louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01648309: Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
Official title: Neuropsychological Testing in Patients Undergoing TAVI
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aortic Stenosis
Keywords: aortic stenosis
TAVI
neuropsychological
cognitive
candidates for TAVI
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 60
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 severe aortic stenosis that are candidates for TAVI

Brief summary: The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time.

The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.


Eligibility criteria: Inclusion Criteria:

* All patients with severe aortic stenosis that are candidates for TAVI
* Able to perform the testing
* Able to sign informed consent

Exclusion Criteria:

* Language barriers precluding the administration of the testing
* Existing dementia
* Existing disease limiting life expectancy to less than 180 days

Primary outcomes:
measure: net change in neuropsychological tests between baseline and day 180 from TAVI
timeFrame: 180 days
Secondary outcomes:
measure: net difference between cognitive measures before TAVI and at day 30 after TAVI
timeFrame: 30 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Ronen R Leker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000209: Buprenorphine Dosing Interval - 5
Official title: Buprenorphine Dosing Interval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the feasibility of extending the dosing interval of well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week dosing.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Drug use
measure: Withdrawal symptoms
measure: Opiate and cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3): 220-222). (1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3):220-222).
Clinical trial NCT04841109: Diaphragm Movement During Its Postural Function
Official title: Analysis of Diaphragm Movement During Its Postural Function Using M-mode Ultrasonography in Conjunction With Spirometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Movement
Keywords: diaphragmatic motion
m-mode ultrasonography
postural function
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: The aim of this study is to describe the movement of the diaphragm during postural activation of the trunk muscles in comparison with tidal breathing.

Detailed description: Diaphragm movement will be measured by m-mode ultrasonography in a standing position. 30-35 healthy subjects will participate in the study. The movement of the diaphragm will be measured during tidal breathing then, during holding a load corresponding to 20% of the subject´s body weight and finally, during voluntary contraction of the trunk muscles. Trunk muscles contraction will be measured by a special device with pressure sensors placed on a trunk surface. Breathing activity will be measured by spirometry.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Able to comply with the study protocol, in the investigator's judgment
* Aged 20-40 years, inclusive
* Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination
* Waist-to-height ratio \< 0,59

Exclusion Criteria:

* Low back pain (acute or chronic)
* Previous abdominal or spine surgery
* Acute or chronic respiratory or musculoskeletal disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study
* Pregnancy

Primary outcomes:
measure: Diaphragm movement
timeFrame: 6 months
Secondary outcomes:
measure: Tidal volume
timeFrame: 6 months
measure: Activity of the trunk muscles
timeFrame: 6 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Pavel Kolar´s Centre of Physical Medicine
Study officials:
affiliation: Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
name: Pavel Kolar, Prof, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04630509: Epidemiology and Outcome of Pediatric Traumatic Cataract
Official title: Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Cataract
Keywords: pediatric ocular trauma
Posterior chamber intraocular lens
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 34
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children admitted for traumatic cataract surgery at Assiut university hospital

Brief summary: this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.

Detailed description: Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation.

Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome.

Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.

Eligibility criteria: Inclusion Criteria:

* All children who have undergone traumatic cataract surgery at Assiut university over 1 year period.

Exclusion Criteria:

* children with posterior segment injury.
* children who did not complete at least 6 months of postoperative follow-up.

Primary outcomes:
measure: Demographics
timeFrame: 6 months
measure: Mechanism of injury
timeFrame: 6 months
measure: Visual outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Salma Kedwany, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kedwany SM, Saleh MGA, Tohamy D, Mostafa MM. Outcome of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study. Clin Ophthalmol. 2021 Apr 16;15:1583-1589. doi: 10.2147/OPTH.S282080. eCollection 2021.
Clinical trial NCT06388785: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia
Official title: Post-vaccination Surveillance for Monitoring the Adverse Events Following Immunisation With QDENGA in a Real-world Setting in Malaysia (PRIME-Q)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dengue Fever
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have received the QDENGA vaccine in Malaysia and provided informed consent to participate in the active surveillance and data collection will be included in the study.

Brief summary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.

No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate.


Eligibility criteria: Inclusion Criteria:

1. Participants who have received at least one dose of QDENGA vaccine in Malaysia during the study period.
2. Participants or their legally authorized representative (LARs) with a functioning phone number.

Exclusion Criteria:

No exclusion criteria will be applied for this study.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From 14 days after first vaccination up to 15 months
Secondary outcomes:
measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP)
timeFrame: From 14 days after first vaccination up to 15 months
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04845685: A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus
Official title: Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.

Detailed description: Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.

Eligibility criteria: Inclusion Criteria:

* Patients with Type 1 or 2 Diabetes Mellitus.
* Patients 18 years of age or older.
* Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery.
* Anticipated minimum of 72h hospital stay.
* Patients on insulin therapy (IV, SQ) post-surgery.

Exclusion Criteria:

* Active COVID-19 infection.
* Pregnant or lactating female.
* Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve).
* Inability to provide informed consent.
* Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours.

Patients with skin lesions at the application site that may interfere with placement of the sensor.

Patients with known allergy to medical grade adhesive.

Primary outcomes:
measure: CGM accuracy
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
Secondary outcomes:
measure: CGM recorded hypoglycemia episodes
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: CGM recorded hyperglycemia episodes
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Adrian Dumitrascu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702985: Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer
Official title: A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Keywords: Neoadjuvant Chemoradiotherapy
amifostine
irinotecan
capecitabine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 160
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: PREVENTION

Brief summary: The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.


Eligibility criteria: Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7

Primary outcomes:
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
timeFrame: during neoadjuvant chemoradiation.
Secondary outcomes:
measure: Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire
timeFrame: during neoadjuvant chemoradiation.
measure: pathological response rate
timeFrame: Surgery scheduled 6-8 weeks after the end of chemoradiation.
measure: the morbidity of late radiation proctitis
timeFrame: late radiation proctitis is measured 9 months after the end of chemoradiation.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06228885: Investigating Handwriting Characteristics and Underlying Factor in Children With Autism Spectrum Disorder
Official title: Investigating the Unique Motor Characteristics and Corresponding Cortical Activation During Handwriting -- in 5-12 Year-old Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children With Autism Spectrum Disorder
Typical Developed Children
Keywords: Autism
Handwriting
Kinetic and kinematic
Cortical activation
Sensorimotor
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with ASD group:

* Meeting the criteria for ASD according to DSM-5 from psychiatrist
* ASD core symptoms: CARS higher than 30

TD group:

- The percentage score of MABC-2 is larger than 25% (not determined as "impaired motor coordination")

Brief summary: The mechanism of the motor problem in children with autism spectrum disorder (ASD) in handwriting has been investigated in the following three aspects, including collecting dynamic handwriting performance, exploring the related underlying factors, and investigating corresponding brain activities. This study aimed to investigate the underlying factor of handwriting issue in children with ASD. There are four study aims. The first is to examine the differences of handwriting performance between children with ASD and TD using kinetic and kinematic measurements and handwriting difficulties questionnaires. The second is to investigate the group difference of the underlying motor factors, including fine motor ability and sensorimotor ability. The third is to explore the relationship between underlying motor factors and handwriting performance. The fourth is to explore the corresponding cortical activity during writing in children.


Eligibility criteria: Inclusion Criteria:

* Age between 5-12 years old

Exclusion Criteria:

* who have a diagnosis of a seizure disorder, genetic condition, neurological condition, uncorrected significant hearing or visual impairment, and/or intellectual disability
* having non-verbal intelligent ability score lower than 70, determining by TONI-3
* unable to follow instructions during the process

Primary outcomes:
measure: Force-acquisition pen (FAP) system
timeFrame: baseline
measure: Pinch-Holding-Up Activity (PHUA) test
timeFrame: baseline
measure: Movement Assessment Battery for Children Second Edition (MABC-2)
timeFrame: baseline
measure: Chinese Handwriting Evaluation Form (CHEF)
timeFrame: baseline
Secondary outcomes:
measure: Near Infrared Spectroscopy (NIRS)
timeFrame: baseline
Other outcomes:
measure: Test of Nonverbal Intelligence, Third Edition (TONI-3)
timeFrame: baseline
measure: Childhood Autism rating scale (CARS)
timeFrame: baseline
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
Clinical trial NCT03129685: Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
Official title: Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Devascularization
Lead sponsor: The National Ribat University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective and non-randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

Detailed description: Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.

Eligibility criteria: Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
* Other associated surgical procedure;

Primary outcomes:
measure: Short term mortality rate
timeFrame: 30 day
Secondary outcomes:
measure: Short term major complications' rate
timeFrame: 30 days
measure: Tumor response rate according to mRECIST criteria.
timeFrame: 30 days
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Ribat University Hospital
Study officials:
affiliation: Faculty of Medicine. The National Ribat University
name: Osama M Elsanousi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsanousi OM, Mohamed MA, Salim FH, Adam EA. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29.