louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01922544: EP-Catheter Guided CS-Lead Implantation
Official title: Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Reduced Left Ventricular Ejection Fraction
Left Bundle Branch Block
Keywords: heart failure
cardiac resynchronization therapy
coronary sinus lead
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic heart failure and reduced left ventricular ejection fraction. Asynchronic contraction of left and right ventricle was reflected by QRS duration \> 120 ms in left precordial leads.

Brief summary: In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.


Eligibility criteria: Inclusion Criteria:

* CRT implantation due to heart failure
* full documented data

Exclusion Criteria:

* previous pacemaker/ICD/CRT implantation

Primary outcomes:
measure: Total Fluoroscopy Time
timeFrame: During implantation
measure: Contrast medium account
timeFrame: During surgical procedure
Secondary outcomes:
measure: Successful implantation
timeFrame: During surgical procedure
Other outcomes:
measure: Procedure related complications
timeFrame: 24 hours after start of surgery
Locations:
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
Study officials:
References:
Clinical trial NCT00799344: REVEAL Study: Vessel Healing After Angioplasty
Official title: Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) Trial: Rationale, Objectives and Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Stent
Lead sponsor: CeloNova BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that have two significant short lesions

Brief summary: To address early vessel healing and thrombus formation after deployment of three distinct groups of stents

Detailed description: A prospective, randomized study providing new evidences on early vessel healing and thrombus development after stenting with different devices.

Eligibility criteria: Inclusion Criteria:

* Lesion length ≤ 20 mm
* Two significant short lesions

Exclusion Criteria:

* Life expectancy \< 1 year
* Left ventricular ejection fraction (LVEF) \<30%
* Chronic kidney disease

Primary outcomes:
measure: percentage of "healed stent struts" at 28-32 days
timeFrame: 30 days
Secondary outcomes:
measure: Measurement of neointimal growth on stent struts
timeFrame: 30 days
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Ferrarotto Hospital
state: Sicily
Study officials:
affiliation: Ferrarotto Hospital, University of Catania
name: Corrado Tamburino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: La Manna A, Prati F, Capodanno D, Di Salvo M, Sanfilippo A, Barrano G, Monaco S, Tamburino C. Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient. J Cardiovasc Med (Hagerstown). 2011 May;12(5):328-33. doi: 10.2459/JCM.0b013e3283406428.
Clinical trial NCT00471744: HEAD-Study Optimizing the Treatment of Children With BECTS
Official title: HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy, Rolandic
Keywords: benign epilepsy
pediatrics
children
rolandic epilepsy
levetiracetam
sulthiame
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2007-05-10
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.


Eligibility criteria: Inclusion Criteria:

1. Age between 6 and 12 years
2. Weight between 15 kg and 60 kg
3. At least two preceding seizures within the last six months before study start
4. Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
5. Diagnosis of BECTS
6. Written informed consent from parents and child

Exclusion Criteria:

1. Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep \[CSWS\], Landau-Kleffner-syndrome)
2. Preceding treatment with antiepileptic drugs
3. Mental Retardation (intelligence quotient \[IQ\] \<85)
4. Focal neurological deficit
5. Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
6. Participation in another clinical trial within the last 30 days

Primary outcomes:
measure: To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
timeFrame: 6 months
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 6 months
measure: Cognitive effects
timeFrame: 6 months
measure: Efficacy on EEG pattern
timeFrame: 6 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Dr. von Haunersches Kinderspital
Study officials:
affiliation: Ludwigs-Maximilians-Universität München
name: F Heinen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milburn-McNulty P, Panebianco M, Marson AG. Sulthiame monotherapy for epilepsy. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD010062. doi: 10.1002/14651858.CD010062.pub3.
Clinical trial NCT01433744: Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Official title: Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Atherosclerotic Cardiovascular Disease
Keywords: C-Reactive protein
risk
Lead sponsor: State University of Maringá
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in patients with chronic periodontitis in comparison with those without periodontal disease and that the non-surgical periodontal treatment would decrease levels of CRP in patients with chronic periodontitis.


Eligibility criteria: Inclusion Criteria:

Patients should have ≥ 20 teeth present; (ii) absence of oral soft tissue lesions; (iii) have ≤ 3 carious lesions in all teeth. In addition, to be included in the Test group the subject had to present chronic periodontitis (involvement of at least 5 teeth with at least one site presenting probing depth (PD) ≥ 5 mm and clinical attachment loss (CAL) ≥ 3 mm) while to be included in the Control group the patient had to exhibit periodontal healthy (bleeding on probing (BOP) \< 30% of the sites and absence of any PD \> 4mm associated with BOP).

Exclusion Criteria:

(i) periodontal disease treatment in the previous six months; (ii) aged less than 35 years; (iii) systemic conditions such as history of CVD or any other chronic or immunologic diseases and the use of related drugs in the previous six months; (iv) smokers or former smokers; (v) pregnant or lactating women; (vi) hypertension (\>140 systolic and \> 90 diastolic mmHg); (vii) obesity (Body Mass Index (BMI) ≥ 30 kg/m²); (viii) levels of HDL-cholesterol \> 35.0 mg/dL (ix) levels of LDL-cholesterol \< 160.0 mg/dL (x)levels of triglycerides \< 400.0 mg/dL and (xi) levels of glucose levels \< 100 mg/dL.

Primary outcomes:
measure: C-Reactive Protein levels
timeFrame: Baseline and 60 days after treatment
Secondary outcomes:
measure: The effect of non-surgical periodontal treatment on patients with chronic periodontitis
timeFrame: Baseline and re-evaluation 60 days after the end of treatment
Other outcomes:
Locations:
city: Maringá
country: Brazil
facility: Departament of Dentistry of State University of Maringá
state: Paraná
Study officials:
References:
Clinical trial NCT01698944: Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
Official title: Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the effect of growth hormone on left ventricle morphology and function (systolic and diastolic).


Eligibility criteria: Inclusion Criteria:

* Adult growth hormone deficiency
* At least 2 years without growth hormone treatment

Exclusion Criteria:

* Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
* Pregnancy

Primary outcomes:
measure: Left Ventricular systolic function
measure: Left Ventricular diastolic function
Secondary outcomes:
measure: Body composition
measure: Fasting glucose
measure: HbA1c (glycosylated haemoglobin)
measure: Oral glucose tolerance test (OGTT)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06098144: Smoking Cessation Program in the Construction Sector
Official title: Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Tobacco Use Cessation
Tobacco Smoking
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2023-10-24
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.


Eligibility criteria: Inclusion Criteria:

Company leaders:

* ≥ 18 years
* Involved in decision making
* Willing to participate in the implementation development and evaluation

Safety Managers:

* ≥ 18 years
* Be a safety manager
* No plans to leave the company within the next year
* Bilingual
* Willing to receive training in smoking cessation treatment
* Willing to deliver the smoking cessation treatment to workers

Construction Workers:

* Be a construction worker
* ≥ 18 years
* Have smoked on average 5 or more cigarettes daily for the past year
* Willing to make a serious quit attempt in the next 30 days
* Planning to stay in the company for the next 6 months
* Own a telephone and plan to keep it active for the next 12 months

Exclusion Criteria:

Safety Managers:

- Current cigarette smoker

Primary outcomes:
measure: Program Effectiveness Measure in Percentage
timeFrame: Up to 4 years
measure: Program Cost-Effectiveness Measured by Number of U.S Dollars
timeFrame: Up to 4 years
measure: Program Cost-Effectiveness Measured by Quality Adjusted Life Years
timeFrame: Up to 4 years
Secondary outcomes:
measure: Program's Implementation- Acceptability Measured by Likert Scale
timeFrame: Up to 4 years
measure: Program's Implementation- Feasibility Measured by Likert Scale
timeFrame: Up to 4 years
measure: Program's Implementation- Sustainability Measured by Likert Scale
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Don Soffer Clinical Research Center
state: Florida
Study officials:
affiliation: tasfar@miami.edu
name: Taghrid Asfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03607344: Day Case Laparoscopic Sacrocolpopexy, a New Management
Official title: Day-case Laparoscopic Sacrocolpopexy, a Compelling Option in Selected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Sacrocolpopexy
Day case surgery
Laparoscopic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort is selected from the investigators institution. All consecutive patients undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist surgeons at the investigators university hospital, with an ambulatory department, was enrolled.

Brief summary: Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant.

Detailed description: Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects approximately 40% of female population. Of these 12% are symptomatic and suffer of physical and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal vault .

With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .

With rising health care cost and its inherent economic burden, safe and viable options to reduce cost must be sought.

Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe, especially in Great Britain. But the High Authority of Health in France found a delay in its development.

In view of the evolution of surgical and anesthetic techniques, and the low complication rate of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory setting.

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic anterior, apical and/or posterior compartment prolapse
* Patients with stage 2 or greater, according to the POP-Q classification
* Patients with a body mass index (BMI) \< 30
* Patients with an American Society of Anesthesiologist (ASA) score \< ou = 3.

Exclusion Criteria:

* Patient with prior history of pelvic cancer surgery and radiotherapy of the pelvis

Primary outcomes:
measure: The success rate of outpatient laparoscopic sacrocolpopexy
timeFrame: 1 month post-operative
Secondary outcomes:
measure: Post-operative adverses events
timeFrame: 1 month post-operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02090244: Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Official title: Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Keywords: PTH
Spinal stenosis
Teriparatide
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Medical Research Council of Southeast Sweden
First posted: 2014-03-18
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.

Detailed description: 100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control.

Primary outcome: The rate of healing at 6 months on CT Scans. Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

Exclusion Criteria:

* •dementia or psychiatric disorder

  * known malignancy \< 5 years prior to fracture
  * calcium above reference value
  * signs of liver disease
  * creatinine over ref. value
  * inflammatory joint disease
  * alcohol or drug abuse
  * oral corticosteroid medication
  * long-term NSAID-treatment (=\> 3 months prior to fracture)

Primary outcomes:
measure: The rate of bone healing after spinal stenosis surgery
timeFrame: 6 months + more than 2 years postoperatively.
Secondary outcomes:
measure: Pain
timeFrame: At 3 and 6 months.
measure: Function
timeFrame: At 3 and 6 months.
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Ortopedkliniken
city: Linköping
country: Sweden
facility: Ryggkliniken, US Linköping
Study officials:
affiliation: Ryggkliniken, US Linköping
name: Jon Ottesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ortopedkliniken, Kalmar, Sweden
name: Patrik Bernestrå, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333644: The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Official title: The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Cardiovascular Disease
Inflammation
Keywords: HIV Infection
Endothelial function
Cardiovascular Disease
Inflammation
Antiretroviral medication
Treatment naive
Treatment experienced
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-04-12
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treated and untreated HIV-infected individuals and HIV-uninfected individuals.

Brief summary: It is the central hypothesis of the investigators study that HIV disease is a pro-inflammatory condition, and that years of inflammation result in premature "aging' of the immune system ("immunosenescence"). Just as these changes are thought be causally associated with heart disease in the very old,the investigators postulate that these changes will be associated with early heart disease in the untreated and perhaps treated HIV disease. To address this hypothesis, the investigators will measure immunosenescence in a large cohort of patients who span the entire disease process.


Eligibility criteria: Inclusion Criteria:

* HIV controllers: positive for HIV by standard antibody serological determinations with undetectable HIV RNA level (\< 75 copies RNA/mL) in absence of therapy
* HIV non-controllers: detectable HIV RNA levels in absence of therapy
* Highly active anti-retroviral therapy responders (HAART responders): on combination antiretroviral therapy with undetectable HIV RNA levels.
* HIV-seronegative participants will also be studied.

Exclusion Criteria:

* Treated individuals that changed antiretroviral regimen within 12 weeks prior to study enrollment.
* Individuals who have started or stopped antihypertensive medication or lipid lowering medication or changed doses of these drugs within 12 weeks of the study will be excluded.
* As nitroglycerin is administered to assess endothelium-independent vasodilation, we also plan to exclude patients who have taken sildenafil, vardenafil, or tadalafil within 72 hours of the endothelial function study, or who are hypotensive (systolic BP \<100).

Primary outcomes:
measure: brachial artery flow-mediated dilatation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Priscilla Hsue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218644: Effectiveness of Proprioceptive Exercise in Neck Pain
Official title: Effectiveness of a Propioceptive Exercise Program in Subjects With Inespecific Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Proprioception
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited.

Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program.

Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.


Eligibility criteria: Inclusion Criteria:

* Neck pain (NAD I-II) of recent onset (0-3 months)

Exclusion Criteria:

* Cognitive difficulties
* Lack of commitment to attend sessions
* Subjects with pacemakers or defibrillators
* Being receiving another physiotherapeutic treatment
* Other pathologies

Primary outcomes:
measure: Intensity of Pain
timeFrame: four weeks
Secondary outcomes:
measure: Head Repositioning Test
timeFrame: four weeks
measure: Cervical movement range (CROM)
timeFrame: four weeks
measure: Pain points
timeFrame: four weeks
measure: Neck Disability
timeFrame: four weeks
measure: Health status
timeFrame: four weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Victoria Espí-López
Study officials:
affiliation: fisiotherapy
name: Gemma Victoria Espí-López
role: PRINCIPAL_INVESTIGATOR
References: