louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00651547: Symbicort in Asthmatic Children - SEEDLING
Official title: A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Symbicort
budesonide/formoterol
budesonide
formoterol
children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 405
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years


Eligibility criteria: Inclusion Criteria:

* Baseline lung function tests results as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
* Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study

Primary outcomes:
measure: Morning PEF
timeFrame: Daily
Secondary outcomes:
measure: Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
timeFrame: Throughout the treatment period
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_DIRECTOR
References:
Clinical trial NCT00898547: Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107
Official title: Additional Circulating Markers of Angiogenesis and Disease in Mesothelioma Patients Treated on CALGB 30107
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Mesothelioma
Keywords: advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously enrolled on CALGB-30107 diagnosed with malignant mesothelioma.

Brief summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.

Detailed description: OBJECTIVES:

* Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol CALGB-30107.
* Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients.

OUTLINE: Serum samples previously obtained from patients on protocol CALGB-30107 are tested for levels of thrombospondin I serum, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (ELISA).

PROJECTED ACCRUAL: A total of 47 specimens will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of malignant mesothelioma

  * Unresectable disease
* Must have received treatment with vatalanib on protocol CALGB-30107

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Level of biomarkers, including thrombospondin I, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin (high vs low)
timeFrame: baseline
Secondary outcomes:
measure: Effect of biomarker expression level on overall survival
timeFrame: Up to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Robert A. Kratzke, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02194647: Anti-osteoporosis Medication Monitoring and Management Service
Official title: Anti-osteoporosis Medication Monitoring and Management Service
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoporosis
Fracture
Keywords: Osteoporosis
Medication Monitoring
Education
Adherence
Management
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults treated with anti-osteoporosis medicines (AOMs)

Brief summary: BACKGROUND:

One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares.

OBJECTIVES:

To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch.

METHODS:

Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. the investigators plan to enroll 500 patients with 18-month follow up for each.


Eligibility criteria: Inclusion Criteria:

* Age \>=50 and one of the below
* Newly prescribed with AOMs
* Recent change of AOMs
* Poor adherence to AOMs
* Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.

Exclusion Criteria:

* Life expectancy less than 2 years or can't be assessed for communication problems
* patient in our fracture liaison service or other medication clinical trials

Primary outcomes:
measure: medication adherence
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ding-Cheng Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02273947: Food Effect Study With BMS-955176
Official title: An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-10-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

Detailed description: Primary Purpose

Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/\[Height (m)\]2
* Men and women, ages 18 to 50 years, inclusive
* Women must not be of childbearing potential, must not be breastfeeding

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of cardiac disease or clinically significant cardiac arrhythmias
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) for BMS-955176
timeFrame: Up to Day 4 of Period 4
measure: Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
timeFrame: Up to Day 4 of Period 4
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
timeFrame: Up to Day 4 of Period 4
measure: Plasma concentration at 24 hours post-dose (C24) for BMS-955176
timeFrame: Up to Day 4 of Period 4
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Up to 30 days post discontinuation of dosing
Other outcomes:
Locations:
city: Ruddington Fields
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00680147: Human Papillomavirus (HPV) Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers
Official title: HPV Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV
Keywords: HPV
Gardasil
African-American
adolescent
health behavior
sexually transmitted infections
This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.
Lead sponsor: Syracuse University
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 614
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

Detailed description: The HPV vaccine offers hope that the incidence of cervical cancer can be greatly reduced in the U.S. and globally. However, because the vaccine is recommended for children and early adolescents, vaccine awareness and acceptance among parents is critical to insuring vaccine uptake and public health benefit. Although culturally specific concerns may reduce HPV vaccination among African-American youth, research has not addressed this possibility. Accordingly, the proposed study will enroll 300 mothers in a study to identify barriers to HPV vaccination among low-income, African-American teens. Surveys assessing culturally-specific barriers to HPV vaccination acceptance will be administered to both parents and their vaccine-eligible children. Upon completion of the survey, parents with vaccine-eligible daughters will be invited to receive a free HPV vaccination for their child through a local, teen-friendly health clinic. Outcome analyses will focus on identification of predictors of completed vaccinations among girls and barriers to vaccine acceptance among mothers of teenage sons. Our study will provide critically important behavioral outcome data linking barriers to vaccination to subsequent vaccination decisions in a real-world, health care setting.

Eligibility criteria: Inclusion Criteria:

* Females parent or guardian with an African-American daughter or son between the ages of 11 and 17
* African-American adolescents between the ages of 11-17

Primary outcomes:
measure: completed vaccination with Gardasil
timeFrame: 6 months
Secondary outcomes:
measure: assessed cross-sectionally, at time of initial enrollment
timeFrame: assessed at time of baseline assessment
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Center for Health and Behavior, Syracuse University
state: New York
Study officials:
References:
Clinical trial NCT01174147: A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)
Official title: Brazilian Network of Candidemia: a Laboratory-based Surveillance Study on Candida Bloodstream Infections in 10 Medical Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Federal University of São Paulo
First posted: 2010-08-03
Enrollment: 436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients hospitalized in participating medical centers (tertiary care hospitals) in Brazil

Brief summary: This study will evaluate the incidence rate of Candida blood stream infection (candidemia) among people hospitalized in participating medical centers in Brazil, and will assess the antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be tested in the study. Candida blood stream isolates collected from people hospitalized for any reason during the study period will be sent to a core mycology laboratory for antifungal drug susceptibility testing. All people who develop candidemia while hospitalized will be considered participants in the study.


Eligibility criteria: Inclusion Criteria:

* Hospitalized in a participating medical center
* Developed candidemia blood stream infection (confirmed by isolation of Candida species from blood culture)

Primary outcomes:
measure: Number of participants with Candidemia per 1000 hospital admissions
timeFrame: Approximately 1 year
measure: Number of participants with Candidemia per 1000 patient-Days in hospital
timeFrame: Approximately 1 year
measure: Percentage of Specific Candida Isolates Susceptible to Amphotericin B, Fluconazole, Voriconazole, Anidulafungin, and Caspofungin
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04209647: A Comparison of Continuous Moderate Training and Reduced High Intensity Interval Training in Obese Young Adults
Official title: A Comparison of Reduced HIIT and Moderate Intensity Continuous Exercise in Obese Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Exercise
Oxygen Consumption
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Reduced-exertion high-intensity interval training (REHIT) is a alternative method to continuous exercise programs. The investigators aimed comparing metabolic effects of REHIT and continuous exercise in young adults, in this study.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-22,
* BMI ≥ 30,
* Female gender,

Exclusion Criteria:

* Smoking history,
* Having any metabolic disease except obesity,

Primary outcomes:
measure: Aerobic Capacity
timeFrame: 1 year
Secondary outcomes:
measure: Total Exercise Duration
timeFrame: 1 year
Other outcomes:
measure: Body Fat Percentage
timeFrame: 1 year
Locations:
city: Istanbul
country: Turkey
facility: Istınye University
Study officials:
affiliation: Istinye University
name: Nurgul Durustkan Elbasi, PhD
role: STUDY_CHAIR
affiliation: Istinye University
name: Yunus Emre Tutuneken, PT
role: STUDY_CHAIR
affiliation: Istınye U
name: Yasemin Cirak, Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health science
name: Duygu Korkem, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Beyza Karaduz, MsC
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02244047: Cytokine Profile in Children With Celiac Disease
Official title: Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Celiac Disease
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2014-09-18
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies.

Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory.

Hypothesis

1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls.
2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase.

In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups:

1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.
2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.
3. Group: 20 healthy children


Eligibility criteria: Inclusion Criteria:

* celiac disease on gluten free diet

Exclusion Criteria:

* acute or chronic diseases,
* permanent use of medication and
* ingestion of antibiotics at least one month prior to study

Primary outcomes:
measure: Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Maribor
name: Martina Klemenak, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klemenak M, Dolinsek J, Langerholc T, Di Gioia D, Micetic-Turk D. Administration of Bifidobacterium breve Decreases the Production of TNF-alpha in Children with Celiac Disease. Dig Dis Sci. 2015 Nov;60(11):3386-92. doi: 10.1007/s10620-015-3769-7. Epub 2015 Jul 2.
Clinical trial NCT01460147: Osteoporosis and MRI Study in Hemophilia
Official title: Bone and Joint Health in an Adult Hemophilia Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Mineral Density
Hemophilia A
Hemophilia B
Keywords: Hemophilia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 3
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic means: dual-energy X-ray absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers. In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI substudy). No investigational product will be dispensed.


Eligibility criteria: Inclusion Criteria:

* Male and at least 25 years old at the time of screening
* Moderately severe or severe hemophilia A or B (factor VIII or factor IX \<= 2% by chart documentation)
* Ambulatory (ie, not wheel chair dependent)
* Performance status - ECOG of 0 or 1 (= out of bed at least 75% of time)
* Willing and able to comply with the requirements of the protocol and is able to give informed consent

Additional inclusion criteria for MRI Substudy:

* Baseline knee joint space width is \>= 3mm at the medial or lateral aspect of either knee as measured by weightbearing fixed flexion PA X-ray
* Able to undergo 1.5 or 3T MRI

Exclusion Criteria:

* Inability to position properly for DXA
* Presence of orthopedic hardware or other artifact in the lumbar spine (L1-L4) or either proximal femur
* Prior documentation of being HIV positive
* Radiosynovectomy or surgical synovectomy within the last 6 months
* Current or past treatment with bone active drugs
* Long-term corticosteroid use \[defined as 7.5-mg prednisone daily (or equivalent) for \>= 3 months\]
* If subject is family member or employee of the investigator

Additional exclusion criteria for MRI Substudy:

* Any contraindication or relative contraindication to MRI
* Less than 3mm knee joint space width at the medial and lateral aspect of both knees on baseline X-ray evaluation
* Knee bleed within 30 days of informed consent
* Prior total knee arthroplasty (TKA)

Primary outcomes:
measure: Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline
timeFrame: Baseline
measure: Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years
timeFrame: 2 years
measure: Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Orthopedic Hospital
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: