louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03223688: Early Intervention for Developmental Delay
Official title: Effectiveness of Adjunctive Sensory Integration Therapy for Children With Developmental Delay in an Early Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Developmental Delay
Early Intervention
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.

Detailed description: This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.

Eligibility criteria: Inclusion Criteria:

* Children with Developmental Delay
* The caregivers are able to participate in the treatment program

Exclusion Criteria:

* Autism
* Cerebral palsy

Primary outcomes:
measure: Changes of children's development
timeFrame: Assessment will be performed at baseline and 6-month after the baseline
Secondary outcomes:
measure: Changes of caregivers' life quality
timeFrame: Assessment will be performed at baseline and 6-month after the baseline
measure: Changes of caregivers' parenting stress
timeFrame: Assessment will be performed at baseline and 6-month after the baseline
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital, Kaohsiung, Taiwan
name: Liang-Jen Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04957888: Microbial Markers for AGI
Official title: Investigation on the Microbial Biomarkers of AGI in the Early Stage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Gastrointestinal Injury
Keywords: microbiome
metabolome
biomarker
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2021-07-12
Enrollment: 584
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology.


Eligibility criteria: Inclusion Criteria: All those critically ill patients with anticipated ICU stay for more than 2 days Exclusion Criteria:Patients will be excluded if they have any of the following situations: patients who have not signed the informed consent; Unable to tolerate intra-abdominal pressure monitoring; pregnant woman; Patients after bladder surgery; Systemic diseases and recent use of related drugs; He had a history of infectious diseases, such as tuberculosis or PPD positive. History of hypertension and poor blood pressure control (SBP / DBP \> = 140mmHg); Patients with severe mental illness; Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission.

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Primary outcomes:
measure: The AUC value of the combined markers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04787588: COVID-19 Infection and Epithelial Cell Markers
Official title: COVID-19 Infection and Epithelial Cell Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Covid19
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: To assess if TSLP expression by airway epithelial cells following COVID-19 infection regulates viral load and disease severity.

Detailed description: The study aim is to determine the relationship between COVID-19 infection and epithelial cell expression of TSLP. Two cohorts will be used. Cohort One will include 100 hospitalized patients with Covid-19, and 100 hospitalized patients without Covid-19. Cohort 2 will include mild/moderate asthmatics and healthy controls with bio-banked biopsy material used from donors who have previously consented for samples to be used for future research.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and above;
* Able to give informed consent;
* Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The control group will be patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. In addition, the control group should have NO known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
* Able to provide a breath sample (as based on clinical judgement).

Exclusion Criteria:

- none

Primary outcomes:
measure: TSLP expression in nasal epithelium
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: TSLP expression in endobronchial biopsies
timeFrame: Baseline
measure: IL-33 expression in endobronchial biopsies
timeFrame: Baseline
measure: ACE-2 receptor expression in endobronchial biopsies
timeFrame: Baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Cardio-Respiratory Research Lab
state: Ontario
Study officials:
affiliation: McMaster University Hospital
name: Gail Gauvreau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409888: Evaluating Interventions for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Syracuse University
name: Pacific Institute for Research and Evaluation
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2015-04-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.


Eligibility criteria: Inclusion Criteria: Study inclusion criteria are such that study participants must:

1. meet a Diagnostic and Statistical Manual-IV (DSM-IV) alcohol abuse or dependence diagnosis based on the Diagnostic Interview Schedule - IV (DIS-IV);
2. consume a weekly average of at least 24 standard drinks during the baseline period to include at least 5 episodes of heavy drinking;
3. agree not to seek additional alcohol or other substance abuse treatment during the study period;
4. be at least 18 years of age; and
5. be sufficiently proficient in their English speaking ability to interact effectively with the research interviewer.

Exclusion Criteria:

* Individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, IV drug use),
* a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the DIS-IV will be precluded from study participation.

In addition,

* individuals reporting current enrollment in a substance abuse treatment program,
* mandated to substance abuse treatment by a court order, or
* severely socially unstable (e.g., homeless) also will be precluded from study participation.

Primary outcomes:
measure: Alcohol Use
timeFrame: One year post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University School of Public Health
state: New Jersey
Study officials:
affiliation: Rutgers University School of Public Health
name: Patrick R Clifford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009188: Genetic Findings in a Chinese Family With Axenfeld-Rieger Syndrom
Official title: Genetic Findings in a Chinese Family With Axenfeld-Rieger Syndrom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Findings in a Chinese Family With ARS
Keywords: Axenfeld-Rieger syndrom, genetic findings
Lead sponsor: Aier Eye Hospital, Changsha
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nine members of two genetions of a Chinese family with ARS

Brief summary: Axenfeld-Rieger syndrome (ARS) is a rare autosomal dominant disorder, characterized by anterior segment abnormalities and systemic abnormalities. To date,two major genes, forkhead box C1 (FOXC1) on chromosome 6p25 and pituitary homeobox 2 (PITX2) on chromosome 4q25, have been demonstrated to cause ARS. In this study, we performed complete ophthalmologic examinations and analysis of FOXC1 and PITX2 of a Chinese family with ARS.

Detailed description: Two genetions of a Chinese family with ARS were recruited to Aier Eye Hospital of Changsha.

Clinical evaluations: We performed full ophthalmologic examinations of all subjects, including: visual acuity, intraocular pressure measurements (Goldman), slit lamp, anterior segment photography, visual field test (Humphrey 750, Carl Zeiss, Germany), Anterior segment OCT (Carl Zeiss, Germany). If the refractive medium is clear, we also performed funduscopy, gonioscopic and retinal nerve fiber layer (RNFL) thickness measurements (Carl Zeiss, Germany).

Mutation analysis: About 2 ml of venous blood sampled from each subject and collected in Vacutainer tubes (Sanjiu Medical Technology Co., Ltd., Liuyang, China) containing EDTA. Genomic DNA was extracted from each blood using a genomic DNA mini kit for blood (Life Technologies), All coding exons, with flanking intronic regions, of FOXC1 and PITX2 were amplified using PCR with primers. The amplifed DNA was purifed by agarose gel electrophoresis and sequenced on a 3730/3700xl automated DNA sequencer (Applied Biosystems).

Eligibility criteria: Inclusion Criteria:

* a Chinese family with ARS

Exclusion Criteria:

-

Primary outcomes:
measure: Novel genetic findings in a Chinese family with Axenfeld-Rieger syndrom
timeFrame: Dec 1, 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05819788: FFP Usage in Pediatric CV Surgery
Official title: Outcomes of Fresh Frozen Plasma Usage During Cardiopulmonary Bypass in Congenital Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulopathy
Congenital Heart Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 431
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients between 4 and 8 kilograms with congenital cardiac defects

Brief summary: When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.

Detailed description: This will be a single center, retrospective study. Our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between January 2019 and January 2023. Patients will be divided into two groups: FFP given at onset of CPB and no FFP given intraoperatively. Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded. Patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using REDCAP and via chart review using Connect Care.

Eligibility criteria: Inclusion Criteria:

* pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded

Primary outcomes:
measure: Transfusion
timeFrame: 24 hours
measure: Bleeding
timeFrame: 24 hours
Secondary outcomes:
measure: Length of ventilation
timeFrame: 5 days
measure: Length of stay
timeFrame: 5 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Mancho Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710188: Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation
Official title: A Phase 1 Relative Bioavailability Study in Healthy CYP2D6 Intermediate (IM) and Extensive Metaboliser (EM) Subjects, Designed to Evaluate the Pharmacokinetic (PK) Profile of HTL0009936 Following Single Dose Administration of Modified Release (MR) Prototype Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Nxera Pharma UK Limited
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2016-03-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.

Detailed description: The aim of the study is to develop a modified release oral tablet formulation that maintains plasma concentrations within the target therapeutic range, and is safe and tolerable.

Eligibility criteria: Inclusion Criteria:

* Healthy males \& females
* Aged 18 to 65 years
* Body mass index of 18.0 to 35.0 kg/m2
* CYP2D6 (intermediate or extensive metabolizer)

Exclusion Criteria:

* Subjects with a resting heart rate (HR) \>90 bpm, and/or systolic blood pressure (BP) \>150 mmHg, and/or diastolic BP \>90 mmHg
* Subjects with QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 ms (males) or \>470 ms (females)
* Personal or family history of long QT syndrome or sudden death
* Subjects who are CYP2D6 (poor or ultra-rapid metabolizer)

Primary outcomes:
measure: Tlag
timeFrame: 14 weeks
measure: Frel
timeFrame: 14 weeks
measure: Tmax
timeFrame: 14 weeks
measure: Cmax
timeFrame: 14 weeks
measure: Concentration of HTL0009936 at 6 hours post dose (C6)
timeFrame: 6 hours post dose
measure: AUC (0-last)
timeFrame: 14 weeks
measure: AUC (0-inf)
timeFrame: 14 weeks
measure: AUC%extrap
timeFrame: 14 weeks
measure: Lambda-z
timeFrame: 14 weeks
measure: T1/2
timeFrame: 14 weeks
measure: Dose normalized AUC
timeFrame: 14 weeks
measure: Dose normalized Cmax
timeFrame: 14 weeks
measure: Concentration of HTL0009936 at 12 hours post dose (C12)
timeFrame: 12 hours post dose
measure: Concentration of HTL0009936 at 24 hours post dose (C24)
timeFrame: 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
affiliation: Quotient Clinical
name: Litza McKenzie, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770088: Vunakizumab in Adults with Spondyloarthritis
Official title: A Prospective, Single-arm, Multicenter Study to Explore the Efficacy and Safety of Vunakizumab in Adults with Active Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spondyloarthritis (SpA)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.


Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years when signing the informed consent;
2. Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;
3. The subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study.

Exclusion Criteria:

1. Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;
2. fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug;
3. active infection with important clinical significance;
4. patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);
5. patients with malignant tumors who were receiving treatment or were not receiving treatment;
6. concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment;
7. any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.

Primary outcomes:
measure: Proportion of patients with spondyloarthritis who achieved ASAS40 response
timeFrame: week 16
Secondary outcomes:
measure: The proportion of patients achieving ASAS20
timeFrame: Week 16
measure: Proportion of patients with spondyloarthritis who achieved ASAS20 response
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06728488: Comparison of the Analgesic Efficacy and Duration of Analgesic Effect of Pericapsular Nerve Group Block Block Application With PENG Block and Pulse Radiofrequency Ablation in Chronic Hip Pain
Official title: Comparison of the Analgesic Efficacy and Duration of Analgesic Effect of PENG Block Application With PENG Block and Pulse Radiofrequency Ablation in Chronic Hip Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Pain Chronic
Keywords: hip pain chronic
Radiofrequency ablation
PENG block
vNRS (Verbal Numerical Rating Scale)
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Scientific Research Projects Coordination Unit
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.
Primary purpose: TREATMENT

Brief summary: Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.

Detailed description: Patients with chronic hip pain will be divided into two groups, and after providing the necessary information, informed consent forms will be obtained for inclusion in the study from both groups. The 'Verbal Numerical Rating Scale (vNRS)' will be assessed before the procedure. Patients to undergo PENG block and PENG block with pulse radiofrequency ablation will be monitored prior to the procedure. After the procedure, they will be monitored for 3 hours under observation. At the third hour after the procedure, before leaving the operating room, and at the 1st and 3rd months, patients will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated. This will allow the comparison of the effects of PENG block and PENG block with pulse radiofrequency ablation on pain management in chronic hip pain.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic hip pain Aged 18-80 ASA I-III patients

Exclusion Criteria:

* Patients with allergies to the medications used, severe cardiac, renal, pulmonary, liver, and endocrine diseases, patients with uncontrolled blood sugar levels (diabetes mellitus), patients who have used anticoagulant medications in the last five days, patients with bleeding or clotting disorders, those with implanted medical devices such as pacemakers and defibrillators, patients with infections at the procedure site, patients with psychiatric disorders or communication difficulties, patients with missing data, and patients who do not wish to undergo regional block are defined as exclusion criteria.

Primary outcomes:
measure: vNRS Verbal Numerical Rating Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: