louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00409409: Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Official title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Sublingual immunotherapy
Grass pollen tablet
Allergic rhinoconjunctivitis
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 278
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients aged 5 to 17 years.
* Written consent / assent.
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
* Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
* Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

* Patients who have received any desensitisation treatment for grass pollen.

Primary outcomes:
measure: Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
timeFrame: Pollen period (average of 38.6 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Campus Virchow Klinikum
Study officials:
affiliation: Charité - Campus Virchow Klinikum, Berlin, Germany
name: Ulrich Wahn, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.
Clinical trial NCT03672409: Diabetes Training Program for Health Professionals From Hermosillo, Sonora
Official title: Diabetes Training Program for Doctors, Nurses and Nutritionists in Primary Health Care in Hermosillo, Sonora
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knowledge
Keywords: Knowledge in Type 2 diabetes,
Training program
Primary health care
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Primary health care is the medical assistance available to all individuals in a community and is considered the core of the health system. Diabetes, among other chronic diseases, is a common reason for medical consultation in primary health care. Worldwide and in Mexico, the prevalence of diabetes has been increasing in recent decades, which also leads to an increase in the number of deaths. On the other hand, the annual cost of medical care for diabetes in the country has increased due to the exacerbation of complications and comorbidities associated, which are presented, among other causes, by a deficiency of knowledge in the diagnosis, evaluation, management and follow-up of type 2 diabetes, of health professionals (doctors, nurses, nutritionists) working in primary health care.

The present study will allow evaluating the effect of a training program, is a single-cohort clinical study with pre- and post-intervention measurements lasting 6 weeks, including the initial and final measurements of health professionals currently working in primary health care of Hermosillo Sonora.

Detailed description: The study aims to improve knowledge in diabetes through the design and evaluation of a training program in health professionals (doctors, nurses and nutritionists) in primary health care.

The hypothesis of the study is that the training program in diabetes aimed doctors, nurses and nutritionists in primary health care will significantly increase knowledge in diabetes.

Eligibility criteria: Inclusion Criteria:

* Physicians, nurses and nutritionists of primary health care in Hermosillo, Sonora.
* Belonging to the health jurisdiction and the general hospital of the state
* That provide consultation to patients with diabetes
* Age 20 years and less than 65
* Desire of participate
* Sign up the consent form

Exclusion Criteria:

* Do not meet the inclusion criteria

Primary outcomes:
measure: Change in knowledge measurements in diabetes by questionnaire
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Investigación en Alimentación y Desarrollo
state: Sonora
Study officials:
affiliation: Centro de Investigación en Alimentación y Desarrollo A.C.
name: Julian G Esparza Romero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00525109: Elevated Serum HDL in Four Generations of a Nashville Family
Official title: Elevated Serum HDL in Four Generations of a Nashville Family
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperlipidemias
Keywords: Cholesterol
Hyperlipidemia
Gene array
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family

Brief summary: The purpose of this study is to determine the genetic basis of one family's hereditary hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.

Detailed description: HDL, or good cholesterol, has been shown to protect against heart attack and stroke. How HDL works as a protective agent is not well understood. There is a family that has 4 generations of living members with high HDL level. In the study, after consent is obtained, we will obtain 2 tablespoons of blood from all the family members in order to study their cholesterol levels and to obtain DNA in order to determine if there is a pattern of inheritance for this trait. We will also have them fill out a questionnaire about their medical history, diet and activity level as all of these can affect their HDL levels. In addition we will obtain additional blood (about 2 tablespoons) for plasma, white blood cells and also perform a biopsy to obtain skin cells from a matched pair of family members with and without the trait in order to determine which genes might be turned on and off because of this trait. We also wish to study other families who have members with high HDL cholesterol as well. These individuals will be identified from a core database.

Eligibility criteria: Inclusion Criteria:

* 26 living members of a family with HDL levels greater than 90mg/dl and several of whom will act as related age matched controls.
* The investigators will also identify individuals in a lipid core database with HDL's of greater than 90mg/dl who have normal or low LDL and triglyceride levels and determine if they have normal or low LDL and triglyceride levels and determine if they have family members (parents or siblings) who also have high HDL cholesterol.

Exclusion Criteria:

* Individuals who are not a member of the study family and individuals with high HDL's and elevated LDL and/or triglycerides.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Douglas E Vaughan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02720809: Health2016: Monitoring Chronic Disease and Risk Factors in the General Population
Official title: Helbred2016: Monitorering af Kroniske Sygdomme og Risikofaktorer i Befolkningen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Micronutrient Deficiency
Cardiovascular Disease
Allergy
Respiratory Disease
Keywords: micronutrients
blood pressure
allergy
lung function
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years.

Brief summary: Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.

Detailed description: A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status). Trends in these parameters over time will be assessed.

Eligibility criteria: Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Change in micronutrient status from 2006 to 2016
timeFrame: 10 years
Secondary outcomes:
measure: Change in HbA1C from 2006 to 2016
timeFrame: 10
measure: Change in allergic respiratory disease from 2006 to 2016
timeFrame: 10 years
measure: Change in prevalence of hypertension from 2006 to 2016
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Centre for Prevention and Health
state: Glostrup
Study officials:
affiliation: Center for Health, The Capital Region of Denmark
name: Allan Linneberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060709: Transcutaneous Measurement of Carbon Dioxide Versus Current Sedation Practices in Sedated Patients
Official title: Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Keywords: Carbon dioxide
TcC02
Hypoventilation
endoscopic
elective colonoscopy and requiring sedation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 250
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 undergoing elective colonoscopy and requiring sedation

Brief summary: Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?


Eligibility criteria: Inclusion Criteria:

* Patients requiring sedation for colonoscopy

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?
timeFrame: one year
Secondary outcomes:
measure: To verify if there is an association with the following variables: age, gender, weight, length, ASA-classification, sedation depth (BIS), co-morbidity, diagnostic or therapeutic colonoscopy.
timeFrame: one year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: J K Oosterhuis, Drs
role: STUDY_DIRECTOR
References:
Clinical trial NCT02385409: Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty
Official title: Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty - A Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Patient Blood Management
Preoperative anemia
Hip replacement
Knee replacement
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2015-03-11
Enrollment: 900
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: All patients scheduled for elective primary hip- and knee replacement during a 1 year sampling period at the department of orthopedic surgery, Hvidovre Hospital, Denmark

Brief summary: Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Detailed description: Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.

However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Scheduled for elective primary hip- or knee replacement.

Exclusion Criteria:

* Not possible to obtain preoperative blood sample.

Primary outcomes:
measure: Anemia Classification - Biochemical classification from preoperative venous blood samples
timeFrame: Date of preoperative blood sampling
Secondary outcomes:
measure: Prevalence of Anemia according to WHO definitions
timeFrame: Date of preoperative blood sampling
measure: Proportions of non-anemic patients with low irons stores
timeFrame: Date of preoperative blood sampling
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Department of orthopaedic surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Øivind Jans, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03253809: Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
Official title: Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiomyopathies
Congestive Heart Failure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nonrandomized survey of different pacing sites in the coronary veins.
Primary purpose: BASIC_SCIENCE

Brief summary: LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.

Detailed description: During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study.

The patient will then receive the left ventricular pacing lead in the standard manner.

Eligibility criteria: Inclusion Criteria:

* Standard implantation for cardiac resynchronization ICD or PM implantation
* Cardiomyopathy with LVEF \<35%
* QRS duration greater than 120 msec

Exclusion Criteria:

- Age less than 18 years

Primary outcomes:
measure: QRS Frequency at Each Paced Location
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mark J Niebauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04231409: Fast-Acting Subperception Study (FAST)
Official title: Study to Demonstrate the Value of Fast-Acting Subperception (FAST) Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain (COMBO Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 41
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain


Eligibility criteria: Key Inclusion Criteria:

* Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
* 22 years of age or older at time of enrollment
* Able to independently read and complete all questionnaires and assessments provided in English
* Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Primary outcomes:
measure: Overall Pain Responder Rate
timeFrame: 3 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Center for Pain and Supportive Care
state: Arizona
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: University of California, San Diego
name: Mark Wallace
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00796809: Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
Official title: Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coccidioidomycosis
Rheumatoid Arthritis
Keywords: TNF inhibitors
Biologic agents
coccidioidomycosis
Rheumatoid arthritis
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2008-11-24
Enrollment: 598
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona

Brief summary: The goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients receiving anti-TNF and other biologic agents for inflammatory arthritis in Tucson, Arizona.

Detailed description: Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000.

Eligibility criteria: Inclusion Criteria:

* All active patients with an inflammatory arthritis seen at the University of Arizona from January 2000

Exclusion Criteria:

* None

Primary outcomes:
measure: Determine the incidence rate and calculate the risk of coccidioidomycosis in patients receiving various anti-TNF agents or other biologics, and patients not receiving these agents for their inflammatory arthritis
timeFrame: one year
Secondary outcomes:
measure: To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug.
timeFrame: One year
measure: To compare number of disseminated cases of coccidioidomycosis in each group
timeFrame: One year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona - Arizona Arthritis Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Berchman A Vaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: