louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03217981: Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil
Official title: Sepse: Critical Analysis of New Sepse Studies and Definitions and Retrospective Evaluation of Sepse Protocol Implementation at Hospital Unimed Volta Redonda
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Unimed Volta Redonda
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age hospitalized with suspected or confirmed diagnosis of sepsis at HUVR.

Brief summary: Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English language. Selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the HUVR sepsis protocol. Statistical analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014 until June 2016.


Eligibility criteria: Inclusion Criteria:

All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period.

-

Exclusion Criteria:

Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.

Individuals under the age of 18

-

Primary outcomes:
measure: Adherence to the sepsis protocol
timeFrame: From 2014 to 2016
Secondary outcomes:
measure: Sepsis mortality rate
timeFrame: From 2014 to 2016
Other outcomes:
Locations:
city: Volta Redonda
country: Brazil
facility: Vicente Lopes
state: Rio de Janeiro
Study officials:
affiliation: Director
name: Leila Auler
role: STUDY_DIRECTOR
References:
Clinical trial NCT03247881: Pilot Study on Mixed Nuts and Food Intake
Official title: Pilot Study on Mixed Nuts and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-08-14
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.

Detailed description: The condition of being overweight or obese has skyrocketed in recent decades, bringing with it many secondary health problems. Therefore, it is important to seek strategies to promote weight loss and to assist in weight maintenance after weight loss. Different diet compositions may have different effects on satiety and thus affect food choice. A pilot study will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires will also be administered to determine if personality characteristics are also influencing food choice.

Eligibility criteria: Inclusion Criteria:

* 21 to 60 Years Old
* 5 year cancer-free

Exclusion Criteria:

* pregnant, lactating, or intending to become pregnant during the study
* known allergy to study foods, including nuts
* use of tobacco products
* history of bariatric surgery or nutrient malabsorption disease or diseases requiring special diet
* Crohn's disease or diverticulitis
* suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Self report of alcohol or substance abuse within the past 12 months and/or current acute treatment or participation in a rehabilitation program for those problems (long-term participation in Alcoholics Anonymous is not an exclusion)

Primary outcomes:
measure: Body Mass will be measured
timeFrame: Day 0, prior to beginning the diet, day 8, day 29, and day 60
Secondary outcomes:
measure: Questionnaires will be administered
timeFrame: Once during the study, no specific time.
measure: Mood questionnaire will be administered
timeFrame: Day 0, Day 8, and Day 29.
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA-ARS, Beltsville Human Nutrition Research Center
name: Janet Novotny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927081: Self-management Interventions for Advanced Breast Cancer
Official title: Self-management Interventions for Pain in Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Breast Cancer Stage IV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-08-22
Enrollment: 65
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Stage IV breast cancer or recurrent metatastic breast cancer
* receiving care at Duke Cancer Institute,
* life expectancy ≥9 months as estimated by the treating oncologist,
* speak and read English,
* be at least age 18
* be able to travel to the Duke Cancer Institute

Exclusion Criteria:

* cognitive impairment as assessed by the 6-item Mini-mental Status Exam,
* Karnofsky Performance Rating of \<60 as rated by the oncology provider, an ECOG rating of 0-2
* treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months,
* currently engaged in yoga practice ≥ 1 day per week

Primary outcomes:
measure: Feasibility
timeFrame: 36 months
measure: Acceptability
timeFrame: 36 months
Secondary outcomes:
measure: Change in pain
timeFrame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
measure: Change in fatigue
timeFrame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
measure: Change in sleep disturbance
timeFrame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
measure: Change in Psychological distress
timeFrame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
measure: Change in functional capacity
timeFrame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Porter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JW, Carson KM, Olsen MK, Sanders L, Porter LS. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial. BMC Complement Altern Med. 2017 Mar 13;17(1):153. doi: 10.1186/s12906-017-1672-9.
Clinical trial NCT05836181: The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.
Official title: The Effect of Eye Movement Desensitization and Reprocessing Reducing Anxiety, Depressive Symptoms, Blood Pressure, and Heart Rate Variability in Primary Hypertension： A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Movement Desensitization and Reprocessing Intervention
Blood Pressure
Heart Rate Variability
Anxiety
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.


Eligibility criteria: Inclusion Criteria:

1. age of 20-80 years,
2. diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,
3. and able to read and understand Chinese or Taiwanese and willing to participate in this study,

Exclusion Criteria:

1. . Secondary hypertension
2. . Hypertension Crisis.

Primary outcomes:
measure: Anxiety
timeFrame: Six month
measure: depression symptoms
timeFrame: Six month
Secondary outcomes:
measure: Blood pressure
timeFrame: Six month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chen, miao-yi
state: Neihu
Study officials:
References:
Clinical trial NCT02408081: Family Focused Nursing for Elderly Medical Patients
Official title: Family-Focused Nursing for Elderly Medical Patients and Their Family: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Depression
Family functioning
Family Focused Nursing
Quality of life
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2015-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression

Detailed description: Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.

Eligibility criteria: Inclusion Criteria:

* acute hospitalized
* an expected hospitalization of minimum two days
* speak and understand Danish
* signed informed consent

Exclusion Criteria:

* dementia (evaluated by the Mini Mental State Examination \[MMSE\] \< 24)
* terminally ill patients whose survival rate is assessed to be less than a month

Primary outcomes:
measure: Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale
timeFrame: Baseline, 7 days and 6 months after the intervention
Secondary outcomes:
measure: Change in family function score on Brief Family Assessment Measure III
timeFrame: 7 days and 6 months
measure: Change in health related quality of life on Medical Outcomes Study Short Form, SF-8
timeFrame: 7 days and 6 months
measure: Change in time spent between hospitalization
timeFrame: 7 days and 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Gentofte
state: Hellerup
Study officials:
affiliation: University of Southern Denmark
name: Penille W Perboell, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06982781: FRED Retrospective Study of Intracranial Aneurysms Treatment
Official title: A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has implanted at least one observational device in China mainland

Brief summary: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment

Detailed description: Study Objective: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market.

Study Design: Post-market, retrospective, multi-center, observational clinical study Study Population: Patient who has implanted at least one observational device in China mainland.

Eligibility criteria: Inclusion Criteria:

* People in China mainland who have been treated with FRED. The patients for whom clinical data are available

Exclusion Criteria:

* Patients who met the inclusion criteria at all time points were required to be included in the study. Therefore, no specific exclusion criteria were set.

Primary outcomes:
measure: O'Kelly-Marotta, OKM grade (Imaging Evaluation of a Target Aneurysm)
timeFrame: 6 month, 1 year
measure: Raymond-Roy Grade (Adequate Occlusion Rate of Target Aneurysm)
timeFrame: 6 month, 1 year
measure: Technical Success rate
timeFrame: Immediate post-procedure
measure: Re-sheathing performance
timeFrame: Immediate post-procedure
measure: Modified Rankin Scale (mRS)
timeFrame: 6 month, 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Henan Provincial People's Hospital
name: Tianxiao Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Sheng Guan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04963881: Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).
Official title: Clinical Features and Pattern of Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy Complications
Keywords: APLS, Thrombosis, antiphosphoilipid antibodies
Lead sponsor: Fatima Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of SLE, both genders, presenting with thrombosis or pregnancy complications were studied.

Brief summary: Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications.

Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA.

Detailed description: Antiphospholipid syndrome (APS) is characterized by presence of specific antiphospholipid antibodies (aPL) with history of thrombosis and/or pregnancy morbidity.

Anti-phospholipid antibodies (aPL) is a comprehensive antibody profile which includes lupus anticoagulant \[LA\], anticardiolipin antibodies \[aCL\], and/or anti-β2-glycoprotein-I antibodies \[aβ2GPI\]). A comprehensive antibody profile is needed for both diagnosis and classification of patients with APS, most significantly for the risk assessment of both pregnancy morbidity and thrombosis.

Double positivity (LA, aβ2GPI or ACL +) and triple positivity (LA, aβ2GPI+, ACL +) may have worse outcome and the patients with double and triple positivity may have recurrent thrombotic events.

Early detection of aPL antibodies may avert patients with many complication associated with SLE as well as from major thrombotic events because the detection of aPL in SLE has been proposed as a predictive and specific tool for the diagnosis of APLS in SLE.

aPL profile in SLE patients with obstetric and thrombotic complications was analyzed, to see the association of different anti phospholipid antibodies with different clinical features of APLS in SLE patients.

Eligibility criteria: Inclusion Criteria: Diagnosed patients of SLE presenting with thrombosis \& pregnancy complication were studied

-

Exclusion Criteria:

* Patients of SLE without thrombosis

Primary outcomes:
measure: aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE.
timeFrame: 2 years
measure: B2 GPI is more prevalent in patients with antiphospholipid syndrome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01503281: Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
Official title: Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Children
Physical activity
Home-based treatment
Body mass index (z-BMI)
Percentage body fat
Waist circumference
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effect of a hospital group-based vs. home-based combined exercise-diet program for the treatment of childhood obesity.


Eligibility criteria: Inclusion Criteria:

* caucasian
* overweight/obese

Exclusion Criteria:

* Subjects with severe obesity (z-score above 2.5)

Primary outcomes:
measure: Body composition
timeFrame: 6 months
Secondary outcomes:
measure: waist circumference
timeFrame: 6 months
measure: Percentage body fat
timeFrame: 6 months
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU-Cardenal Herrera
state: Valencia
Study officials:
References:
citation: Conwell LS, Trost SG, Spence L, Brown WJ, Batch JA. The feasibility of a home-based moderate-intensity physical activity intervention in obese children and adolescents. Br J Sports Med. 2010 Mar;44(4):250-5. doi: 10.1136/bjsm.2008.046359. Epub 2008 May 7.
citation: Watts K, Jones TW, Davis EA, Green D. Exercise training in obese children and adolescents: current concepts. Sports Med. 2005;35(5):375-92. doi: 10.2165/00007256-200535050-00002.
citation: Deforche B, De Bourdeaudhuij I, Debode P, Vinaimont F, Hills AP, Verstraete S, Bouckaert J. Changes in fat mass, fat-free mass and aerobic fitness in severely obese children and adolescents following a residential treatment programme. Eur J Pediatr. 2003 Sep;162(9):616-22. doi: 10.1007/s00431-003-1247-2. Epub 2003 Jun 13.
citation: Lison JF, Real-Montes JM, Torro I, Arguisuelas MD, Alvarez-Pitti J, Martinez-Gramage J, Aguilar F, Lurbe E. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups. Acad Pediatr. 2012 Jul-Aug;12(4):319-25. doi: 10.1016/j.acap.2012.03.003. Epub 2012 May 26.
Clinical trial NCT01248481: GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin
Official title: Combined Use of a Basal Insulin and Glucobay For Reducing PPG to End Diabetes Progress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Acarbose/Glucobay®
Basal insulin
PPG (Postprandial Glycaemia)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with DM in korea

Brief summary: To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Age ≥ 18 years
* Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
* Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
* HbA1C≥7.5 and ≤10.0%

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information

Primary outcomes:
measure: Change in HbA1c
timeFrame: After 20 weeks
Secondary outcomes:
measure: Duration and dose of acarbose treatment
timeFrame: After 20 weeks
measure: Postprandial Blood Glucose
timeFrame: After 20 weeks
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02060981: Evaluation of a Decision Support Tool
Official title: Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Hypertension
Decision Making, Shared
Patient-Centered Outcomes Research
Keywords: Randomized controlled trial
Primary medication adherence
Decision-support tool
Patient-centered outcomes research
Antihypertensive medications
One-on-one patient interviews
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Foundation for Informed Medical Decision Making
First posted: 2014-02-12
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.


Eligibility criteria: Inclusion Criteria:

* does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider.
* High blood pressure diagnosis

Exclusion Criteria:

* under age 25.

Primary outcomes:
measure: Cumulative incidence of antihypertensive medication fills
timeFrame: 6 months
Secondary outcomes:
measure: Patient Interviews
timeFrame: 5 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jennifer Polinski, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: