during the five days immediately prior to presentation
* symptoms of pulmonary embolism
* pregnancy
* geographic inaccessibility which precludes follow-up

Primary outcomes:
measure: safety of withholding anticoagulants
Secondary outcomes:
measure: deep vein thrombosis
measure: pulmonary embolism
measure: death
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences and McMaster University
name: Clive Kearon, MB
role: STUDY_CHAIR
References:
citation: Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005 Apr 5;142(7):490-6. doi: 10.7326/0003-4819-142-7-200504050-00007.
Clinical trial NCT04346251: Correlation Between Refraction and Biometric Parameters
Official title: Correlation Analysis of Refraction and Biometric Parameters in Chinese Schoolchildren
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schoolchildren aged 6 to 15 years will be included in this cross-sectional study.

Brief summary: To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

Detailed description: In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).

Eligibility criteria: Inclusion Criteria:

* Schoolchildren aged from 6 to 15 years

Exclusion Criteria:

* with previous histories of cataracts, keratitis, strabismus, or other visual impairments
* with history of previous eye surgery
* with unreliable auto-refraction values
* unwilling to participate

Primary outcomes:
measure: refractive error in diopters and biometric Parameters
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05408351: The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
Official title: The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Child Development Disorder
Development Delay
Developmental Delay
Global Developmental Delay
Motor Delay
Speech Delay
Keywords: ASQ-3
BSID-III
child development
Indonesia
screening test
validity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 131
Sex: ALL
Minimum age (years): 23
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parents with children aged 23-38 months living in Central Jakarta.

Brief summary: This study aimed to evaluate the concurrent validity information of the 24-, 30-, and 36-month Indonesian ASQ-3 with the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III) in Indonesian children. Children living in Tanah Tinggi subdistrict, Central Jakarta, were recruited conveniently from November to December 2019. Children within the 24-, 30-, or 36-month age group were assessed for Indonesian ASQ-3 concurrently with BSID-III as the reference standard according to their age groups. Screening test accuracy was measured in sensitivity, specificity, and predictive values for both overall dan specific domains.


Eligibility criteria: Inclusion Criteria:

* Parents with children aged 23 - 38 months
* Parents who finished at least elementary school

Exclusion Criteria:

* Parents with communication difficulties
* Parents who could not speak Indonesian language

Primary outcomes:
measure: Child development
timeFrame: Day 1
measure: Child development
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Tanah Tinggi subdistrict community health centers
Study officials:
References:
Clinical trial NCT01184651: Tweens to Teens Project at Penn State
Official title: "Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Adrenal Hyperplasia
Keywords: Congenital Adrenal Hyperplasia
CAH
sex differences
adolescence
androgen
behavior
gender development
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-08-19
Enrollment: 188
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will study girls with the 21-hydroxylase deficiency (21-OHD) form of congenital adrenal hyperplasia (CAH) aged 10 to 13. Parents of participants are also included.

Brief summary: The goal of this study is to help investigators to understand more about the development of characteristics related to being male or female (what is called gender development). The investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to learn more about the girls' interests and activities, thoughts and feeling about being female, and family relationships. This will help investigators to understand the ways in which gender development is shaped by hormones and family relationships.

Detailed description: Interviewers will visit girls in their home when it is convenient for the family. Girls will answer questions about the things they do and are interested in, how they think and feel, and complete some cognitive tasks. Girls will also provide saliva so we can examine their hormones and determine the CAH gene mutation they have. Parents will also be asked to complete questionnaires about their own activities and interests and about their daughter's behavior.

Shortly after the home visit, interviewers will telephone girls and their parents on several days and ask what the girls did during the day.

Eligibility criteria: Inclusion Criteria:

* Girls with classical or non-classical CAH due to 21-OHD
* Girls will be aged 10-13 years at initial recruitment
* Parents will include biological mothers and fathers as well as step-parents and/or other guardians/significant caregivers
* Parents/guardians may range in age from 18 years of age to 65 years of age.

Exclusion Criteria:

* Girls who are not within the age range of 10-13 years old at initial recruitment
* CAH not due to the 21-OHD form

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Sheri A Berenbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660551: Investigation of the Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia
Official title: Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dystocia
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students.

H01: There is no difference between the four groups in terms of satisfaction with learning.

H02: There is no difference between the four groups in terms of Self-Confidence in Learning.

H03: There is no difference between the four groups in terms of Motivation scores in Teaching Materials.


Eligibility criteria: Inclusion Criteria:

* Being a registered student in the midwifery department,
* Having the ability to manage normal birth,
* Having a smart phone, tablet or computer with internet connection,
* Agreeing to participate in the research

Exclusion Criteria:

* to suspend education.
* Having received formal training on shoulder dystocia management.

Primary outcomes:
measure: Shoulder Dystocia Skill Checklist
timeFrame: 15 days after the training
measure: Instructional Materials Motivation Survey
timeFrame: 15 days after the training
measure: Change in Self-Sufficiency
timeFrame: immediately before the training, immediately after the training
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Nursing
Study officials:
References: