louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01570231: Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Official title: Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bilateral Limb Ischemic Preconditioning
Intracranial Arterial Stenosis
Keywords: remote ischemic preconditioning
octogenarian
intracranial arterial stenosis
stroke recurrence
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Capital Medical University
First posted: 2012-04-04
Enrollment: 58
Sex: ALL
Minimum age (years): 80
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.


Eligibility criteria: Inclusion Criteria:

1. age between 80 to 95 years old
2. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
3. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4
4. ABCD2 score between 6 to 7
5. stable vital signs, normal hepatic and renal functions
6. no hemorrhagic tendencies

Exclusion Criteria:

1. within 72 hrs of intra-artery or intravenous thrombolysis
2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
4. acute myocardial infarction
5. systolic blood pressure more than 200 mmHg after drug control
6. peripheral blood vessel disease
7. hematologic disease
8. severe hepatic and renal dysfunction
9. severe or unstable concomitant disease
10. cannot tolerate BLIPC or without informed consent

Primary outcomes:
measure: objective signs of tissue or neurovascular injury
timeFrame: 180 days after treatment
measure: levels of plasma biomarkers
timeFrame: 180-day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University
Study officials:
References:
citation: Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
Clinical trial NCT05422131: Clozapine Therapy Sample Collection - Method Comparison Study
Official title: Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Prescribed Clozapine
Lead sponsor: Saladax Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
name: University of Maryland, Baltimore
First posted: 2022-06-16
Enrollment: 153
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 150 unique subjects are required for the collection of at least 150 of each a capillary fingerstick blood, venous serum, and venous K2EDTA blood samples. A subset of at least 75 subjects will require two fingerstick blood samples. Subjects consisting of males and females, at least 21 years of age or older, who meet the protocol Inclusion / Exclusion criteria as described below.

Brief summary: The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.


Eligibility criteria: Inclusion Criteria:

* Study subjects must meet all the following criteria to be eligible for enrollment into the study:

  1. Female or male subjects 21 years of age or older;
  2. Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
  3. Capable of understanding and complying with parameters as outlined in the protocol;
  4. Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures.

Exclusion Criteria:

* 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.

Primary outcomes:
measure: Sample Analysis - Method Comparision
timeFrame: October, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Saladax Biomedical, Inc.
state: Pennsylvania
Study officials:
affiliation: University of Maryland
name: Robert Christenson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03144531: Sleep Intervention for Kids and Parents: A Self-Management Pilot Study
Official title: Sleep Intervention for Kids and Parents (SKIP): A Self-Management Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Asthma
Keywords: School-age child
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-05-08
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dyadic intervention for school-age children and a parent
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance.


Eligibility criteria: Inclusion Criteria (child):

* Children 6-11 years
* Child diagnosis of asthma with prescription for daily medication
* Able to understand English (child)
* Sleep disturbance per CSHQ (child \>= 41) and/or \< 9 hours of sleep per night

Exclusion Criteria (child)

* Parent reported diagnosis of traumatic brain injury, developmental delay, autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), obstructive sleep apnea, cancer
* Positive sleep related breathing disorder screening (obstructive sleep apnea screening)

Inclusion Criteria (parent)

* 18 years or older
* Able to understand and read English
* Lives with child 50% of time or more
* Is child's legal guardian
* Has reliable access to internet
* \>/= 5 on Pittsburgh Sleep Quality Index or \<7 hours overnight reported sleep

Exclusion Criteria (parent)

* Diagnosed obstructive sleep apnea or sleep disordered breathing
* Is a nightshift worker
* Uses sleep medication

Primary outcomes:
measure: Total sleep time
timeFrame: 3 months post intervention (x 10 days of measurement)
measure: Sleep efficiency
timeFrame: 3 months post intervention (x 10 days of measurement)
measure: Bedtime Consistency
timeFrame: 3 months post intervention (x 10 days of measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Nursing
state: Washington
Study officials:
affiliation: University of Washington
name: Jennifer Sonney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonney JT, Thompson HJ, Landis CA, Pike KC, Chen ML, Garrison MM, Ward TM. Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study. J Clin Sleep Med. 2020 Jun 15;16(6):925-936. doi: 10.5664/jcsm.8374.
Clinical trial NCT04046731: Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation
Official title: The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

Detailed description: This study will be a prospective study to accurately determine the negative predictive value of skin testing with NMBAs.

It is hypothesized that the concentrations that should be used for NMBAs are actually much lower than previously recommended and that the higher incidence of identifiable NMBA induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Eligibility criteria: Inclusion Criteria:

* All adults \> or = to 18 y/o undergoing surgery

Exclusion Criteria:

* Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

Primary outcomes:
measure: Non-Irritant Concentrations to common NMBAs
timeFrame: 1 Year
Secondary outcomes:
measure: Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
timeFrame: 1 Year
measure: Max Concentration used when skin testing to NMBAs
timeFrame: 1 Year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alexei Gonzalez Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04583631: Relationship of Endoplasmic Reticulum Stress and Adenoid Diseases
Official title: Relationship Between Apoptosis and er Stress in Chronic Adenoiditis and Adenoid Hypertrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoiditis Acute Infective
Keywords: Adenoidectomy
; Endoplasmic Reticulum
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was performed on 54 patients (28 male, 26 female) between the ages of 3 and 9 (mean 5) with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy and who underwent adenoidectomy due to either chronic adenoiditis or adenoid hypertrophy.

Brief summary: Adenoid tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of cells. The purpose of the study was to explore the correlation among ER stress and adenoid tissue disorders and to explain the structure of diseases related to the immune system.


Eligibility criteria: Inclusion Criteria:

- Patients with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy.

Exclusion Criteria:

* Systemic diseases
* Other otolaryngological

Primary outcomes:
measure: Correlation of ER stress and apoptosis with chronic adenoiditis and adenoid hypertrophy
timeFrame: 2018-2019 (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
citation: Casselbrant ML. What is wrong in chronic adenoiditis/tonsillitis anatomical considerations. Int J Pediatr Otorhinolaryngol. 1999 Oct 5;49 Suppl 1:S133-5. doi: 10.1016/s0165-5876(99)00147-0.
citation: Li R, Wang Y, Chen P, Meng J, Zhang H. Inhibiting endoplasmic reticulum stress by activation of G-protein-coupled estrogen receptor to protect retinal astrocytes under hyperoxia. J Biochem Mol Toxicol. 2021 Feb;35(2):e22641. doi: 10.1002/jbt.22641. Epub 2020 Sep 29.
Clinical trial NCT03885531: Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
Official title: Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Journey II CR Total Knee System
Keywords: Journey II CR Total Knee System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nor Consult
First posted: 2019-03-21
Enrollment: 586
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.

Brief summary: The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.


Eligibility criteria: Inclusion Criteria:

* Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
* The TKA occurred at least 12 weeks prior to enrollment

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of adverse events reported per ISO 14155 guidelines
timeFrame: 7 years
Secondary outcomes:
measure: Length of hospital stay for primary (index) surgery
timeFrame: 7 years
measure: Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
timeFrame: 7 years
measure: Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
timeFrame: upon occurence through 7 years of study duration
measure: Number of rehabilitation sessions
timeFrame: 7 years
measure: Duration of rehabilitation sessions in weeks
timeFrame: 7 years
measure: Number and type of outpatient visits
timeFrame: 7 years
measure: Number of re-operations
timeFrame: 7 years
measure: Quality of Life as measured by EQ-5D-3L score
timeFrame: 7 years
measure: Patient Pain Level as measured by Knee Society Score (KSS)
timeFrame: 7 years
measure: Number of days before return to work
timeFrame: 7 years
measure: Number of technical difficulties encountered with the device
timeFrame: 7 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Orthopaedic Specialists of Scottsdale
state: Arizona
city: Pikeville
country: United States
facility: Pikeville Medical Center
state: Kentucky
city: Reno
country: United States
facility: Reno Orthopedic Institute
state: Nevada
city: New York
country: United States
facility: New York University
state: New York
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinics
state: Tennessee
Study officials:
affiliation: Smith & Nephew, Inc.
name: Sandra Navarrete
role: STUDY_CHAIR
References:
Clinical trial NCT05090631: The Role of Genetic Factors in the Development of Atopic Dermatitis in the Kazakh Population
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: GWAS
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: KAZAKH POPULATION

Brief summary: This is a GWAS study that aims to identify possible candidate genes associate to atopic dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with atopic dermatitis

Detailed description: A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Persons with various forms of a confirmed diagnosis of atopic dermatitis;
* The age of the patients is from 18 to 45+ years;
* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
* Persons who are able and willing to provide written informed consent;
* Persons capable and willing to comply with the research protocol;

Exclusion Criteria:

* Persons under the age of 18;
* Patients with severe concomitant systemic diseases, including cardiovascular, respiratory, hepatic and renal failure
* Patients with severe infectious processes (sepsis, abscess, hepatitis B and C, HIV)
* Persons with mental illness.
* Persons taking corticosteroid drugs, immunosuppressants within the last month;
* Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
* Pregnant or lactating women;
* Tuberculosis of any localization in the active phase and in history;
* Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
* Severe and decompensated course of endocrine diseases;
* Autoimmune diseases;
* Systemic diseases;
* Oncological diseases;

Primary outcomes:
measure: number of SNPs associated with atopic dermatitis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakhstan
Study officials:
affiliation: Asfendiyarov Kazakh National Medical University
name: Gulya Sarybaeva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04945031: The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis
Official title: The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 317
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical chart which diagnosis by ICD-10 with cannabis-induced psychosis who admitted at PMNIDAT from October 2013 to September 2019 at Princess Mother National Institute on Drug Abuse Treatment.

Brief summary: A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included. Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety. Antipsychotic drug was still a key psychotropic drugs for treatment of CIP. However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 12 years of age
* Patients who had been diagnosed as Cannabis-induced psychosis by International statistical Classification of Disease and Related Health problem (ICD-10) on 2016 code F12.5
* Patients had history of use of cannabis in medical chart
* Patients had the positive urine screening test of cannabis at the first day of admission

Exclusion Criteria:

* Patients had psychosis from organic psychosis, defined by diagnosis by ICD-10 code F09.6
* Unavailable data for evaluate of outcome especially data of drug use, content of drug use or urine screening test
* Patients who cancel of medical treatment before 7 day after admission.

Primary outcomes:
measure: Pharmacological treatment pattern for cannabis-induced psychosis
timeFrame: 30 days
Secondary outcomes:
measure: Change of Brief psychiatric rating scale (BPRS) form the first day of admission
timeFrame: Day1, Day 8, Day 15 and Day 22
Other outcomes:
Locations:
city: Thanyaburi
country: Thailand
facility: Onrumpha Chuenchom
state: Pathum Thani
Study officials:
References:
Clinical trial NCT01880931: The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients

Detailed description: It is known that anesthetic agents can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients.

Eligibility criteria: Inclusion Criteria:

* ≥ 50 years ASA class I-II female who received surgery with endotracheal intubation

Exclusion Criteria:

* emergency surgery electrocardiography abnormality diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction

Primary outcomes:
measure: The effect site concentration of remifentanil for preventing QTc interval prolongation
timeFrame: 2 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: So Yeon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: