louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00650026: Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
Official title: Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-04-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis


Eligibility criteria: Inclusion Criteria:

* Eighteen years or older
* Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
* Females - negative pregnancy test at screening
* Confirmed diagnosis of active RA \>= 6 swollen joints and \>= 9 tender joints
* Met ACR criteria for diagnosis of RA for at least 3 months
* Active RA defined by a DAS \>= 3.2 at study entry

Exclusion Criteria:

* Subject had prior treatment with cyclophosphamide or chlorambucil
* Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
* Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
* Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03135626: Comparison of The Success Rates of Four Different Pulpotomy Techniques
Official title: Comparison of The Success Rates of Four Different Pulpotomy Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Extensive Decay in Primary Molars
Keywords: Pulpotomy
Primary molars
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth study design was used
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.


Eligibility criteria: Inclusion Criteria:

* Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

Exclusion Criteria:

* The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

Primary outcomes:
measure: Total success rate
timeFrame: 6 months after pulpotomy treatment
measure: Total success rate
timeFrame: 12 months after pulpotomy treatment
measure: Total success rate
timeFrame: 24 months after pulpotomy treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Yeliz Guven, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688726: Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Official title: Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lipid Deficiency
Keywords: Dry eye
Ocular surface
Vision complaint
Tear film stability
Time controlled functional visual acuity
Tear film kinetics
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 91
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 evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.


Eligibility criteria: Inclusion Criteria:

* Non-contact lens wearer;
* Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
* Lipid deficiency;
* Best visual acuity of 6/9 or better in each eye;
* Willingness to adhere to the instructions set in the clinical protocol;
* Signature of the subject informed consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of systemic medication which might produce dry eye side effects;
* Systemic disease which might produce dry eye side effects;
* Active or recent ocular inflammation or infection;
* Use of ocular medication;
* Significant ocular anomaly;
* Previous ocular surgery;
* Previous use of Restasis;
* Any medical condition that might be prejudicial to the study;
* Pregnant or lactating;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Bulbar Conjunctival Staining
timeFrame: Month 1
Secondary outcomes:
measure: High Contrast logMAR Time Controlled Visual Acuity (TCVA)
timeFrame: Month 1
measure: Non Invasive Tear Film Break-up-time (NIBUT)
timeFrame: Month 1
Other outcomes:
Locations:
Study officials:
affiliation: OTG Research & Consultancy
name: Michel Guillon, PhD, FCOptom, FAAO, CCTI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956826: Continuous Fetal Monitoring During Vacuum Delivery
Official title: Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Vacuum Delivery
Keywords: electrode vacuum delivery
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.

Detailed description: The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. The electrode is a standard one inserted in the vacuum device.

Eligibility criteria: Inclusion Criteria:

* All fetuses at vacuum delivery

Exclusion Criteria:

* None

Primary outcomes:
measure: Quality of fetal heart rate monitoring in both arms
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem
Study officials:
affiliation: Hadassah
name: David Mankuta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01955226: CHG Dressings in Children With Central Lines
Official title: Unit Based Comparison of Non- Versus Chlorhexidine-Impregnated Central Line Dressings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Children With Central Venous Access
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the number of unscheduled central catheter dressing changes compared to standard clear Tegaderm IV dressing in pediatric patients between the ages of 2 months to 18 years with central venous access. Secondarily, we will monitor contact skin irritation and central line associated blood stream infections.

Detailed description: In this prospective, randomized, cohort study, we plan on enrolling all patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for \> 48 hours. Patients will be randomized to either receive 1) Tegaderm CHG clear dressing or 2) standard clear Tegaderm IV dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* All patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for \> 48 hours.

Exclusion Criteria:

* Patients with known allergies to chlorhexidine or Tegaderm and those previously enrolled in this study will be excluded.
* Patients with portacatheters

Primary outcomes:
measure: Reduction in unscheduled central catheter dressing changes
timeFrame: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
Secondary outcomes:
measure: Blood Stream Infection
timeFrame: Discharge (at 2 weeks or more)
measure: Skin irritation
timeFrame: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: John S Giuliano Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235326: Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
Official title: Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: residents of Walkerton ontario at outbreak
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 4561
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of walkerton

Brief summary: Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS) remains poorly understood. This could allow material in the bowel to reach deeper tissues of the bowel wall leading to inflammation and changes in muscle and nerve function. This is also early evidence that genetic programming of people with PI-IBS prevents them from turning off inflammation once it begins. Literature suggests that IBS may develop at greater rates in individuals with pro-inflammatory genotype and that these individuals may be at increased risk of inflammatory bowel diseases (IBD).

Detailed description: This research will study chronic gastrointestinal problems in the residents of Walkerton, Ontario region. Determine whether acute bacterial infection is a risk factor for development of inflammatory bowel disease using the population of Walkerton as a cohort. We hypothesize that exposure to bacterial infection leads to development of post infectious irritable bowel syndrome which is associated with an increase in intestinal permeability and immune activation with low grade intestinal inflammation and that this sequence of events will trigger inflammatory bowel disease in genetically susceptible individuals

Eligibility criteria: Inclusion Criteria:

* Participants must be residents of the Walkerton, Ontario region at the time of Outbreak who consented to the study

Exclusion Criteria:

* Non residents of Walkerton Ontario at the time of outbreak

Primary outcomes:
measure: Number of Participants With Post Infectious Irritable Bowel Syndrome
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Walkerton
country: Canada
facility: Walkerton
state: Ontario
Study officials:
affiliation: McMaster University
name: John k Marshall, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04650126: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
Official title: A Phase I, Randomized, Double-blind, Parallel Group and Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab in Response to Single Ascending Intravenous Infusion Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Baliopharm Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* healthy male subjects
* body mass index 18-32 kg/m2
* normal physical examination, clinical laboratory values and ECG
* additional inclusion criteria apply

Exclusion Criteria:

* febrile or infectious illness at least 7 days prior to the first administration
* any active physical disease, acute or chronic
* history of alcohol or drug abuse
* history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
* additional exclusion criteria apply

Primary outcomes:
measure: pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
timeFrame: 8 days
measure: PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
timeFrame: 8 days
measure: PK: Maximum Plasma Concentration [Cmax]
timeFrame: 8 days
measure: PK: Terminal half life (t1/2)
timeFrame: 8 days
measure: PK: Apparent terminal elimination rate constant (λz)
timeFrame: 8 days
measure: PK: Mean residence time (MRT)
timeFrame: 8 days
measure: PK: Clearance (CL)
timeFrame: 8 days
measure: PK: Apparent volume of distribution (Vz)
timeFrame: 8 days
measure: Any adverse event, serious adverse event (SAE)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm
state: Brisbane
Study officials:
affiliation: Q-Pharm Pty Limited
name: Kristi McLendon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242826: Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects
Official title: A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
* Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
* A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry)
* Not able or willing to refrain from smoking during the inpatient period

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve from 0 to 24hours
timeFrame: 24 hours profile after single dose of trial drug
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve between different time intervals
timeFrame: 24 hours profile after single dose of trial drug
measure: Maximum observed serum insulin aspart concentration
timeFrame: 24 hours profile after single dose of trial drug
measure: Number of adverse events.
timeFrame: After 3-10 days of treatment
measure: Number of hypoglycaemic events
timeFrame: After 3-10 days of treatment
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01890226: A Mobile Personal Health Record for Behavioral Health Homes
Official title: A Mobile Personal Health Record for Behavioral Health Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hyperlipidemia
Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-07-01
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.

This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.


Eligibility criteria: Inclusion Criteria:

* one or more of the following conditions: hyperlipidemia, hypertension, diabetes
* able to give consent
* patient in the behavioral health home

Exclusion Criteria:

* Unable to give consent

Primary outcomes:
measure: Change in Composite Quality Score
timeFrame: Baseline, 12 month post intervention
Secondary outcomes:
measure: Change in Patient Assessment of Chronic Illness Care
timeFrame: Baseline, 6 month post intervention, 12 month post intervention
measure: Change in Patient Activation Measure
timeFrame: Baseline, 6 month post intervention, 12 month post intervention
measure: Change in Health-related Quality of Life
timeFrame: Baseline, 6 month post intervention, 12 month post intervention
Other outcomes:
Locations:
city: Conyers
country: United States
facility: Viewpoint Health & Oakhurst Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Benjamin Druss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Druss BG, Li J, Tapscott S, Lally CA. Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes. Psychiatr Serv. 2020 Aug 1;71(8):803-809. doi: 10.1176/appi.ps.201900381. Epub 2020 May 4.