louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01497912: Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Dyslipidemia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute.

Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties.

The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes
* level of plasma LDL-cholesterol \>2.5mmol/L and/or total cholesterol \>4.5mmol/L

Exclusion Criteria:

* History of macrovascular events

Primary outcomes:
measure: Fibrin network permeability
timeFrame: 8 weeks
Secondary outcomes:
measure: platelet and endothelial microparticles
timeFrame: 8 weeks
measure: skin microvascular reactivity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
Study officials:
References:
Clinical trial NCT03695146: Heart Inflammation and Mental Stress Study
Official title: Heart Inflammation and Mental Stress Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: High blood pressure
HIV
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-03
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the neural underpinnings of cardiovascular reactivity to mental stress as a function of HIV and hypertensive risk.

Detailed description: The main objectives of the study are to assess (1) patterns of brain activity/connectivity that confers greater cardio-autonomic/emotion regulation, (e.g., heart rate variability, blood pressure reactivity, inflammatory-immune activation, etc.), during rest, mental stress, and anger-related distress, (2) whether changes in breathing pace mitigate task-based effects on cardio-autonomic-immune regulation, and (3) whether these patterns vary as a function of HIV or pre-hypertensive (HTN) status-related changes to the brain structures underlying cardioautonomic and emotion regulation.

Eligibility criteria: Inclusion criteria:

1. pre-hypertension screening.
2. HIV-antibody testing.

Exclusion criteria:

1. current use of anti-lipid, antihypertensive, or heart rate altering medications;
2. current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension;
3. current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes;
4. history of trauma, cerebral infarction or hemorrhage;
5. current diagnosis and/or treatment for hypertension;
6. severe cognitive impairment;
7. current treatment or diagnosis of psychiatric illness;
8. metal implants or debris within the body; or pregnancy;
9. body mass index \> 35;
10. use of hormone replacement therapy; and current smoker.

Primary outcomes:
measure: Change in heart rate variability
timeFrame: Baseline, pre-intervention and up to 60 minutes post-intervention
Secondary outcomes:
measure: Change in cytokine expression in peripheral blood mononuclear cells
timeFrame: Baseline, pre-intervention and up to 60 minutes post-intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami, College of Arts and Sciences
name: Roger C McIntosh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06585046: Pancreatic Surgery and Risk Factors
Official title: The Risk Factors and Prognosis of Hyperglycemia Secondary to Pancreatic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Surgey
Diabetes Mellitus
Keywords: Pancreatic Surgey
Diabetes Mellitus
PCRD
Risk factor
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with pancreatic surgery in our centre.

Brief summary: The goal of this observational study is to learn about post-pancreatic surgery diabetes mellitus(PCRD).The main questions it aims to answer are:

1. What are the clinical characteristics of PCRD?
2. What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition.

The researchers will summarize the risk factors for PCRD from the PCRD group.

Detailed description: Sponsors retrospectively collected data from patients with pancreatic surgery in Changzheng centers between January 2017 and June 2024.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and \<80 years, male or female; 2. Patients who underwent pancreatic resection in pancreaticobiliary surgery since January 2017 3. Those who have previously completed a cohort study in pancreaticobiliary surgery and signed informed consent; 4. Those who have completed and banked serum specimens and pathology specimens in our hospital.

-

Exclusion Criteria:

1. Age \<18 years or ≥80 years; 2. Those with preoperative fasting blood glucose ≥5.8 mmol/l or HbA1c ≥6.0% or a history of diabetes; 3. Those with missing relevant data.

-

Primary outcomes:
measure: Incidence of glycaemic disorders（prevalence of diabetes） (postoperative fasting blood glucose/HbA1C)
timeFrame: (within 5 years after surgery)
Secondary outcomes:
measure: overall survival
timeFrame: within 5 years after surgery
measure: Disease-Free Survival
timeFrame: within 5 years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04095546: Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology
Official title: Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Borderline Personality Disorder (BPD)
Keywords: epigenetic changes
Psychotherapy
epigenetic regulation
methylation patterns
change in methylation of genes
FKBP5 gene
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Leading House for the Latin American Region (Seed Money Grant SMG 1730)
First posted: 2019-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in Basel/ Switzerland will be recruited from the routine clinical practice of the Outpatient Department of the Child and Adolescent Psychiatric Hospital.

Patients in Santiago/ Chile will be recruited from the Department of Psychiatry and Mental Health, East Campus,Faculty of Medicine, University of Chile.

Brief summary: The link between epigenetic changes as an effect of psychotherapy has been investigated recently. Genes investigated in these studies were brain-derived neurotrophic factor (BDNF), NR3C1, FKBP51, MAOA and GLUT1. Change in methylation of these genes could be a biomolecular mechanism of psychotherapy induced changes. This study project aims at providing evidence for a biological mechanism of personality disorder interventions in adolescence by investigating the link between epigenetic changes as an effect of psychotherapy. It investigates the correlation between changes in the methylation of the FKBP5 gene and psychotherapy induced changes in symptoms and functioning.


Eligibility criteria: Inclusion Criteria:

* adolescents presenting 3 or more criteria for BPD in the Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) axis II personality disorders (SCID-II)

Exclusion Criteria:

* difficulties to understand or comply with instructions
* psychotic disorders
* pervasive developmental disorders
* severe somatic or neurological disorders
* severe and persistent substance addiction
* elevated risk for complications related to blood sampling

Primary outcomes:
measure: change in methylation of the FKBP5 gene
timeFrame: after 6 months from baseline
Secondary outcomes:
measure: change in methylation of the FKBP5 gene
timeFrame: at month 3 and at month 12 after baseline.
Other outcomes:
Locations:
Study officials:
affiliation: Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)
name: Ronan Zimmermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06200246: Cardio-vascular Energy Transfer and Ventriculo-arterial Coupling in Heart Failure
Official title: Cardio-vascular Energy Transfer and Ventriculo-arterial Coupling in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Left-sided
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan Normal University
First posted: 2024-01-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises individuals experiencing decompensated heart failure within the first three days of hospital admission. It includes both newly diagnosed cases and individuals with a pre-existing heart failure diagnosis. The population is diverse, both regarding gender and etiology.

Brief summary: The goal of this pilot study is to investigate energy transfer fram the ventricle to the arteries in patients with heart failure, primary by investigating the total power.


Eligibility criteria: Inclusion Criteria:

Acute left ventricular failure due to:

* Myocardial ischemia
* Cardiomyopathy
* Myocarditis Sinus rhythm Age \>18 years

Exclusion Criteria:

Cardiogenic shock Mechanical circulatory support Respiratory treatment Inotropic infusions Tachyarrhythmias Lack of capacity to consent

Primary outcomes:
measure: Cardio vascular energy transfer in heart failure patients.
timeFrame: During first 1-3 days after admission to hospital because of decompensated heart failure.
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav hospital
Study officials:
References:
Clinical trial NCT02022046: Methylation Biosignature in Childhood Chronic Kidney Disease
Official title: Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Cardiovascular Disease
Keywords: chronic kidney disease
cardiovascular disease
nitric oxide
homocysteine
asymmetric dimethylarginine
methylation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 69
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged \<18 years visit pediatric nephrology clinic during study period

Brief summary: Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.

In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.

The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease stage 1-4
* Volunteer

Exclusion Criteria:

* pregnancy
* renal transplant
* congenital heart disease
* not able to be adherent/complaint with study procedure
* not volunteer

Primary outcomes:
measure: change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
timeFrame: from the time of enrollment, every 6 months, up to 24 months
Secondary outcomes:
measure: change from the baseline health-related quality of life at 24 months
timeFrame: from the time of enrollment, every 6 months, up to 24 months
measure: change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months
timeFrame: from the time of enrollment, every 6 months, up to 24 months
measure: change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months
timeFrame: from the time of enrollment, every 6 months, up to 24 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: You-Lin Tain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769246: Upright Back Posture Device Study
Official title: Upright Back Posture Device Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Postural Low Back Pain
Lower Back Pain
Keywords: Upright
Back
Posture
Back pain
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Upright Technologies
First posted: 2018-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled study to determine if patients between the ages of 18-50 years, with posture related low back pain, who use the Upright device demonstrate improved pain control and self perception of posture compared to those given standard ergonomic instruction.

Detailed description: Back pain is a common complaint among students. For many, back pain is directly related to poor posture while sitting and standing. Those who spend prolonged time sitting in poor posture often develop muscular imbalances leading to tight chest muscles and weakness in back muscles. The Upright system is a device which helps provide a sensory reminder to alert users when their posture is poor. The purpose of this study is to determine if patients who use the upright posture device demonstrate improved pain control and self perception of posture when compared to those given standard ergonomic instruction.

Eligibility criteria: Inclusion Criteria:

* Postural-related back pain

Exclusion Criteria:

* A diagnosis of significant scoliosis, herniated/bulging disc, lumbar spondylolysis, radiculitis, facet arthrosis, fibromyalgia, rheumatoid arthritis, seronegative spondyloarthropathy.
* Neurologic deficits on exam
* Currently in physical therapy (PT)

Primary outcomes:
measure: Score on Numeric Pain Rating Scale (NPRS)
timeFrame: 4 weeks
measure: Score on the PROMIS Pain Interference Short Form 6b
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Anna-Christina Bevelaqua, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371746: Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Official title: A Multi-Center, Three-Stage, Open-Label, Prospective, Active-Comparator-Controlled Phase 2a Study of ENV515 (Travoprost) Intracameral Implant in Patients With Bilateral Ocular Hypertension or Early Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma and Ocular Hypertension
Lead sponsor: Envisia Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
* Are currently treated with topical PGA for ocular hypertension in both eyes.
* Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.

Exclusion Criteria:

* Eye surgery (including cataract surgery) within the past 3 months.
* History of glaucoma related surgery.

Primary outcomes:
measure: Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
timeFrame: Baseline and Day 25
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Garden Grove
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Redding
country: United States
state: California
city: Morrow
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Chesterfield
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Sioux Falls
country: United States
state: South Dakota
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT04661046: Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer
Official title: Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gene Mutation-Related Cancer
Traditional Chinese Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To explore the correlation between gene mutations of metastatic colorectal cancer and TCM syndrome types based on Second-generation sequencing technology.


Eligibility criteria: Inclusion Criteria:

1. A clear pathological diagnosis is a patient with colorectal cancer;
2. Have complete TNM staging information;
3. There is a clear diagnosis of the location and time of metastasis;
4. Age ≥18 years old, ≤80 years old, male or female;
5. There is a clear time for the first treatment with Chinese medicine;
6. Patients who can receive long-term follow-up. -

Exclusion Criteria:

1. Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.;
2. Patients with double cancer, multiple or metastatic colorectal cancer;
3. Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00238446: Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients
Official title: A Prospective, Open-label, Multicenter Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients Successfully Completing the 12-month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS
Keywords: Enteric-coated mycophenolate sodium, heart transplant recipients, long term safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.


Eligibility criteria: Inclusion Criteria:

Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study

Exclusion Criteria:

Patients who did not complete the 12-month core study CERL080A2401

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: