louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04840485: Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis


Eligibility criteria: Inclusion Criteria:

- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs

Exclusion Criteria:

- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

Primary outcomes:
measure: Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
timeFrame: 16 Weeks
Secondary outcomes:
measure: Percentage of Participants Responded for ASAS 20 Response at 32 Weeks
timeFrame: 32 Weeks
measure: Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks
timeFrame: 16 and 32 Weeks
measure: Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks
timeFrame: 16 and 32 Weeks
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks
timeFrame: 16 and 32 Weeks
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks
timeFrame: 16 and 32 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04541485: To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
Official title: Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19 Patients
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

1. Between 18 and 65 years of age, inclusive at time of signing the ICF.
2. Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.

Exclusion Criteria:

1. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
2. Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: follow-up 42 days after dosing
Secondary outcomes:
measure: Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
timeFrame: follow-up 42 days after dosing
measure: Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
timeFrame: at Day 3, 7, 10 and 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Deawoong pharmaceutical
state: Gangnam-gu
Study officials:
References:
Clinical trial NCT05720585: Subjective Memory Complaints' Cognitive Intervention
Official title: Intervention of Mobile Health Application for Older Adults With Subjective Memory Complaints
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Memory Complaint
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be divided into two parts: development of the mobile medical application for older adults with subjective memory decline and the intervention application. Start by developing and optimizing the application based on the rapid prototyping model. Then, in accordance with the framework of designing and evaluating complex intervention measures proposed by the Medical Research Council of the United Kingdom, pre-experiments will be carried out to apply the developed application to the actual intervention process to test the intervention effect, feasibility, and other contents of the application.


Eligibility criteria: Inclusion Criteria:

* Patients with subjective memory complaints by SMCQ for 6 months and above.
* Individuals age over 60 years (depending on the characteristics of the disease, it can be relaxed to 55 years) are included.
* Older adults owning and being able to use smartphones to access the Internet, or whose caregivers can assist in the completion can also be included.
* Older adults who voluntary participate in the study and provide informed consent are also included.

Exclusion Criteria:

* Older adults diagnosed with cognitive or mild cognitive impairment.
* Older adults diagnosed with other neurological disorders ( cerebrovascular disease, encephalitis, brain tumor, brain trauma, epilepsy, Parkinson 's disease, depression, mania, etc. ), metabolic diseases ( anemia, thyroid dysfunction, folic acid and vitamin B12 deficiency, etc. ), carbon monoxide poisoning and cognitive decline caused by general anesthesia
* Older adults with serious medical and surgical diseases who cannot complete the experiment are also excluded.

Primary outcomes:
measure: Subjective Memory Complaint (SMC)
timeFrame: Change from Baseline Subjective Memory Complaint at 1 month
measure: Cognitive Function
timeFrame: Change from Baseline Cognitive function at 1 month
measure: Memory
timeFrame: Change from Baseline Memory at 1 month
measure: The Quality of Life Rating Scale (SF-12)
timeFrame: Change from Baseline Quality of Life at 1 month
Secondary outcomes:
measure: Demographic characteristics
timeFrame: Base line
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01134185: Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
Official title: Evaluation of Pharmacokinetics, Safety and Tolerability of a Single Dose of Prucalopride, in Subjects With Moderate and Severe Hepatic Impairment, in Comparison With Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Two groups of 8 hepatically impaired subjects, one group of 8 matched healthy subjects
Lead sponsor: Movetis
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers. Furthermore the short-term safety and tolerability of a single dose of prucalopride will be assessed.

Detailed description: In this phase I trial two groups of 6 to 8 hepatically impaired subjects will be evaluated. The first group are the moderate hepatic impairment (Grade B) subjects and the second group the severe hepatic impairment (grade C) subjects. Subjects for both groups will be recruited and treated in parallel. After all subjects with hepatic impairment completed the treatment a third group with matching healthy volunteers will be recruited. Eight healthy subjects will be selected matching for age, gender and weight (BMI based).

The subjects will receive a single dose of 2 mg prucalopride in the morning after overnight fasting followed by the consumption of a standard breakfast after 2 hours.

Pharmacokinetic evaluation of blood samples will be done immediately before and at a specific timepoint up to 120h post-dosing. Urine samples will be taken to determine prucalopride.

Adverse events, including serious adverse events, will be reported from signing the Informed Consent until the last visit. Safety blood samples and a urine sample for urinalysis will be taken.

Eligibility criteria: Inclusion Criteria:

* Main inclusion criteria for hepatic impairment subjects:

  * Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to Child-Pugh classification; Hepatic impairment must be stable, both clinically and biochemically;
  * Within the normal range of body height and weight on the basis of the Body Mass Index.
* Main inclusion criteria for healthy subjects:

  * Matching on sex, age and weight(BMI based).

Exclusion Criteria:

* History or suspicion of barbiturate, amphetamine or narcotic abuse; Suspicion of current alcohol abuse;
* Clinical suspicion or laboratory evidence of unstable hepatic impairment or acute liver injury;
* Clinically relevant renal disease as judged by the investigator.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 6 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 6 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
Study officials:
References:
Clinical trial NCT03089385: Use of a Hypertension Tool to Manage Blood Pressure in Hemodialysis
Official title: Development, Validation, and Implementation of a Clinical Decision Tool for Blood Pressure Management in Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Receiving in-centre HD for at least 3 months
* Considered hypertensive based on a median intradialytic blood pressure ≥ 140/90 mmgHG

Exclusion Criteria:

* Are unable to provide informed consent
* Are deemed medically unstable by the primary physician

Primary outcomes:
measure: Blood pressure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Marisa Battistella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106285: Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
Official title: Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colic, Infantile
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 0
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.

Detailed description: Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.

Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.

Eligibility criteria: Inclusion Criteria:

* otherwise healthy infants
* Infantile colic according to Roe IV criteria
* Full term infants
* Birth weight 2500 - 4000g
* Exclusively breast milk or partially breastfed
* Mothers last education degree is Senior high school

Exclusion Criteria

* Clinically suspected allergy
* Consumption of probiotics, antibiotics, PPI
* Failure to thrive

Primary outcomes:
measure: Daily average of crying time with L reuteri vs placebo
timeFrame: day 7
measure: Daily average of crying time with L reuteri vs placebo
timeFrame: Day 14
measure: Daily average of crying time with L reuteri vs placebo
timeFrame: Day 21
measure: Daily average of crying time with L reuteri vs placebo
timeFrame: Day 28
Secondary outcomes:
measure: Number of responder vs non-responders
timeFrame: baseline, day 7, 14, 21, 28
measure: Reduction of daily average crying time
timeFrame: baseline, day 7, 14, 21, 28
measure: Parents perception of colic severity (Diary)
timeFrame: baseline, day 7, 14, 21, 28
measure: Parents/Family quality of life (Diary)
timeFrame: baseline, day 7, 14, 21, 28
measure: Parental satisfactory (Diary)
timeFrame: baseline, day 7, 14, 21, 28
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Badriul Hegar
Study officials:
affiliation: RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
name: Badriul Hegar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864585: A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
Official title: Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infectious Diseases
Keywords: Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 59
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time

Brief summary: The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.

Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.

This study is seeking for patients with:

* sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
* renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.

Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.


Eligibility criteria: Inclusion Criteria:

1. Patients who received Zavicefta for the first time after the launch of Zavicefta
2. Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
3. Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
4. Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Number of Participants with adverse drug reactions (ADRs)
timeFrame: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
Secondary outcomes:
measure: Number of Participants with Clinical Effectiveness
timeFrame: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
measure: Number of Participants with Clinical Effectiveness at the time of Test of Cure
timeFrame: 28 days after the start of the administration
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02653885: Haematologic Predictors and Clinical Outcome in Cardiac Surgery
Official title: Haematologic Predictors and Clinical Outcome in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: cardiac surgery
open heart surgery
hemogram
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac patients needed cardiac surgery

Brief summary: The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* elective, on-pump cardiac surgery

Exclusion Criteria:

* emergent cases
* pediatric cases
* congenital surgery
* heart transplantation

Primary outcomes:
measure: incidence of combined adverse effects
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIM GUCLU, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01758185: Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Official title: Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Inactivated split influenza vaccine
Immunogenicity
Safety
Consistence
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2013-01-01
Enrollment: 3308
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

Detailed description: A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

Eligibility criteria: Inclusion Criteria:

* more than three years in good healthy

Exclusion Criteria:

* current infectious fever or acute disease
* upper respiratory infectious symptom within 6m
* a history of allergy
* laboratory confirmed influenza
* autoimmune disease
* have get influenza vaccine since 2008

Primary outcomes:
measure: Incidence rate of adverse events of the inactivated split influenza vaccine
timeFrame: two years
Secondary outcomes:
measure: Antibody titre of the inactivated split influenza vaccine
timeFrame: two years
Other outcomes:
Locations:
city: Zhangjiakou
country: China
facility: Xinglong County Center for Disease Control and Prevention
state: Hebei
city: Zhangjiakou
country: China
facility: Zhuolu County Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Beijing Chaoyang District Center for Disease Control and Prevention
name: Nianmin Shi, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bai Y, Shi N, Lu Q, Yang L, Wang Z, Li L, Han H, Zheng D, Luo F, Zhang Z, Ai X. Immunological persistence of a seasonal influenza vaccine in people more than 3 years old. Hum Vaccin Immunother. 2015;11(7):1648-53. doi: 10.1080/21645515.2015.1037998.
citation: Li S, Li L, Ai X, Yang L, Bai Y, Wang Z, Han H, Lu Q, Luo F, Zhang Z, Liu C, Xiao J, Shi N. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people. Hum Vaccin Immunother. 2014;10(3):557-65. doi: 10.4161/hv.27329. Epub 2013 Dec 3.