louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06435130: The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential
Official title: The Impact of Chokeberry Bioproducts Consumption on Metabolic Parameters and the Antioxidant Potential of Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Diabetes Mellitus
Hypertension
Obesity
Hypercholesterolemia
Keywords: chokeberry
juice
fiber
diet
intervention
diabetes
obesity
hypertension
hypercholesterolemia
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 102 people (67 women and 35 men) with metabolic disorders were included in the interventional study
Primary purpose: PREVENTION

Brief summary: Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.


Eligibility criteria: Inclusion Criteria:

* age 30-65 years,
* low or moderate physical activity.

Exclusion Criteria:

* age \<30 and \>65 years,
* high physical activity,
* obesity (class II),
* diabetes (all types),
* gastric ulcer,
* acute or chronic gastritis,
* intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders,
* taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy,
* high physical activity,
* pregnancy,
* breastfeeding.

Primary outcomes:
measure: Change in waist circumference
timeFrame: 12 weeks
measure: Change in blood pressure
timeFrame: 12 weeks
measure: Change in glycated hemoglobin
timeFrame: 12 weeks
measure: Change in glucose level
timeFrame: 12 weeks
measure: Change in LDL-cholesterol
timeFrame: 12 weeks
measure: Change in aspartate transaminase (AST) level
timeFrame: 12 weeks
measure: Change in antioxidant potential of serum
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Bialystok
Study officials:
affiliation: Medical University of Bialystok
name: Malgorzata E. Zujko, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811330: Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
Official title: Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aortic Valve Stenosis
Ventricular Hypertrophy
Keywords: Left ventricular hypertrophy
Aortic valve stenosis
Aortic valve replacement
Cardiopulmonary bypass
Statins
Myocardial preconditioning
Left ventricular reverse remodeling
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 70 years and \< 80 years
* Severe aortic valve stenosis
* Indication for aortic valve replacement by bioprothesis
* Ejection fraction \> or = 50%
* Without treatment with statin- No renal failure
* Informed consent signed

Exclusion Criteria:

* Ischemic heart disaese
* Concomitant surgery to aortic valve replacement
* Emergency surgery- Known intolerance for statin
* Pregnant woman

Primary outcomes:
measure: ♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months).
timeFrame: 1 year
Secondary outcomes:
measure: Phase I: To study changes on mitochondrial function, reactive oxygen species, and perioperative systolic and diastolic functions. Phase II: To study changes on clinical status, systolic and diastolic functions during the one-year follow-up.
timeFrame: 1 year
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Cardio-VasculaireHôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Michel KINDO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211130: Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
Official title: Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke, Ischemic
Keywords: medication adherence
self-management
antithrombotic
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Saint Luke's Health System
First posted: 2017-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.


Eligibility criteria: Inclusion Criteria:

* age ≥50 years old
* receives post-stroke care with Saint Luke's Neurological Consultants
* prescribed at least 1, once a day, antithrombotic medication
* able to provide informed consent
* able to open an electronic cap
* able to self-administer medications
* has or has access to a telephone
* has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).

Exclusion Criteria:

-

Primary outcomes:
measure: Acceptability and feasibility
timeFrame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary outcomes:
measure: Social Support
timeFrame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
measure: Perceived Health
timeFrame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
measure: Personal Systems Behaviors
timeFrame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
measure: Medication Adherence
timeFrame: after randomization through end of maintenance phase for a total of 3 months
Other outcomes:
Locations:
city: Parkville
country: United States
facility: Jennifer Wessol
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Jennifer L. Wessol, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Cynthia L. Russell, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04898530: Diet Patterns in IBD in Central Texas
Official title: A Cross-sectional Assessment of Diet in Patients With IBD in Central Texas
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with inflammatory bowel disease

Brief summary: The purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with IBD in Central Texas.


Eligibility criteria: Inclusion Criteria:

* any patient 18years of age or older with inflammatory bowel disease

Exclusion Criteria:

* unwilling to participate
* diagnosis of IBD unable to be verified

Primary outcomes:
measure: diet patterns
timeFrame: 6 months
measure: diet preferences
timeFrame: 6 months
measure: diet impact
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School, UT Austin
state: Texas
Study officials:
References:
Clinical trial NCT02407730: EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies
Official title: EFFects of Thrombophilia on the Outcomes of Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Rate
Embryo Implantation
Reproductive Techniques
Thrombophilia
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 687
Sex: FEMALE
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 women 18 years or older undergoing ART

Brief summary: Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART.

Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum


Eligibility criteria: Inclusion Criteria:

* women undergoing ART
* age 18 years or older

Exclusion Criteria:

* ongoing anticoagulant therapy
* previous venous thromboembolism
* no informed consent

Primary outcomes:
measure: Live birth rate
timeFrame: Participants will be followed for the duration of the pregnancy, an expected average of 9 months
Secondary outcomes:
measure: implantation rate
timeFrame: Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Universita degli Studi G. d'Annunzio Chieti e Pescara
Study officials:
affiliation: University G. D'Annunzio, Chieti, Italy
name: Marcello Di Nisio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04505930: Pilot HPV Vaccination in Chinese American Community
Official title: Developing and Pilot Testing a Multilevel HPV Vaccination Intervention in Chinese American Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese American families through culturally tailored interventions, and eventually increase the HPV vaccine uptake among Chinese American adolescents.


Eligibility criteria: Inclusion Criteria:

1. Self-identified Chinese Parents or legal guardian with children aged 11-18 years old;
2. The children have not received any does of HPV vaccination

Exclusion Criteria:

-

Primary outcomes:
measure: changes from baseline HPV vaccine uptake rate at 6-month follow up
timeFrame: baseline, and 6-month follow up
Secondary outcomes:
measure: change of HPV knowledge from baseline to 6-month follow up
timeFrame: baseline, and 6-month
measure: change in adolescents engagement percentage
timeFrame: baseline, and 6-month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Asian Health, Lewis Katz School of Medicine, Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Grace X Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080230: The Effect of Resilience Psychoeducation Program Based on Positive Psychotherapy on Nurses
Official title: The Effect of Resilience Psychoeducation Program Based on Positive Psychotherapy on Nurses Resilience and Balanced Life Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Keywords: Psychoeducation Program
Nurses
Adult resillience scale
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Effect of Resilience Psychoeducation Program Based on Positive Psychotherapy on Nurses

Detailed description: Based on the principles of positive psychology, Positive Psychotherapy integrates symptoms with strengths, resources with risks, weaknesses with values, and hopes with regret to understand the natural complexities of human experiences in a balanced way. This includes cognitive restructuring of the individual, reviewing expectations, and acquiring new goals.

Resilience is a person's process of adapting, resilience, or the ability to successfully cope with change/disaster against major stressors such as a trauma, a threat, a tragedy, or familial and relational distress, serious health problems, workplace and financial problems. It is stated that people with high psychological resilience are more successful in adapting to change and struggling against obstacles, and people with high psychological resilience experience less emotional exhaustion.10 Possible risky situations that individuals encounter in their work life and the protective factors they have also affect their psychological resilience. It is also stated that psychological resilience is an important concept for nurses who are faced with many risk factors, especially in business life, and who have to provide professional care to patients who are in difficult situations and in need, and who have to comfort the patient.1 The effectiveness of developing and strengthening psychological resilience in coping with the stressful environment of nursing has been proven. It is stated that among the coping resources of nurses, adequate rest, self-care and social support are of great importance and that these resources are positively related to the quality of life.

The aim of this research is to determine the effect of the Psychological Resilience Psychoeducation Program Based on Positive Psychotherapy on the resilience of nurses and to determine their balanced life skills.

Eligibility criteria: Inclusion Criteria:

* Working as a nurse at Düzce University Health Application and Research Center
* Individuals who voluntarily agree to participate in the research will be included.

Exclusion Criteria:

* The acute phase of a psychiatric illness

Primary outcomes:
measure: Resilience Scale for Adults scores
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Duzce University
state: Duzce
Study officials:
References:
Clinical trial NCT01291030: The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
Official title: The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism
Renal Transplantation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2011-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.


Eligibility criteria: Inclusion Criteria:

* Renal transplantation recipients
* \> 18 years of age
* more than 4 months post-transplantation
* Hypomagnesemia \< 1,8 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter) at least 1 month apart.

Exclusion Criteria:

* Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
* Biopsy that proves acute rejection and consecutive treatment with corticosteroid boluses less than 2 months before inclusion
* Serum creatinine \> 3 milligram/deciliter
* Active infection (C reactive protein \> 3 milligram/deciliter)
* Severe hypomagnesemia (\< 1,2 milligram/deciliter)
* Hypokalemia (\< 3,5 milli-equivalent/liter)
* Severe hypocalcemia (\< 6,5 milligram/deciliter)
* Intake of digoxin
* Intake of magnesium supplementation up to 2 weeks before randomization.

Primary outcomes:
measure: Evaluation of change in insulin resistance/secretion
timeFrame: after 6 months
Secondary outcomes:
measure: Evaluation of change in Hemoglobin A1c (HbA1C)
timeFrame: after 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Steven Van Laecke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744530: Cardiac RadiothErapy for VEntricular Tachycardia II
Official title: Cardiac RadiothErapy for VEntricular Tachycardia II - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia (VT)
Keywords: ventricular tachycardia
STAR
Stereotactic radiotherapy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 50
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 with therapy-refractory ventricular tachycardia who are scheduled for stereotactic radiotherapy ablation (STAR) are eligible for participation.

Brief summary: Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.


Eligibility criteria: Inclusion Criteria:

* Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
* Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

* Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy \< 6 months in the absence of VT
* Any condition that is deemed a contraindication in the judgment of the investigators

Primary outcomes:
measure: Change in VT burden
timeFrame: 48 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: All-cause mortality
timeFrame: 48 months
measure: Radiotherapy toxicity
timeFrame: 48 months
measure: Left ventricular function
timeFrame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: Evolution of valve disease
timeFrame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: Change of coronary artery disease
timeFrame: Baseline, 2 years and 4 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: