louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01665131: The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs
Official title: The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Use of Subcutaneous ICDs Following Infection
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They have conventionally consisted of a generator sitting under the skin of the chest and leads which pass from veins in the collar bone region to the heart. Problems with these devices can necessitate extraction, with the commonest reason being infection. If extraction is required for infection then re-implantation is usually deferred for approximately one week whilst antibiotics are given so that the risk of infection of the new device can be minimised. This has considerable implications for healthcare resources. A new ICD has been developed that is entirely subcutaneous with no intravenous element. It is already in clinical use and is positioned remote from conventional ICD sites. With no intravenous element there is very little risk of infection in the blood affecting the new device. It is therefore likely to be possible to re-implant these devices immediately after extracting a conventional system. The aim of this research is to assess the outcome in patients re-implanted with this device immediately after conventional ICD system extraction. This data will be compared compared to those who have conventional systems re-implanted after the necessary delay.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling conventional criteria for ICD extraction and who require implantation of a further ICD without a need for pacing.

Exclusion Criteria:

* Indication for anti-bradycardia pacing or cardiac resynchronisation therapy
* Life expectancy \< 1 year
* Need for intravenous inotropes
* Pregnancy

Primary outcomes:
measure: Length of hospital stay
Secondary outcomes:
measure: Rate of ICD infection
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Christopher A Rinaldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06893731: Healthcare Utilization and Economic Burden of Cardiomyopathy in China
Official title: Healthcare Utilization and Economic Burden of Cardiomyopathy in China
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiomyopathies
Economic Burden
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-03-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with cardiomyopathy as the primary discharge diagnosis are recruited retrospectively from multiple centers in China between March 1, 2017 and March 1, 2022.

Brief summary: Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, and it has a huge psychological and economic burden on family members. In this study, the investigators collected clinical information and costs of patients hospitalized with cardiomyopathy and establish a database to evaluate the economic burden of cardiomyopathy.

Detailed description: This study conducted a retrospective survey of hospitalized patients with cardiomyopathy aged ≥18 years in 13 centers in China from March 1, 2017 to March1, 2022. The investigators collected demographic and clinical information as well as healthcare utilization data of patients hospitalized with cardiomyopathy so as to evaluate the economic burden of cardiomyopathy in China.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

Exclusion Criteria:

* none

Primary outcomes:
measure: total cost per hospital admission
timeFrame: through hospitalization completion, an average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital, Beijing, Beijing 100037
Study officials:
References:
Clinical trial NCT00041431: Estrogen, Cytokines and Heart Failure in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Failure, Congestive
Heart Diseases
Menopause
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-07-09
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.

Detailed description: BACKGROUND:

Congestive heart failure (CHF) is a leading cause of morbidity, mortality, and hospitalization in women. The increase in mortality suggests that postmenopausal estrogen loss may alter the phenotypic expression of CHF. Because estrogen is a potent in vitro inhibitor of pro-inflammatory cytokines (e.g., TNFa, IL-1B, IL-6), which are re-expressed by the failing myocardium in patients with CHF and are related to an adverse prognosis, the study postulates that estrogen replacement will improve the outcome of postmenopausal women with CHF.

DESIGN NARRATIVE:

The randomized, double blind study was conducted in 166 postmenopausal women with congestive heart failure due to idiopathic (i.e.nonischemic) dilated cardiomyopathy and NYHA class II or III symptoms on either combined estrogen and progestin or placebo. Women maintained their then current congestive heart failure medications for six months. Three outcomes were measured: 1) Congestive heart failure severity/functional capacity quantified by maximum oxygen consumption during metabolic stress testing; 2) Left and right ventricular remodeling quantified by electron bean CT scan; 3) quality of life assessment by the Minnesota Living with Heart Failure and Kansas City cardiomyopathy questionnaires. In addition, measurements were made of pro-inflammatory markers, that had been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduced them.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: Postmenopausal women with NYHA Class II or Class III congestive heart failure due to idiopathic dilated cardiomyopathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Steven Reis
References:
Clinical trial NCT04820231: Platelet-Rich Plasma and Hip Osteoarthritis
Official title: The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: hip osteoarthritis
platelet-rich plasma
ultrasound guidance
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients with mono-lateral hip pain , grade 1 or 2 hip osteoarthritis according to the Kellgren-Lawrence classification
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis.

Detailed description: After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.

Each patient received three times intra-articuler injections of PRP under ultrasound guidance, and they were administered once a week.

Baseline: Visual Analog Scale (VAS) including movement, rest and night, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and SF-36 assessment

1st month: VAS, WOMAC and SF-36 assessment

3rd month: VAS, WOMAC and SF-36 assessment

6th month: VAS, WOMAC and SF-36 assessment

Eligibility criteria: Inclusion Criteria:

* Hip pain VAS \> 4
* Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
* No pathologies in the laboratory and coagulation parameters

Exclusion Criteria:

* Rheumatological disease with hip involvement
* Systemic active infection
* Severe cardiovascular disease
* Malignancy
* NSAID usage in the last week
* History of hip joint surgery
* History of traumatic hip injury
* Hgb values \< 11 gr/dl
* Platelets values \< 150.000 / µl
* History of bleeding disorder

Primary outcomes:
measure: Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
timeFrame: Baseline, 1st month, 3rd month, 6th month
measure: Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month
timeFrame: Baseline, 1st month, 3rd month, 6th month
measure: Change from baseline SF-36 score at 1-month, 3-month and 6-month
timeFrame: Baseline, 1st month, 3rd month, 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
state: Şişli
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Jülide Öncü Alptekin
role: STUDY_CHAIR
References:
Clinical trial NCT03503331: UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Official title: UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-04-19
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Brain amyloid PET levels will be measured with the PET tracer \[C-11\]PiB in all study participants.
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study.

Detailed description: The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB-ADC cohort. The amount and distribution of \[C-11\]PiB in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from \[C-11\]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.

Eligibility criteria: Inclusion Criteria:

- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).

2. Negative urine or serum B-hCG test within 2 days of \[C-11\]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

1. Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).
2. Inability or contraindication for undergoing MRI and/or PET imaging
3. Inability to participate in the imaging studies due to severity of dementia

Primary outcomes:
measure: Measurement of pathological beta-amyloid in the brain
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jonathan McConathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686031: An Evaluation of Operating Room Staff's Awareness of Environmental Sustainability and Medical Waste Management
Official title: An Evaluation of Operating Room Staff's Awareness of Environmental Sustainability and Medical Waste Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental-Pollution-Related Condition
Keywords: Environment
Inhalational Anaesthetics
Recycling
Global Warming
Carbon Footprint
Operating Room
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anaesthesiologists, surgeons, residents, nurses, cleaning staff and medical students from any gender and age group working in Ankara University.

Brief summary: The main goals of this single-centre cross-sectional study were to measure views on the environmental effects of the operating room and identify the main barriers to recycling in the operating room environment as perceived by the staff. Participants responded a questionnaire to measure their opinions and the views.


Eligibility criteria: Inclusion Criteria:

* all personel working in operating room

Exclusion Criteria:

* missing data

Primary outcomes:
measure: Most reported barriers to recycling
timeFrame: 3 Weeks
measure: Views on the environmental effects of the OR
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: AnkaraU
state: Çankaya
Study officials:
References:
Clinical trial NCT03184831: Comparison of Deproteinized Bovine Bone Mixed With Injectable Platelet Rich Fibrin Versus a Sole Deproteinized Bovine Bone "TUTOGEN BONE" in Sinus Floor Elevation With Simultaneous Implant Placement. A Randomized Clinical Trial
Official title: Comparison of Deproteinized Bovine Bone Mixed With Injectable Platelet Rich Fibrin Versus a Sole Deproteinized Bovine Bone "TUTOGEN BONE" in Sinus Floor Elevation With Simultaneous Implant Placement. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Floor Elevation
Keywords: sinus lift, injectable platelet rich fibrin, sticky bone, bovine bone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 28 recruited patients indicated for sinus floor elevation with simultaneous implant placement . they were divided into two groups. first group was assigned for placement of deproteinized bovine bone solely, while the other group was assigned for the placement of mixture of injectable platelet rich fibrin with deproteinized bovine bone into the sinus after implant placement.


Eligibility criteria: Inclusion Criteria:

Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .

Exclusion Criteria:

1. General contraindications for implant
2. Systemic diseases that might affect the healing of bone
3. Patients with sinus pathology

Primary outcomes:
measure: patient satisfaction
timeFrame: 7 days postoperative
Secondary outcomes:
measure: implant stability
timeFrame: will be measured intraoperatively immediately after insertion of the implant and will be measured one more time 6 months after the first operation at time of implant exposure
measure: height of bone gained around the implant
timeFrame: 6 months postoperative
measure: bone density around the implant
timeFrame: 6 months postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01518231: Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Official title: Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Keywords: stroke
hematopoietic stem cell transplantation
Lead sponsor: Zhejiang Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2012-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

Detailed description: Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Eligibility criteria: Inclusion Criteria:

* aged 40\~70
* no consciousness disorders
* internal carotid artery territory infarction
* stroke happened \< 1 year
* with stable hemiplegia, but remain dependent in daily life
* SSS(Scandinavian Stroke Scale) \< 40

Exclusion Criteria:

* pregnant women
* can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition

Primary outcomes:
measure: Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
timeFrame: 1,3,6,12 months after cell transplantation
Secondary outcomes:
measure: Barthel index
timeFrame: 1,3,6,12 months after cell transplantation
measure: perfusion magnetic resonance imaging scan
timeFrame: 1,3,6,12 months after cell transplantation
measure: Modified Rankin Scale(mRS)
timeFrame: 3,6,12 months after cell transplantation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yaguo Li
state: Zhejiang
Study officials:
affiliation: Zhejiang Hospital
name: Yaguo Li, master
role: STUDY_DIRECTOR
affiliation: Zhejiang Hospital
name: Yumiao Zhou, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552331: Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Official title: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Fractures
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Synthes Canada
name: AO Research Fund
First posted: 2007-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.


Eligibility criteria: Inclusion Criteria:

* The patient has read and agree to the consent
* Patient is 16 years or older (bones have finished growing)
* The injury happened in the last 14 days

Exclusion Criteria:

* The patient taking part in another study
* The patient has an infection at the operative site
* The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
* The patient is taking medication that affects bone healing (such as systemic steroids)
* The patient has malignant (tumor) disease
* The patient is unable to attend follow-up clinic visits

Primary outcomes:
measure: Delayed union or nonunion of the distal femur
timeFrame: 12 months post operative
Secondary outcomes:
measure: Time to clinical healing
timeFrame: 12 months
measure: Function as assessed by patient
timeFrame: 6 months, 12 months
measure: Frequency of adverse events
timeFrame: 12 months
measure: Range of motion
timeFrame: Post-op, 6 weeks, 3 months, 6 months, 12 months
measure: Gait analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Ross K Leighton, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.