louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01375335: The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
Official title: The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Postoperative
Dobutamine
Inotropes
Stunning
Heart failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.


Eligibility criteria: Inclusion Criteria:

* 18-90 years
* Left ventricular posterior wall =/\>12mm
* Ejection fraction \> 45%
* Sinus rhythm
* Eligible for aortic valve replacement

Exclusion Criteria:

* Need for concomitant cardiac bypass operation.
* Moderate or severe insufficiency of the mitral valve
* Active endocarditis
* Insufficient ultrasound window
* Using B-blockers
* Liver insufficiency
* Patients treated with COMT-inhibitors
* Allergy towards dobutamine
* Pregnancy
* Women of fertile age who do not use relevant anti-conception
* Lacking participant consent

Primary outcomes:
measure: Cardiac output
timeFrame: From 0 to 90 minutes after drug initiation
Secondary outcomes:
measure: Mean pulmonary artery pressure
timeFrame: From 0 to 90 minutes after drug initiation.
measure: Echocardiography
timeFrame: From 0 minutes to 90 minutes after drug initiation
measure: Changes in mixed venous saturation
timeFrame: From 0 minutes to 90 minutes after drug initiation
measure: norepinephrine requirement
timeFrame: From 0 minutes to 90 minutes after drug initiation
measure: Central venous pressure
timeFrame: From 0 minutes to 90 minutes after drug initiation
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Department of Anaesthesia & Intensive Care, Århus University Hospital
Study officials:
affiliation: Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
name: Erik Sloth, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05449535: Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
Official title: Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
Primary purpose: TREATMENT

Brief summary: This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.

Detailed description: This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.

The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).

Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.

Eligibility criteria: Inclusion Criteria:

1. Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
2. Healthy Chinese subjects aged 18-50 years, male or female;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.

Exclusion Criteria:

1. Surgery history within 6 months prior to screening or any surgery schedule during the study;
2. Last visit in previous drug clinical trial within 3 months prior to screening;
3. Acute diseases occur or receive any medication during the screening period;
4. Other conditions unsuitable for the study confirmed by the investigator.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Baseline through 168 days post-dose
Secondary outcomes:
measure: Serum concentrations of JYB1904 and Omalizumab
timeFrame: Baseline through 168 days post-dose
measure: Serum concentrations of total/free IgE
timeFrame: Baseline through 168 days post-dose
measure: Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)
timeFrame: Baseline through 168 days post-dose
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Shulan (Hangzhou) Hospital
state: Zhejiang
Study officials:
affiliation: Shulan (Hangzhou) Hospital
name: Guiling Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145235: Swedish Macrolane Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Augmentation
Keywords: Breast augmentation with Macrolane
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 1300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All clinics treating females with Macrolane in the breast will be asked to participate.

Brief summary: A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.


Eligibility criteria: Inclusion Criteria:

1. Females previously treated with Macrolane VRF in the breasts
2. Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice.
timeFrame: 2010-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dr Per Hedén
Study officials:
References:
Clinical trial NCT02182635: Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase III Long-term Study of Ba253BINEB in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.


Eligibility criteria: Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients with FEV1.0/FVC (Forced vital capacity) of \<= 70% in the screening test and whose symptoms are stable
2. Patients aged \>= 40 years or older
3. Patients must be able to understand the patient information form

Exclusion Criteria:

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
4. Patients with glaucoma
5. Patients who have prostatic hypertrophy
6. Patients with hypersensitivity to anticholinergic drugs
7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
8. Women who are pregnant or who may become pregnant, or nursing women
9. Patients who are judged by the investigator as inappropriate as the subjects of the study

Primary outcomes:
measure: Number of Patients with Adverse Events
timeFrame: Up to 28 weeks
measure: Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
timeFrame: Baseline, up to week 28
measure: Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
timeFrame: Baseline, up to week 28
measure: Number of patients wiht abnormal changes from baseline in laboratory tests
timeFrame: Baseline, up to week 28
Secondary outcomes:
measure: Change from baseline in FEV1 (Forced expiratory volume in one second)
timeFrame: Baseline, up to week 28
measure: Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
timeFrame: Baseline, up to week 28
measure: Physician's global evaluation (overall improvement)
timeFrame: Up to week 28
measure: Patient's impression
timeFrame: Week 28
measure: Physician's global evaluation (final improvement)
timeFrame: Week 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01507935: Colonisation Resistance Study
Official title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Healthy Infants
Keywords: Healthy infants
Infant formula
Prebiotics oligosaccharides
Colonisation Resistance
Gut Microbiota
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2012-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.


Eligibility criteria: Inclusion Criteria:

* Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
* Parents' or guardian's written informed consent

Exclusion Criteria:

* Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
* Significant congenital abnormality that could affect the study results
* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Gastroenteritis in the last two weeks before inclusion

Primary outcomes:
measure: Gut microbiota composition and its metabolic activity
timeFrame: Week 6
Secondary outcomes:
measure: Gastrointestinal symptoms (incidence and severity)
timeFrame: Week 1, Week 3, Week 6, Week 8
measure: Anthropometry
timeFrame: Week 1, Week 3, Week 6, Week 8
measure: Number, type and severity of (serious) adverse events
timeFrame: Week 1, Week 3, Week 6, Week 8
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
affiliation: Chulalongkorn University
name: Sungkom Jongpiputvanich, A/Prof., MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02011035: Evaluating the Clinical Efficacy and Safety of Colflex
Official title: Evaluating the Clinical Efficacy and Safety of Colfelx
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Personal Satisfaction
Keywords: Oral health
Mouth health
Halitosis
Oral bacteria
Sore throat
Colds
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in town

Brief summary: This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.


Eligibility criteria: Inclusion Criteria:

* availability to give written consent
* age 18-60, men and women (who are not pregnant or nursing)
* people in good health
* able to follow protocol
* must be experiencing a sore throat or cold at least once a year

Exclusion Criteria:

* smokers
* liver and kidney disease
* inflammatory bowel disease
* pancreatitis
* gallbladder or biliary disease
* neurolgical/psychological disease
* bleeding disorders
* platelet abnormatilies
* gastrointestinal disorders that could interfere with fat absorption
* serum triglycerides \> 500 mg/dL and/or total cholesterol \> 300 mg/dL
* hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 Hg
* BMI \>30
* consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
* reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
* reported use of experimental medication within 1 month prior to the trial

Primary outcomes:
measure: Frequency and duration of colds/sore throats
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of oral pathogenic bacteria
timeFrame: 30 days
Other outcomes:
measure: Effect on plasma lipid profile and enzyme measurements
timeFrame: 30 days
measure: Measurement of oral halitosis
timeFrame: 30 days
Locations:
city: Winnipeg
country: Canada
facility: RCFFN: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT02122835: Exercise, Heart Failure, and Type 2 Diabetes
Official title: Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Type 2 Diabetes
Keywords: exercise
aerobic exercise
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

Detailed description: The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* ≥50 yr of age
* New York Heart Association class II-III CHF and ejection fraction ≤35%
* receiving optimal medical therapy
* sedentary (≤ 30 min/wk structured physical activity).
* Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).

Exclusion Criteria:

* smoking
* changes in medication ≤6 wk prior to enrollment
* major cardiovascular event or procedure ≤6 wk prior to enrollment
* foot ulcers
* advanced neuropathy
* co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
* fixed rate pacemaker
* type 1 diabetes mellitus

Primary outcomes:
measure: exercise capacity
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: flow-mediated dilation
timeFrame: baseline, 12 weeks
measure: nitrite flux during exercise
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: William Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251935: Down Syndrome and Effects of Foot Muscle Exercise
Official title: Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pes Planus Down Syndrome Patients
Keywords: Down syndrome
foot deformities
muscle hypotonia
pes planus
joint laxity
exercise training
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 47
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Down syndrome (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. Combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with Down syndrome are at risk for foot alignment problems. Pes planus being the most common amongst them and accounts for 91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers have shown interest in addressing this condition for the effective management of DS population. Conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. Hence the present study is to determine the role of foot muscles exercises in Down Syndrome having pes planus since its effects are positively recorded in normal population.


Eligibility criteria: Inclusion Criteria:

* • Clinically diagnosed cases of DS including both male and female.

  * Bilateral flexible pes planus on the basis of Navicular Drop Test.
  * Able to follow instructions and adhere to the exercise program.
  * Ambulating independently.

Exclusion Criteria:

* • Visual or auditory impairment.

  * Lower limb trauma or surgical intervention past six months.

Primary outcomes:
measure: Gross Motor Function
timeFrame: Baseline
measure: Gross Motor Function
timeFrame: 12 weeks
measure: Gross Motor Function
timeFrame: 24 weeks
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: 12 weeks
measure: Balance
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: ACELP (Institute of Child Development)
state: Sindh
Study officials:
References:
Clinical trial NCT02632435: Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.
Official title: A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment OTT 15-06 A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Trastuzumab Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer
Keywords: HER2 positive
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 56
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. The investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices (PORTs).


Eligibility criteria: Inclusion Criteria

* Histologically confirmed primary breast cancer
* Planned to start trastuzumab based neo/adjuvant therapy: FEC-DH or AC-DH, or; dose-dense AC-TH, or docetaxel/cyclophosphamide/trastuzumab or docetaxel/carboplatin/trastuzumab, or weekly paclitaxel with trastuzumab.
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria

• Contraindication to central line placement.

Primary outcomes:
measure: Accrual rates
timeFrame: one year
measure: Patient compliance
timeFrame: One year
Secondary outcomes:
measure: Physician engagement
timeFrame: One year
measure: Rates of events
timeFrame: One year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clemons M, Stober C, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Vandermeer L, Mazzarello S, Awan A, Basulaiman B, Robinson A, Mallick R, Hutton B, Fergusson D. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer. 2020 Oct;28(10):4891-4899. doi: 10.1007/s00520-020-05326-y. Epub 2020 Jan 30.