louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00037323: Framingham Offspring Study: Psychosocial Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Depression
Atrial Fibrillation
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the relationship between psychosocial characteristics, health behaviors, and the development of coronary heart disease among participants in the Framingham Offspring Study.

Detailed description: DESIGN NARRATIVE:

Unique data sets of social, psychological, and behavioral measures were collected at the third examination of the Offspring Study from 1984 through 1987 (which results in 14 to 17 years of follow-up). Hypotheses for this research are focused toward understanding the sex and age differences in the effects these variables have on health endpoints. The research questions involve the prediction of three separate endpoints: incidence of coronary heart disease; the incidence and prognosis of atrial fibrillation; and total mortality. The analyses of psychosocial predictors for these outcomes are divided into four conceptual areas: 1) occupational status and strain, income, and employment status; 2) type A behavior, expressions of anger, hostility, and rate; 3) symptoms of depression, tension, anxiety, and feelings of aloneness; and 4) marital relationships and marital strain. These psychosocial variables will be analyzed jointly with the physiological risk factors collected at the same time to assess independence and interaction of effects. To date these psychosocial data have not been analyzed or published.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Eaker ED, Sullivan LM, Kelly-Hayes M, D'Agostino RB Sr, Benjamin EJ. Does job strain increase the risk for coronary heart disease or death in men and women? The Framingham Offspring Study. Am J Epidemiol. 2004 May 15;159(10):950-8. doi: 10.1093/aje/kwh127.
citation: Eaker ED, Sullivan LM, Kelly-Hayes M, D'Agostino RB Sr, Benjamin EJ. Anger and hostility predict the development of atrial fibrillation in men in the Framingham Offspring Study. Circulation. 2004 Mar 16;109(10):1267-71. doi: 10.1161/01.CIR.0000118535.15205.8F. Epub 2004 Mar 1.
Clinical trial NCT02480023: Assessment of Bone Mineral Density During Pregnancy
Official title: Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bone Mineral Density Quantitative Trait Locus 3
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 173
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

Detailed description: Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general obstetric clinic in a regional hospital will be recruited for the study. The obstetric department is a tertiary referral center in the region and part of a university teaching unit which catered to an annual delivery of around 10,000 women. A group of first trimester pregnant women with nearly the same age is recruited as controls.

Eligibility criteria: Inclusion Criteria:

1. females during 3rd trimister

Exclusion Criteria:

1. Secondary causes of bone loss such as hyperparathyroidism.
2. Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease.
3. Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US.
4. Taking medication known to affect bone including steroid hormones.

Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.

Primary outcomes:
measure: Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, ain shams university
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: mohamed laban, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04482023: Emotional Support and Stress Management in Patients Diagnosed With COVID-19
Official title: Emotional Support and Stress Management Activities Offered by Nurses to Patients Diagnosed With COVID-19 During Hospital Admission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Nursing care
Anxiety
Loneliness
Fear
Education
COVID-19
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CCSPT nurses

Brief summary: The aim of the study is to identify the knowledge that CCSPT nurses have in relation to care aimed at addressing anxiety, fear or loneliness and the use they have made of it in the recent crisis. The design of the research/action will also enable the training of the participating professionals to improve nursing care in these areas in the future

Detailed description: This is a cross-sectional descriptive study with a research/action design to be carried out at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The aim of this study is to identify the knowledge that CCSPT nurses have in relation to care aimed at coping with anxiety, fear or loneliness and the use that they have made of it in the recent crisis. By its design, the research/action will allow the training of these nurses to improve nursing care of these aspects in the future. This is a population-based study, in which all CCSPT nurses who have carried out care work during the COVID-19 crisis period will be invited to participate. The variables collected will be age, sex, academic level, usual work shift, care given to reduce anxiety, fear, loneliness, coping style and self-pity. Quantitative variables will be described by their mean and standard deviation, while qualitative variables will be described in absolute and relative frequencies. A linear or non-parametric correlation will be made between the score on the self-pity and coping scales and the number of actions identified and/or performed referred to by the nurses and the calculation of the Pearson or Spearman correlation coefficient, as appropriate. Comparison of the number of actions between high activity and low activity (70% cut) coping nurses using the Mann-Whitney U test

Eligibility criteria: Inclusion Criteria:

* Nurses from any unit of the Consortium Parc Taulí Corporation who have been in direct care of patients diagnosed with COVID 19 between March 9, 2020 and May 15, 2020

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of care actions identified by nurses
timeFrame: 6 months after care
Secondary outcomes:
measure: Rate of care actions taken by nurses
timeFrame: 6 months after care
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Montserrat Montaña
state: Barcelona
Study officials:
affiliation: Corporación Parc Taulí
name: Montserrat Montaña, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646723: Volunteers Adding Life in Dementia
Official title: Volunteers Adding Life in Dementia (VALID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Behavior
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Alzheimer's disease or related forms of dementia
* significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of \>39
* in nursing home for at least 30 days
* presence of a caregiver or substitute decision maker willing to consent to treatment
* no changes in psychotropic medications in the 2 weeks preceding enrolment in study

Exclusion Criteria:

* depressive symptoms presenting risk
* physically aggressive behavior posing safety risk to others
* uncontrolled pain
* currently receiving palliative care
* medically unstable with life expectancy of \< 6 months
* currently awaiting transfer to another LTC facility or hospital.

Primary outcomes:
measure: Change in Cohen-Mansfield Agitation Inventory (CMAI) score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Clinically significant reduction in agitation
timeFrame: Baseline and 12 weeks
measure: Remission of neuropsychiatric symptoms
timeFrame: Baseline and 12 weeks
measure: Change in Neuropsychiatric Inventory (NPI) score
timeFrame: Baseline and 12 weeks
measure: Change in depression symptoms (Cornell Depression in Dementia Rating Scale)
timeFrame: Baseline and 12 weeks
measure: Dementia Quality of Life (DemQoL) Scale
timeFrame: Baseline and 12 weeks
measure: Clinical Global Impression of Change (CGI-C)
timeFrame: Baseline and 12 weeks
measure: Use and dose of required medication
timeFrame: Baseline and 12 weeks
measure: Short form health survey
timeFrame: Baseline and 12 weeks
measure: Change in Modified Nursing Care Assessment Scale score
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Extendicare Kingston
state: Ontario
Study officials:
affiliation: Queen's University
name: Dallas P Seitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03609723: Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG
Official title: Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Coronary Artery Bypass Graft
Complication of Extracorporeal Circulation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 2433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)

Brief summary: A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.


Eligibility criteria: Inclusion Criteria:

* CABG using MPS® or OPCABG

Exclusion Criteria:

* use of other colloid solution than Cardioplexol ® for MPS®
* other inventions than CABG
* myocardial infarction \<7 days before CABG
* patients denial of data use

Primary outcomes:
measure: assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)
timeFrame: perioperative during hospital stay for CABG
Secondary outcomes:
measure: mortality
timeFrame: 30 days after CABG
measure: need for intensive care unit
timeFrame: perioperative during hospital stay for CABG
measure: occurence of dysrhythmia
timeFrame: perioperative during hospital stay for CABG
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: Klinik für Herzchirurgie, Universitätsspital Basel Spitalstrasse 21 4031 Basel
name: Oliver Reuthebuch, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366223: Changing Patterns of Candida Infections in Urban Medical Centers
Official title: Changing Patterns of Candida Infections in Urban Medical Centers: Emphasis on the Emergence of Non-albicans Species and Their Influence on Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Candida
Non Albicans Species
Keywords: infection
candida
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-08-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: candida blood culture

Brief summary: The purpose of this study is to determine the changing patterns of infection caused by Candida species in urban medical centers and its influence on patient outcomes. A retrospective cohort study design will be employed with the main outcome measure being hospital mortality. Secondary outcomes including microbiologic clearance of the infection, duration of hospitalization, and the intensive care unit (ICU) length of stay will also be assessed.

Detailed description: The following information that was collected as part of the patient's clinical treatment will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Eligibility criteria: Inclusion Criteria:

* All hospitalized patients with a positive blood culture for Candida will be eligible.

Exclusion Criteria:

* None

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David L Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580823: Heart and Kidney Ketones Metabolism
Official title: Exogenous Ketone Salt on Heart and Kidney Ketone Metabolism Measured by Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2020-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will have to do the 3 acute interventions
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will undergo 3 Positron Emission Tomography (PET) scans in 3 different conditions :

1. Fasting without exogenous ketone salt
2. Fasting with exogenous ketone salt supplement
3. Post-Prandial with exogenous ketone salt supplement.

Detailed description: This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt with or without food intake in middle-aged adults. Participants will have 3 different PET scan to perform :

1. Fasting without exogenous ketone salt
2. Fasting with exogenous ketone salt supplement
3. Post-Prandial with exogenous ketone salt supplement.

Eligibility criteria: Inclusion Criteria:

* Aged between 45 and 64
* Generally Healthy
* BMI between 18.5 and 27

Exclusion Criteria:

* All drugs taken on a daily basis
* Diabetes or pre-diabetes
* Digestive dysfunction
* Pregnancy or lactation
* Allergy to the supplement
* Participate in an intensive physical exercise training (more than three times a week)
* Being on a ketogenic diet or consumption of ketogenic supplement.
* More than 2 alcoholic beverages each day
* Any clinically significant anomaly in the blood profile
* Smoking
* Claustrophobia
* Being enrolled in another interventional research project or in a PET research project
* Unable to lie dorsally supine for at least 60 minutes

Primary outcomes:
measure: 11C-Acetoacetate Heart Ketone uptake
timeFrame: 60 minutes
measure: 11C-Acetoacetate Kidney ketone uptake
timeFrame: 60 minutes
measure: Cardiac Functions, telediastolic volume
timeFrame: 60 minutes
measure: Cardiac Functions, telesystolic volume
timeFrame: 60 minutes
measure: Cardiac functions, ejection fraction
timeFrame: 60minutes
Secondary outcomes:
measure: Plasma ketone
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Rearsh Centre on Aging
state: Quebec
Study officials:
References:
Clinical trial NCT06624423: Effect of Corn Silk Tea on Hypertension
Official title: Effect of Corn Silk Tea on Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Pir Mehr Ali Shah Arid Agriculture University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Subjects having hypertension were divided into 3 groups. one control and two experimental who were provided with 2g and 4g of corn silk tea twice per day for 12 weeks.


Eligibility criteria: Inclusion Criteria:

Subjects with Hypertension both male and female Subjects above age 30 years

-

Exclusion Criteria:

* Subjects below age 30 years Pregnant and Lactating women Subjects with no co morbidities

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Lipid Profile
timeFrame: 12 weeks
measure: Anthropometric Measurements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Institute of Food and Nutritional Sciences
state: Punjab
Study officials:
affiliation: Pir Mehr Ali Shah Arid Agriculture University
name: Asma Sohail, Ph.D. Food Technology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652223: Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Official title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Perennial Allergic Rhinoconjunctivitis
Allergic Asthma
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
* Mild asthma
* Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria:

* Relevant cardiovascular, renal, pulmonary or endocrine disease
* History of autoimmune disease
* Severe allergies
* History of active infectious disease
* Current diagnosis or history of malignancy
* Relevant neurological or psychiatric disorder
* Pregnancy or lactation
* History of alcohol abuse or other recreational drugs
* Use of an investigational drug within three month before enrolment
* Blood donation within 30 days before enrolment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Dermatology
Study officials:
affiliation: Cytos Biotechnology AG
name: Philipp Mueller, MD
role: STUDY_DIRECTOR
References: