louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05831384: Does Diabetes Related Distress Impact on Balance Glycemic ?
Official title: Does Diabetes Related Distress Impact on Balance Glycemic ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Distress
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult hospitalized patients for diabetes at IE3M.

Brief summary: The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17).

The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.

Detailed description: The health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (HbA1c) and reduced quality of life. If quarterly glycated haemoglobin (HbA1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? To our knowledge, there are few studies in France that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes.

The main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the Diabetes Distress Scale (DDS-17).

The secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.

Eligibility criteria: Inclusion Criteria:

* Patients living with type 1 or type 2 diabetes.
* Patients hospitalised in the diabetes department of the IE3M.
* Patients aged ⩾ 18 years.
* Patients agreeing to participate in this study after information.
* Beneficiary of the health insurance.

Exclusion Criteria:

* Refusal to participate.
* Inability to communicate in French.
* Inability to read or write French.
* Communication disorders.
* History of psychiatric disorders, dementia.
* Patient under guardianship or curatorship.
* Patient not affiliated to social security.
* Patient affiliated to the Aide Médicale d'Etat (AME).

Primary outcomes:
measure: Overall diabetes distress score
timeFrame: at baseline
Secondary outcomes:
measure: The The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital result (Hba1c)
timeFrame: at baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Diabetology department - Hospital of Pitié Salpêtrière - APHP
Study officials:
affiliation: Diabetology department - Hospital of Pitié Salpêtrière
name: Evelyne Alvitre, Nursing degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04351984: Transcatheter Mitral Valvuloplasty Pilot Study
Official title: Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Insufficiency
Mitral Regurgitation
Mitral Valve Regurgitation
Keywords: MitraClip
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2020-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe mitral regurgitation

Brief summary: This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation


Eligibility criteria: Inclusion Criteria:

* Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
* Age 19 and more
* Written informed consent

Exclusion Criteria:

* Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
* Active endocarditis of the mitral valve
* Rheumatic mitral valve disease
* Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

Primary outcomes:
measure: Mitral regurgitation
timeFrame: 1 month
Secondary outcomes:
measure: All cause death
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Re-hospitalization
timeFrame: 1 year
measure: Acute kidney dysfunction
timeFrame: 5 days
measure: Vascular complication
timeFrame: 5 days
measure: Bleeding
timeFrame: 5 days
measure: Successful valvuloplasty
timeFrame: 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03907384: Mat Pilates and Vascular Function in Obese Females
Official title: The Effects of Mat Pilates Training on Vascular Function in Obese Premenopausal Women With Elevated Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Elevated Blood Pressure
Lead sponsor: Marymount University
Sponsor class: OTHER
Collaborators: name: Busan University
name: Texas Tech University
name: University of Isfahan
First posted: 2019-04-09
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is associated with progressive decreases in arterial health and function. It is crucial to prevent or reduce the negative effects of aging on the vasculature by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a Mat Pilates training (MPT) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx) and endothelial function in obese premenopausal women with elevated BP.

Detailed description: Using a parallel experimental design, participants were randomly assigned to either MPT (n=14) or non-exercising control group (n=14) for 12 weeks. Participant in the MPT group trained 3 days/week . Participants' brachial to ankle PWV (baPWV), systolic and diastolic BP, AIx, plasma NO levels were measured at baseline and after 20 weeks of their assigned intervention.

Eligibility criteria: Inclusion Criteria:

* body mass index 30-40 kg/m2
* \<1 h of regular exercise per week in the previous year
* systolic/diastolic BP: 120-129mm Hg systolic BP and ˂ 80 mm Hg for diastolic BP
* Nonsmokers

Exclusion Criteria:

* body mass index ˂30 and ≥40 kg/m2
* chronic diseases
* taking oral contraceptives
* pregnancy

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Pressure Wave Reflection
timeFrame: 12 weeks
measure: Endothelial Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
Study officials:
References:
citation: Wong A, Figueroa A, Fischer SM, Bagheri R, Park SY. The Effects of Mat Pilates Training on Vascular Function and Body Fatness in Obese Young Women With Elevated Blood Pressure. Am J Hypertens. 2020 May 21;33(6):563-569. doi: 10.1093/ajh/hpaa026.
Clinical trial NCT00839384: AdvisaTM IPG Clinical Evaluation Study
Official title: Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Atrial Tachyarrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2009-02-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).

Detailed description: The Advisa IPG is an investigational dual chamber pacemaker that provides rate-responsive bradycardia pacing and diagnostics and atrial tachycardia detection and therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Advisa device. Data will be collected at baseline (enrollment), implant, 1-, 3- and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Eligibility criteria: Inclusion Criteria:

* Patients who have an IPG indication for implantation of a dual chamber pacemaker.
* Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
* Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.

Exclusion Criteria:

* Patients with a life expectancy less than the duration of the study.
* Patients with a Class III indication for permanent pacing according to ACC/AHA/NASPE 2002 guidelines.
* Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.

Primary outcomes:
measure: USADE at 1 month post implant
timeFrame: 1 month
Secondary outcomes:
measure: Advisa IPG system performance
timeFrame: 1 month
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: IKEM
Study officials:
affiliation: Medtronic Cardiac Rhythm and Heart Failure
name: Advisa Clinical Study Team
role: STUDY_CHAIR
References:
Clinical trial NCT04706884: NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY
Official title: EFFECT OF CEREBRAL OXYGEN SATURATION ON THE ETIOLOGY OF EARLY POSTOPERATIVE HYPERLACTATEMIA: NEW INDICATION FOR KNOWN MONITORING IN CARDIOPULMONARY BYPASS SURGERY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Etiology of Hyperlactathemia
Early Period After Cardiopulmonary Bypass Surgery
Washout Phenomenon
Keywords: Early Hyperlactatemia
Cerebral Oxygen Saturation,
Cardiovascular Surgery
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 43
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo elective bypass surgery and extracorporeal circulation

Brief summary: Objective: The objective of the study was to investigate a reverse correlation between blood lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

Detailed description: The objective of the prospective study was to investigate a reverse correlation between blood lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

Sixty American Society of Anesthesiologists (ASA) II-III patients were included in this study. Perioperative data, including age, weight, body surface area, gender, body temperature, preoperative co-morbidities, intraoperative and postoperative hemodynamic parameters, arterial blood gas analysis (ABG), cardiopulmonary bypass and aortic cross-clamp duration, flow rate, urine output, and blood product and inotropic agent usage, were recorded. Postoperative plasma lactate levels were measured simultaneously with cerebral tissue oxygen saturation (rSO2) in both cerebral hemispheres at 10 different time points.

Eligibility criteria: Inclusion Criteria:

* ASA) II-III patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting

Exclusion Criteria:

* Active congestive cardiac failure, intraoperative death, urgent cardiac surgery or reoperation, hemodynamic instability or need of inotropic support before the operation, the elevation of any parameters preoperatively suggestive of systemic hypoperfusion, coagulopathy, renal failure, hepatic dysfunction, local or systemic infection, and inflammation.

Primary outcomes:
measure: Differantial Diagnosis of early hyperlectathemia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
state: Atakent
city: İstanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation
name: Fevzi Toraman, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06360484: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus
Official title: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus (HBV), A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Hepatitis D
Viral Hepatitis
Lead sponsor: National Center for Gastroentestinal and Liver Disease
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted between June and September 2022, involving patients aged 16 years and above with hepatitis B virus infection. Patients attending the liver clinic or admitted at Ibn Sina Specialized Hospital were included, while those with HIV and HCV co-infection were excluded.

Brief summary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.

Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG


Eligibility criteria: Inclusion Criteria:

* patients aged 16 years and above
* with hepatitis B virus infection

Exclusion Criteria:

* patients with HIV or HCV co-infection

Primary outcomes:
measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.
timeFrame: June 2022 - September 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: National Center for Gastrointestinal and Liver Diseases
Study officials:
References:
Clinical trial NCT00615784: Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Official title: A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
AML
Bexarotene
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Confirmed diagnosis of AML as proven by bone marrow biopsy
* Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
* ECOG performance status of 0-2
* Recovered from toxicities of prior chemotherapy

Exclusion Criteria:

* History of pancreatitis
* Active alcohol abuse
* Taken bexarotene in the past
* WBC \> 10,000/uL at time of enrollment
* Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
* Significant organ disfunction: total bilirubin \> 3x ULN, AST or ALT \>3 x ULN, creatinine \> 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
* Active participant in any other investigational treatment study for AML
* Life expectancy of less than 1 month
* Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation
* Uncontrolled hyperlipidemia
* Known history of HIV
* Known active CNS involvement with AML
* Women of childbearing potential or active breast feeding

Primary outcomes:
measure: Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
timeFrame: Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
Secondary outcomes:
measure: Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy
timeFrame: Two months after 17th patient has started treatment with Bexarotene, up to 1 year.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Donald E. Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992484: Platelet Function in Patients With an Acute Coronary Syndrome
Official title: Association Between the Antiplatelet Drug Efficacy/Safety and Platelet Function in Patients Treated With Novel Platelet Inhibitors Due to an Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome (ACS)
Keywords: platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with an acute coronary syndrome

Brief summary: The aims of the study are to:

* explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome
* investigate whether a therapeutic window exist for novel platelet inhibitors
* investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario
* investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome
* investigate synergistic effects between aspirin and novel platelet inhibitors


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Acute coronary syndrome at admission
* Planned treatment with novel platelet inhibitors
* Age \>18

Exclusion Criteria:

\* Participation in interventional trials

Primary outcomes:
measure: Net clinical benefit.
timeFrame: 1 year
Secondary outcomes:
measure: MACE and Major bleeding
timeFrame: 1 year
Other outcomes:
measure: single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke.
timeFrame: 1 year
Locations:
city: Vienna
country: Austria
facility: Medical Univerity of Vienna, Department of Cardiology
Study officials:
References:
Clinical trial NCT01842984: Decreasing Loneliness in Older Adults
Official title: Increasing Social Competence and Social Integration of Older Adults Experiencing Loneliness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Social Isolation
Keywords: Loneliness
Social isolation
Depression
Older adults
Social competence
Social integration
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Ministry for Senior Citizens, Israel
First posted: 2013-04-30
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. The intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.


Eligibility criteria: Inclusion Criteria:

* age 65 or over
* residing in the Tel Aviv region

Exclusion Criteria:

* having known mental illness including schizophrenia, depression, bipolar disorder, and dementia

Primary outcomes:
measure: Change in Loneliness
timeFrame: Participants will be assessed before and after the intervention, an expected average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Tel Aviv University
name: Jiska Cohen-Mansfiels, Professor
role: PRINCIPAL_INVESTIGATOR
References: