louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00308191: A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
Official title: A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
Formoterol
Tiotropium
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 128
Sex: ALL
Minimum age (years): 40
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 safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.


Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria:

* Medical diagnosis of asthma
* Significant condition or disease other than COPD

Primary outcomes:
measure: Measure of lung Function
Secondary outcomes:
measure: Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sepulveda
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Tamarac
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Livonia
country: United States
facility: Research Site
state: Michigan
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Liverpool
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Collegeville
country: United States
facility: Research Site
state: Pennsylvania
city: El Paso
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
References:
citation: Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008 Apr;102(4):479-87. doi: 10.1016/j.rmed.2007.12.019. Epub 2008 Feb 6.
Clinical trial NCT06353191: Biomarkers to Predict Cancer Therapy-related Cardiotoxicity
Official title: Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy

Brief summary: This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.

Detailed description: PRIMARY OBJECTIVE:

I. To collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (CRCT) and 2) patients who are at a high risk for developing CRCT.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
* One of the following:

  * Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment
  * Completed chemotherapy with no cardiotoxicity at least two years post treatment
  * Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity
* An understanding of the protocol and its requirements, risks, and discomforts
* The ability and willingness to sign an informed consent

Exclusion Criteria:

- Inability on the part of the patient to understand the informed consent or be compliant with the protocol

Primary outcomes:
measure: Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nadine Norton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04054791: Endonasal Dacryocystorhinostomy and Evolution of the Stoma Size
Official title: Endonasal Dacryocystorhinostomy: Prospective Study of the Evolution of the Stoma Size
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endonasal Dacryocystorhinostomy
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had chronic epiphora or chronic dacryocystitis.

Brief summary: Dacryocystorhinostomy (DCR) is a procedure of choice for nasolacrimal duct obstruction. Endonasal procedures for DCR were described as early as 1893 by Caldwell. However, external DCR was practiced more commonly because of better visualization of anatomic features. The miniaturization of surgical instruments and close partnership between ophthalmologist and otorhinolaryngologist had led to a renewal of endonasal approach.

The main objective of the study is to show the evolution of stoma size after endonasal DCR and validate the direct measurement of mucous orifice. It will also allow determining if the stoma evolution size may be a predictive factor for operational effectiveness.


Eligibility criteria: Inclusion Criteria:

* Patient with chronic epiphora or chronic dacryocystitis

Exclusion Criteria:

-

Primary outcomes:
measure: Evolution of the stoma size
timeFrame: Month 12
Secondary outcomes:
measure: Mucous orifices size
timeFrame: Month 2
measure: Ratio of patients for whom the operation is a success
timeFrame: Month 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01346891: Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
Official title: Polymorphisms of the Thiazide's Receptor Gene SLC12A3 and Development of Hyponatremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thiazide Diuretics Induced Hyponatremia
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Sociedad Argentina de Hipertension Arterial (SAHA)
First posted: 2011-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 21 years old that require treatment with thiazide diuretics

Brief summary: The purpose of this study is to detect if there are any differences in the coding region of SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and those thiazides consumers without hyponatremia that have demonstrated good tolerance to the drug.

Detailed description: This is a Case Control study to compare the coding region of SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and those thiazides consumers without hyponatremia that have demonstrated good tolerance to the drug.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 21 years, belonging to one of the following groups:

   1. Patients who have had Thiazide induced hyponatremia with serum sodium lower than 125 meq/L included in the Institutional Registry of Hyponatremia (Cases)
   2. Patients with good tolerance to chronic treatment with Thiazides tha never had associated hyponatremia (Controls)
2. Patients with normal serum sodium measurements before the start of the Thiazides

Exclusion Criteria:

1. Refusal to participate or to the informed consent process
2. Unclear cause of hyponatremia, or other hyponatremia cause concomitant to Thiazide diuretics
3. Patients related to other individuals already included in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04358991: Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF
Official title: Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving Continuous Venovenous Hemodiafiltration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2020-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with confirmed or presumed invasive bacterial infections

Brief summary: Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

Detailed description: Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.

Eligibility criteria: Inclusion Criteria:

* Adult patients receiving ceftazidime-avibactam as standard care

Exclusion Criteria:

* Less than 18 years-old

Primary outcomes:
measure: Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ryan Shields, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407391: Antecedent Picky Eating Behaviour in Young Children
Official title: Antecedents of Picky Eating Behaviour in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Behavior
Child Rearing
Eating Behavior
Parent-Child Relations
Parenting
Feeding and Eating Disorders of Childhood
Keywords: Picky eater
Fussy eater
Faddy eater
Nutrition
Lead sponsor: University of Bristol
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
name: Wellcome Trust
name: Medical Research Council
First posted: 2018-01-23
Enrollment: 6608
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women in the former Avon Health Authority with an expected delivery date between April 1991 and December 1992 were eligible for the study; 14,541 pregnant women were initially enrolled, resulting in a cohort of 14,062 live births with 13,988 alive at 1 year of age. Parents/caregivers were sent a questionnaire when the child was 3 years old that included a question on picky eating behaviour. Singleton children whose parents/caregivers answered this question were included in the study.

Brief summary: Picky eating behaviour in young children is a very common concern for parents. The aim of the study is to investigate factors during early life which are associated with a child becoming a picky eater.

Detailed description: Singleton children from the Avon Longitudinal Study of Parents and Children will be studied prospectively (n=5758-6608). Parental-completion questionnaires will be used to define 'picky eating' status at age 3 years, and child and parental feeding behaviours and practices throughout the first 2 years of the child's life. Multinomial logistic regression models with 3 levels of picky eating status (not, somewhat and very picky) as the dependant variables will be used to test associations with antecedent variables, first assessing variables from pregnancy, and the first and second year of life, separately, then combining all significant variables in a final model.

Eligibility criteria: Inclusion Criteria:

* Child enrolled in ALSPAC, singleton, parent answered question on picky eating behaviour in questionnaire

Exclusion Criteria:

* Child not enrolled in ALSPAC, multiple, parent did not answer question on picky eating behaviour in questionnaire

Primary outcomes:
measure: Being a very picky eater or not at age 3 years
timeFrame: Age 3 years
Secondary outcomes:
measure: Being a somewhat picky eater at age 3 years
timeFrame: Age 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Bristol
name: Nic Timpson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02753491: The Effect of Motivational Short Interview Model in Type 2 Diabetic Patient in Primary Care in TURKEY
Official title: The Effect of Motivational Short Interview Model in Type 2 Diabetic Paitent in Primary Care in TURKEY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle-related Condition
Keywords: short interview, diabetes, lifestyle changes, primary care
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 163
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study designed for primary care practionars for chronic care in primary care. A new model of motivational short interview used for intervention. The aim of this study is to develop diet and exercise regimens in type 2 diabetic patients.

Detailed description: This is a randomized controlled trial. The pedometer for one week has given to and filling one day food intake form asked from all participants. The weights and the heights of the participants were measured and the Beck depression scale for primary care, the modify Moresby scale, the EQ5D, the MDDQ and the motivation scale filled face to face with all participants. In intervention group the steps of the motivational short interview model were; increase patient awareness about his/her type 2 diabetes and its difficulties, then discuss alternative solutions for the problems the participant has and making decisions for action, and the third and fourth interview includes new alternative solutions for new difficulties if there is and promotion of self efficacy.

Eligibility criteria: Inclusion Criteria:

* Being type 2 diabetic unless for one year
* No drug changes for last three months
* HbA1c levels between 7-10%
* BMI \>25 kg/m2
* At least %80 compliance with medical treatment
* no depression

Exclusion Criteria:

* Getting \>7 point from beck depression scale for primary care
* Using anti depressed treatment

Primary outcomes:
measure: increasing pedometer levels +1300 step
timeFrame: 3 months
measure: decreasing 300 cal daily food intake
timeFrame: 3 months
Secondary outcomes:
measure: increasing short EPAQ category to 2 from 1.
timeFrame: 3 months
measure: loosing weight
timeFrame: 3 months
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
affiliation: Marmara University
name: Mehmet AKMAN, Asis. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05744791: Active Play Intervention for Preschoolers
Official title: The Influence of a Planned Movement and Physical Activity Program on the Physiological and Psychology Parameters in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: Preschoolers
Active Play
Teacher guided interventions
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two preschools. One will be randomized to the intervention and one to the control group.
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine

\* What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5 years?

Researchers will compare a planned movement program to a control group, where current instruction is implemented.

Detailed description: A majority of preschool children do not participate in the recommended levels of physical activity and are deficient in fundamental motor skills. These deficits may also impact body composition. Preschool teachers serve as the gateway to providing physical activity opportunities at preschool but many fail to do so. As play is developmentally appropriate for preschools and part of many curriculums adding active elements to play may be a feasible solution for teachers to implement physical activity opportunities. This project will evaluate the effect of a planned movement program that incorporates elements of active play on preschoolers' body composition, physical activity, time on task, and fundamental motor skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the school year with a wrist-worn wearable accelerometer. Body composition will be assessed with a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by observing children in their classroom. The outcomes of this study will be used to implement sustainable physical activity programming for preschoolers.

Eligibility criteria: Inclusion Criteria:

* 3 to 5 years of age
* attending one of the preschools 5 days a week.

Exclusion Criteria:

* less than 3 years of age
* greater than 5 years of age at the beginning of the study
* attends the preschool 2 days or 3 days a week

Primary outcomes:
measure: Physical Activity
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Fundamental motor skills
timeFrame: 12 weeks
measure: Time on Task
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
References:
Clinical trial NCT05813691: Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.
Official title: Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Hepatitis C
Hepatitis
Keywords: hepatitis C virus
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 4000
Sex: ALL
Minimum age (years): 54
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli

Brief summary: The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy.

The main questions it aims to answer are:

what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up?

Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.


Eligibility criteria: Inclusion Criteria:

* Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli

Exclusion Criteria:

* Patients born after january 1st 1968
* Known infection of hepatitis C virus
* Previous treatment against hepatitis C virus

Primary outcomes:
measure: prevalence of antibodies against hepatitis C virus in cohort population
timeFrame: 24 months
Secondary outcomes:
measure: Characteristics of population
timeFrame: 24 months
measure: Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic
timeFrame: 24 months
measure: Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: