louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04634708: The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
Official title: The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiomyopathies
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Keywords: EXCOR Ventricular Assist Device
EXCOR Active
Mobilization
Pediatric
Lead sponsor: Berlin Heart GmbH
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 24
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.

Brief summary: The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.

Detailed description: The study has a prospective, multicenter, international, single arm, observational design.

Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system,
* Age \< 18 years,
* Patient and legal guardian has consented via signature on the study informed consent form,
* Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator.

Exclusion Criteria:

* Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system,
* Patient and/or legal representative has not given written consent to participate in the study (non-consent),
* Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.

Primary outcomes:
measure: EXCOR Active device performance
timeFrame: 52 days
Secondary outcomes:
measure: Successful patient outcome rates
timeFrame: Whenever it happens or 52 days
Other outcomes:
measure: Safety of the device
timeFrame: 52 days
measure: Mobility
timeFrame: 52 days
measure: Quality of Life of the Patient and Family
timeFrame: 52 days
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
References:
Clinical trial NCT06524908: Study on the Effectiveness of a School-Based Fat Loss Program for Adolescents
Official title: Study of the Effectiveness of an Exercise Intervention Oriented Toward Fat Loss in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Lead sponsor: Aiyoudong Children and Youth Sports Health Research Institute
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The students were divided into an intervention group and a control group. The intervention group attended fat loss exercise classes three times a week and the parents cooperated with us in dietary monitoring and control. Before and after the intervention, questionnaires were completed, physical fitness and body composition were measured, and physical activity measurement bracelets were worn for 4 days. In this study, it is possible to know the mental health state, physical activity habits, body composition and physical fitness of adolescents.


Eligibility criteria: Inclusion Criteria:

* Passed PAR-Q questionnaire screening
* No professional sports experience
* Able to understand the test
* Voluntarily participate in the entire testing process

Exclusion Criteria:

* Serious organic pathology of the heart, brain, lungs, kidneys, and locomotor system
* Taking medication for a chronic condition
* Have history of psychiatric disorders
* Inability to complete follow-up visits or poor adherence.

Primary outcomes:
measure: Body fat percentage (%)
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Physical fitness
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Physical activity
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Fat-free mass
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Fat mass
timeFrame: From enrollment to the end of intervention at 12 weeks
Secondary outcomes:
measure: Salivary testosterone
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Resilience
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Self-esteem
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Aggression
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Eating Self-efficacy
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Exercise Self-Efficacy
timeFrame: From enrollment to the end of intervention at 12 weeks
Other outcomes:
Locations:
city: Weifang
country: China
facility: Aiyoudong Children and Youth Sports Health Research Institute
state: Shandong
Study officials:
References:
Clinical trial NCT02656108: Omission of Controlled Cord Traction During Active Management of Third Stage of Labor
Official title: Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Stage, Third
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

Detailed description: 300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* term pregnancy

Exclusion Criteria:

* episiotomy
* operative vaginal delivery
* known coagulation defect
* Acute complication during labor e.g. eclampsia

Primary outcomes:
measure: sever post partum haemorrhage
timeFrame: 24 hours
Secondary outcomes:
measure: duration of third stage of labor
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Ahmed M kotb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213408: Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
Official title: Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Flutter
Keywords: Arrhythmia
atrial flutter
catheter ablation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 120
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: Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.


Eligibility criteria: Inclusion Criteria:

* first episode of symptomatic typical atrial flutter
* \> 18 years old

Exclusion Criteria:

* Prior antiarrhythmic drug treatment for atrial flutter
* History of cavotricuspid isthmus ablation
* Pregnancy
* Hyperthyroidism
* contraindication for anticoagulant therapy
* Life expectancy \< 1 year
* contraindication to catheter ablation or to electrical cardioversion

Primary outcomes:
measure: Absence of typical atrial flutter recurrence at 6 and 12 months
Secondary outcomes:
measure: Cost/effectiveness ratio at 12 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen
state: Seine Maritime
Study officials:
affiliation: Service de Cardiologie, Rouen University Hospital
name: frederic Anselme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05923008: A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 182
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 is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.


Eligibility criteria: Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function

Exclusion Criteria:

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 30 days post last dose
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: Time from first dose to best response to treatment, assessed up to 3 years
measure: duration of response(DoR)
timeFrame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years
measure: overall survival (OS)
timeFrame: Time from first dose to death, assessed up to 3 years
Other outcomes:
Locations:
city: Birtinya
country: Australia
facility: Sunshine Coast University
state: Queensland
Study officials:
References:
Clinical trial NCT05107908: Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Official title: Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: Eating
Overweight
Obesity
Food
Weight Loss
Magnetic Resonance Imaging
Neuroimaging
Brain
Body Weight
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-11-04
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine how different behavioral interventions designed to alter food perceptions and behaviors affect brain responses to food, eating behaviors, and body weight.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* BMI of 27 or greater

Exclusion Criteria:

* MRI contraindications (e.g., metal or electronic devices in the body)
* Pregnancy

Primary outcomes:
measure: Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging
timeFrame: Baseline, 12 weeks
measure: Change in Food Image Ratings
timeFrame: Baseline, 12 weeks
measure: Change in Food Intake
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Percent Change in Body Weight
timeFrame: Baseline, 12 weeks
measure: Change in Fat Mass
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Tregellas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00604708: Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Official title: Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* History of clinical manifestation of any flavivirus infection
* History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 4 weeks prior to enrollment
* Infection with HIV, Hepatitis B or Hepatitis C
* Pregnancy, lactation or unreliable contraception in female subjects

Primary outcomes:
measure: SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
timeFrame: Day 56
measure: GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
timeFrame: Day 56
Secondary outcomes:
measure: Safety and Adverse Events
timeFrame: until Day 56
measure: Immunogenicity at Day 28
timeFrame: Day 28
measure: Immunogenicity at Day 56 for North America vs. Europe
timeFrame: Day 56
measure: Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
timeFrame: Day 56
Other outcomes:
Locations:
Study officials:
affiliation: Valneva Austria GmbH
name: Astrid Kaltenboeck, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01392508: IMproved PREdiction of Severe Sepsis in the Emergency Department
Official title: Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein (HBP) Assay for Indicating the Presence, or Outcome, of Severe Sepsis (Including Septic Shock), Over 72 Hours, in Patients With Suspected Infection Following Emergency Department Admission.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock
Lead sponsor: Axis Shield Diagnostics Ltd
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to emergency department with suspected infection

Brief summary: The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years
* Suspected Infection
* one or more SIRS criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Linkoping
country: Sweden
facility: Universitetssjukhuset i Linkoping
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus i Lund
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhuset i Malmo
city: Orebro
country: Sweden
facility: Universitetssjukhuset i Orebro
Study officials:
affiliation: Skanes Universitetssjukhus I Lund, Sweden
name: Adam Linder
role: PRINCIPAL_INVESTIGATOR
affiliation: Skanes universitetssjukhuset i Malmo
name: Magnus Paulsson
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitetssjukhuset i Linkoping
name: Patrik Nyberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitetssjukhuset i Orebro
name: Anna Lange-Jendeberg
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Health System
name: Ryan Arnold
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linder A, Arnold R, Boyd JH, Zindovic M, Zindovic I, Lange A, Paulsson M, Nyberg P, Russell JA, Pritchard D, Christensson B, Akesson P. Heparin-Binding Protein Measurement Improves the Prediction of Severe Infection With Organ Dysfunction in the Emergency Department. Crit Care Med. 2015 Nov;43(11):2378-86. doi: 10.1097/CCM.0000000000001265.
Clinical trial NCT01838408: Evaluation of Proposed EZ2go Complete Bowel Cleansing System
Official title: Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Colonoscopy
Surveillance Colonoscopy
Colonoscopy
Keywords: screening colonoscopy
surveillance colonoscopy
colonoscopy
Lead sponsor: Borland-Groover Clinic
Sponsor class: OTHER
Collaborators: name: Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.
First posted: 2013-04-24
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).

To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.


Eligibility criteria: Inclusion Criteria:

* Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
* Male and Female participants 18 years of age and older.
* Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
* Negative urine test at the screening visit.
* Subject is able to read and understand the informed consent form and signs the informed consent form.

Exclusion Criteria:

* Contraindication to any of the bowel preparations being used in the study.
* Unable/unwilling to fill out patient questionnaires following procedure.
* Pregnant or lactating.
* Unwilling to perform indicated lab work.
* Lab results that would indicate stage 4-5 chronic kidney disease (GFR \<30MI/min1.73 m2).
* Personal history of colorectal cancer.
* Personal history of colorectal or small bowel surgery.
* Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.

Primary outcomes:
measure: Measurement of Efficacy
timeFrame: 24 hours
Secondary outcomes:
measure: Evaluate the safety
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
Study officials:
References: