louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01206439: An Advanced Echocardiographic Evaluation of Nebivolol
Official title: An Advanced Echocardiographic Evaluation of Nebivolol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2010-09-21
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Detailed description: Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of hypertension
2. Written informed consent before initiation of any study related procedure
3. Baseline Blood pressure \> 140 systolic or \>90 diastolic if on no antihypertensive therapy.
4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.

Exclusion Criteria:

1. Physical limitations resulting in a limited ability to walk on treadmill for stress echo
2. Intolerance to beta blockers
3. On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
4. Currently pregnant or breast feeding.
5. LFT \> 3 X ULN
6. HgA1C \> 7
7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
8. Unwilling to follow protocol or return for study related procedures.
9. Any of the following conditions:

   Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
10. Any other medical condition that in the PI's opinion could affect myocardial function.
11. Current ETOH or illicit drug abuse -

Primary outcomes:
measure: Change in Systolic and Diastolic Myocardial Function
timeFrame: Baseline to day 180
Secondary outcomes:
measure: Exercise Tolerance
timeFrame: Baseline to day 180.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jack Rubinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02297139: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
Official title: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Indications Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
* Receiving dasatinib at the time of signature of informed consent
* Males and Females, ages 18 and older

Exclusion Criteria:

* All patients previously discontinued from a dasatinib study for any reason
* Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* History of allergy to dasatinib

Primary outcomes:
measure: Number of Participants Who Received Dasatinib Treatment
timeFrame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
measure: Duration of Treatment
timeFrame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
measure: Number of Participants With Serious Adverse Events
timeFrame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Other outcomes:
Locations:
city: Besancon
country: France
facility: Local Institution
city: Kraków
country: Poland
facility: Local Institution - 0006
state: Małopolskie
city: Chorzow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution - 0003
city: Wroclaw
country: Poland
facility: Local Institution - 0002
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01380639: Effects of Vibration Training on Exercise Capacity in COPD-patients
Official title: Effects of Vibration Training During a Three-week Rehabilitation on Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD III/IV
6-Minutes-Walking-Distance
Vibration training
Galileo
Pulmonary rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe disease other than COPD, that could influence the results of the study
* Abuse of alcohol or drugs
* Simultaneously participation in another study
* Tachypnea (\>30/min)
* Severe exacerbation during rehabilitation
* Cardiac insufficiency (NYHA IV)
* Myocardial infarction during the last 6 weeks
* Mental-health problem
* Pregnancy
* Known HIV-infection
* Slipped disk
* Acute discopathy
* Acute thrombosis
* Implants in trained regions of the body (lower extremities)
* Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
* Acute tendinopathy in trained regions of the body
* Acute hernia
* Fresh fractures, wounds or scars in trained regions of the body
* Gallstones or stones in the urinary tract collection system

Primary outcomes:
measure: 6-Minute-Walking-Distance
timeFrame: day 1, day 19
Secondary outcomes:
measure: Body Composition
timeFrame: day 1 and 19
measure: Isometric Maximum Handgrip Force
timeFrame: day 1, day 19
measure: BODE-Score
timeFrame: day 1, day 19
measure: Lung Function
timeFrame: day 1
measure: Arterial Blood Gas
timeFrame: day 1
measure: Brain Natruretic Peptide (BNP)
timeFrame: day 1, day 19
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinikum Berchtesgadener Land
Study officials:
References:
Clinical trial NCT06425822: Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias
Official title: Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Remodeling
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-05-22
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: Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia.

Brief summary: The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion.

The main questions it aims to answer are:

* Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation?
* Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it?
* What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?


Eligibility criteria: Inclusion Criteria:

* Absence of a prior history of atrial fibrillation or flutter.
* Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.

Exclusion criteria:

* Presence of thrombus in the left atrial appendage.
* Complications related to the index procedure.
* Insufficient quality of the left atrial electroanatomical map.

Primary outcomes:
measure: Substrate characterization of the left atrium.
timeFrame: 18 months
measure: Functional characterization of the left atrium.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
measure: Incidence of atrial fibrillation during follow-up.
timeFrame: 12 months
measure: Incidence of myocardial infarction during follow-up
timeFrame: 12 months
measure: Incidence of stroke during follow-up
timeFrame: 12 months
measure: Incidence of transient ischemic attack incidence during follow-up
timeFrame: 12 months
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Andrea Sarkozy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877122: Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.


Eligibility criteria: Inclusion Criteria:

1. Male patients \>=20 years =\<85 years old
2. Patients with Unilateral hernia
3. Patients without previous operations in lower part of abdomen
4. Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
5. Patients capable to participate during the period of the trial

Exclusion Criteria:

1. Previous hernia repair at the same site
2. Incarcerated hernia
3. Strangulated hernia
4. Patients to whom and open surgery cannot be indicated
5. Previous urological surgery
6. Immune incompetence of patient: AIDS, vesical fibrosis, etc.
7. Patients with AIHD or patients who take immunosuppressive drugs
8. Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
9. Patients with kidney disease (creatinine\>2.0mg/dL)
10. Patients on anti-coagulants
11. Patients with severe systematic disease
12. Patients with malignant tumor
13. Patients with infection or with the predicted problem of surgery site healing
14. Participation in another clinical study within the last 30 days
15. Patients whose participation is considered inappropriate according to other except above mentioned clinical condition

Primary outcomes:
measure: pain score (10-point Visual Analogue Scale)
timeFrame: Day90 after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samyang Biopharmaceuticals
Study officials:
affiliation: Eulji Medical Center
name: Taeil Son, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447822: Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)
Official title: A Prospective Randomized Controlled Study to Evaluate Feasibility and Safety of Early Steroid Withdrawal After 6mg/kg vs 4.5mg/kg Thymoglobulin Induction Therapy in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Failure
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with renal failure from 18 to 70 years of age
* Candidates for cadaveric or living donor kidney transplantation
* Patients who are able and willing to consent the protocol of the study

Exclusion Criteria:

* Patients who have been receiving immunosuppressive therapy before transplantation
* Patients who have received an investigational medication within the past 30 days
* Patients who have a known contraindication to the administration of antithymocyte globulin
* Patients who are suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
* Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives

Primary outcomes:
measure: A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
timeFrame: 12 months after kidney transplantation
Secondary outcomes:
measure: Pathologic findings according to Banff 2013 criteria
timeFrame: 1 day at the time of biopsy
measure: Overall rate of acute rejection
timeFrame: 12 months after kidney transplantation
measure: The rate of steroid-free immunosuppressive regimen
timeFrame: 12 months after kidney transplantation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06256822: Technology-Based Breastfeeding Training After Cesarean
Official title: Effect of Technology-Based Breastfeeding Training After Cesarean on Breastfeeding Success and Self-Efficacy of Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section; Dehiscence
Breast Feeding
Self Efficacy
Keywords: breastfeeding success
cesarean
education technology
breastfeeding self-efficacy
virtual reality
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mothers who gave birth with cesarean section

Brief summary: Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy.

Method: The research was designed as a prospective randomized controlled study. In total, 66 women were included in the study, with 31 in the control group and 35 in the intervention group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours after cesarean. Research data were collected with the sociodemographic information form, LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding Self-Efficacy Scale. The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.


Eligibility criteria: Inclusion Criteria:

* The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.

Exclusion Criteria:

* Mothers who did not give birth by cesarean section, did not receive breastfeeding counseling during pregnancy, had visual or hearing impairment, or had any neurological disease were not included in the study.

Primary outcomes:
measure: Breastfeeding Diagnostic and Assessment Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT02060422: Mindfulness-based Psychotherapy for Drug-resistant Epilepsy
Official title: Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Stress
Keywords: Epilepsy
Drug-resistant epilepsy
Seizure
Mindfulness
Stress
Psychotherapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 60
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: Psychological problems are prevalent among patients with drug-resistant epilepsy. The bi-directional interaction between psychological well-being and seizure have been recognized in recent years. Reduction of psychological stress has the potential to improve seizure manifestation.

The present study uses an assessor-blinded prospective randomized controlled trial to evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social support on improving psychological well-being, seizure control and cognitive performance among adult patients with drug-resistant epilepsy.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of epilepsy
* over 18 years of age
* resistant to pharmacological treatment according to the ILAE guideline
* no previous history of neurosurgery
* adequate level of reading and understanding ability to fill in questionnaires
* capable to communicate with the investigator with considerable expressive capacity
* patients who agree to cooperate with the study procedures required by the protocol
* patients who understand the nature of the study, agree to participate and sign the informed consent form

Exclusion Criteria:

* with primary diagnosis of substance use disorder, mood disorder, bipolar affective disorder, psychosis, or organic mental disorder
* with diagnosis of learning disability or mental retardation

Primary outcomes:
measure: Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention
timeFrame: Baseline, 4-week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK Division of Neurosurgery, Faculty of Medicine
Study officials:
affiliation: Division of Neurosurgery, Faculty of Medicine, CUHK
name: Venus Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01146522: Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
Official title: A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperlipoproteinemia
Keywords: Familial hyperchylomicronemia
Lipoprotein lipase deficiency
Hyperlipoproteinemia
Triglycerides
Hypertriglyceridemia
LCQ908
Hyperlipoproteinemia associated with lipoprotein lipase deficiency
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.


Eligibility criteria: Inclusion Criteria:

* Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
* Non breast feeding women.
* Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

* uncontrolled type 1 or type 2 diabetes mellitus,
* active pancreatitis (the month prior to study start),
* history of drug or alcohol abuse within the 12 months prior to dosing,
* or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Fasting and postprandial plasma triglycerides
timeFrame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)
Secondary outcomes:
measure: Blood concentration to characterize LCQ908 kinetics
timeFrame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose
measure: Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)
timeFrame: after 3 weeks of treatment with each dose
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5.