louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05707936: Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath
Official title: Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Port-a-cath Occlusion
Normal Saline
Heparin Lock
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Purpose:

An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial

Method:

This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation.

We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.


Eligibility criteria: Inclusion Criteria:

Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization.

Exclusion Criteria:

History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

Primary outcomes:
measure: port-a-cath occlusion
timeFrame: in hospitalized (during admission), up to 12 weeks
measure: port-a-cath infection
timeFrame: in hospitalized (during admission), up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02929836: Catheter Ablation of Longstanding Persistent Atrial Fibrillation
Official title: Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Ablation Linear Lesions
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.

Detailed description: Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.

Eligibility criteria: Inclusion Criteria:

* Patients with longstanding persistent atrial fibrillation (lasting for\>1 year)
* Exhibited refractoriness to at least one antiarrhythmic drug
* Left atrial diameter \<=60mm

Exclusion Criteria:

* Patients with uncontrolled congestive heart failure
* Having significant valvular disease and/or prosthetic heart valve(s)
* With myocardial infarction or stroke within 6 months of screening
* With Significant congenital heart disease;ejection fraction was \<40% measured by echocardiography
* Allergic to contrast media
* Contraindication to warfarin or heparin
* Severe pulmonary disease e.g. restrictive pulmonary disease
* Chronic obstructive disease (COPD)
* Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography
* Having any contraindication to right or left sided heart catheterization
* Poor general health
* Life expectancy less than 6 months

Primary outcomes:
measure: Time to first documented recurrence of atrial arrhythmias
timeFrame: 2-year follow-up
Secondary outcomes:
measure: Procedure duration at ablation
timeFrame: At the end of the first ablation procedure
measure: Ablation time at ablation
timeFrame: At the end of the first ablation procedure ]
measure: Fluoroscopy time at ablation
timeFrame: At the end of the first ablation procedure
measure: Complications
timeFrame: 2-year follow-up
measure: Type of recurrent arrhythmia
timeFrame: 2-year follow-up
measure: Number of redo procedures
timeFrame: 2-year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai chest hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Xu Mr Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00528736: Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Ductus Arteriosus, Patent
Natriuretic Peptide Brain
Keywords: preterm infants < 28 weeks
B-type natriuretic peptide
prediction
ductus intervention
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 82
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The aim of the study was to evaluate BNP in preterm infants \< 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

Detailed description: From the study infants blood samples (0.1ml) were collected in K-EDTA microtubes within 24 to 48 hours of age through umbilical artery catheter aspiration or routine venous puncture. The samples were spun at 7000 rpm for 3 minutes. Platelet-free plasma was stored at -20°C until BNP analysis of all collected samples was carried out. The BNP assay was performed using a fully automated immunoassay system ADVIA method for the Centaur System (Bayer Diagnostic Division).

In preterm infants who were treated with indomethacin or surgical ligation we collected additional blood samples 2-4 hours before intervention and 24 hours after the completion of the ductus treatment.

Eligibility criteria: Inclusion Criteria:

* Written parental informed consent
* Preterm infant \< 28 weeks of gestation
* Admitted to our NICU within 48 hours after birth

Exclusion Criteria:

* No written parental informed consent,
* Congenital heart disease,
* Death

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neonatology, Charite Virchow Hospital, Medical University Berlin
Study officials:
affiliation: Department of Neonatology, Charite Virchow Hospital, Medical University Berlin
name: Christoph Czernik, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06653036: Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion
Official title: Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality Health Care
Keywords: Quality Labor Analgesia
Maternal Adverse Events
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are

* Effectiveness and quality of labor analgesia
* Frequency of catheter adjustments
* Need for catheter replacements
* Incidence of failed regional anesthesia requiring conversion to general anesthesia


Eligibility criteria: Inclusion Criteria:

* Nulliparous / Multiparous women
* Age \>18 years
* ASA 1 \& 2
* Singleton vertex presentation
* Gestational age 37-42 weeks
* Parturient with established labor and pain score ≥ 3

Exclusion Criteria:

* Major cardiac disease
* History of chronic pain
* Chronic opioid user
* Platelet count \< 70 x 109/L
* spinal cord anomalies
* Use of anticoagulants
* Allergic to local anesthetics
* Patients with preeclampsia/ eclampsia
* Known fetal anomalies

Primary outcomes:
measure: Pain Assessment
timeFrame: At 30 minutes of initiation of infusion
measure: Need for catheter adjustment
timeFrame: At 30 minutes of initiation of infusion
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: At 30 minutes of initiation of infusion
measure: Assessment of the level of motor Block
timeFrame: At 30 minutes after the initiation of infusion
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
References:
Clinical trial NCT03854136: Treatment and Complications of Musculoskeletal Tumors
Official title: Treatment and Complications of Musculoskeletal Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Diseases or Conditions
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of all ages and gender who underwent surgical intervention for musculoskeletal tumors at our institution were included

Brief summary: Patients being treated for musculoskeletal tumors were included in the study. Their records were reviewed retrospectively and data was gathered regarding types of surgeries and post-operative complications including recurrence or development of secondary tumors if any.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing treatment for musculoskeletal tumors

Exclusion Criteria:

* Patients who did not undergo any surgical intervention

Primary outcomes:
measure: Recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Obada Hassan, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499836: Quality Study of Anesthetic Technique on Breast Cancer Surgery
Official title: Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Quality of Recovery
Satisfaction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 101
Sex: FEMALE
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: Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patient has a physical status between ASA I and III
* Female
* 18 - 70 years of age
* Patients able to read a newspaper in Chinese.
* Elective unilateral wide excision/simple mastectomy and SLNB/ALND
* Patient has signed an informed consent
* Without contraindication of GA or PVB
* Body mass index (BMI) less than 24 kg/m2

Exclusion Criteria:

* ASA \> III
* inability to provide informed consent
* Bleeding disorders
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
* Allergy to amide-type local anesthetics or NSAIDs
* Infection at the thoracic paravertebral injection site
* Pregnancy or breast-feeding
* Severe spine or chest wall deformity
* body mass index equal to or more than 24 kg/m2
* patients with major psychosis or drug and alcohol abuse
* patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
* Patients with significant visual impairment or other physical disability that precludes complete cooperation

Primary outcomes:
measure: quality of recovery
timeFrame: postoperative 6 hour and postoperative day(POD)1
Secondary outcomes:
measure: adverse events
timeFrame: POD1
measure: Number of patients with a technique failure of the PVB
timeFrame: during operation
measure: NRS pain score
timeFrame: postoperative 1 hour, 6 hour, and POD1
measure: Satisfaction
timeFrame: POD1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
Study officials:
affiliation: Koo Foundation Sun Yat-Sen Cancer Center
name: Nai Liang Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433636: Mindful Waiting Room
Official title: Idle Waiting or Meditating: Does a Brief, Mindfulness Intervention in the Clinic Waiting Room Improve Patient Outcomes?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety State
Depressive State
Pain
Nausea
Fatigue
Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare.

A secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain.


Eligibility criteria: Inclusion Criteria:

* Seeking treatment at the Huntsman Cancer Institute's Wellness Center
* Adults 18+
* Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures
* An unstable illness judged by medical staff to interfere with study treatment

Primary outcomes:
measure: Acceptability
timeFrame: A single 5-minute period
Secondary outcomes:
measure: Change in Pain
timeFrame: Immediately before to after 5-minute audio recording
measure: Change in Anxiety
timeFrame: Immediately before to after 5-minute audio recording
measure: Change in Depression
timeFrame: Immediately before to after 5-minute audio recording
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT02022436: Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Official title: Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-12-27
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.

Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.

Detailed description: Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.

Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.

Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
* 21 years of age or older
* ability to give informed consent.

Exclusion Criteria:

* Inability to provide an informed consent
* Known allergy to Definity
* Unstable cardiopulmonary conditions
* pregnancy

Primary outcomes:
measure: Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake
timeFrame: Up to 5 years or time of aneurysm repair surgery.
measure: Number of Participants With Microbubble Uptake
timeFrame: At the first follow-up evaluation at 6 months
Secondary outcomes:
measure: Mean Value of Systemic Inflammatory Serum Biomarkers
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Division of Vascular Surgery
state: Pennsylvania
Study officials:
affiliation: UPMC UPP
name: Rabih Chaer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717936: Investigation of Desmoplastic Squamous Cell Carcinoma
Official title: Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of the Skin
Keywords: squamous cell carcinoma
dermatosurgery
immunohistochemistry
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H\&E staining. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.


Eligibility criteria: Inclusion Criteria:

* desmoplastic squamous cell carcinoma (SCC) of the skin

Exclusion Criteria:

* tumor recurrence
* collision tumors
* other skin malignancies
* progeria
* Rothmund-Thomson-Syndrome
* lacking of the capacity for informed consent

Primary outcomes:
measure: Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .
timeFrame: 4 years
Secondary outcomes:
measure: Reduction of local recurrence with immunohistochemistry
timeFrame: 4 years
measure: Histological pattern of tumour growth (continuous versus discontinuous)
timeFrame: 4 years
measure: Dimension of the tumor spreading according to histological work-up (measured in mm)
timeFrame: 4 years
measure: Presence of perineurial and perivascular tumor invasion according to histological work-up
timeFrame: 4 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universityhospital
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT05037136: Remote Monitoring of AF Recurrence Using mHealth Technology
Official title: Remote Monitoring of AF Recurrence Using mHealth Technology (REMOTE-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long Standing Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Digital health
Artificial intelligence
Catheter ablation
Thoracoscopic surgical AF ablation
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2021-09-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with long standing persistent atrial fibrillation who have undergone an ablative procedure for the condition and who were implanted with a loop recorder to monitor their heart rhythm as part of their participation in LoTO in CASA LSPAF (NCT04280042)

Brief summary: Atrial fibrillation (AF) is the most common arrhythmia worldwide. It carries a significant health burden, conferring on sufferers a reduction in quality of life, risk of significant morbidities such as stroke and heart failure, and significant mortality. At present, diagnosis of AF involves referral for conventional 12 lead electrocardiogram (ECG) recording, ambulatory ECG for fixed time period recording, or insertion of implantable loop recorders (ILR). These investigations are limited both by recording only at specific time points and failing to explore the interaction between heart rate and day-to-day physical activity. In recent years, the use of mobile health (mHealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. From a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solution to identify and possibly predict AF. In this study, the investigators propose to recruit participants who have undergone an ablative procedure as part of a randomised clinical trial (LoTO in CASA LSPAF: NCT04280042) and monitor for recurrence of AF using mHealth technology by correlating with ILR data.


Eligibility criteria: Inclusion Criteria:

* Participants in LoTO in CASA LSPAF with implanted loop recorders (ILR)

Exclusion Criteria:

* Participants in LoTO in CASA LSPAF who had their ILR explanted

Primary outcomes:
measure: To explore if mHealth obtained heart rate (PPG) data can be correlated to recurrence of AF/AT in patients who have undergone an ablative procedure.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust
Study officials:
affiliation: Royal Brompton & Harefield Hospitals, GSTT NHS Foundation Trust
name: Shouvik Haldar
role: PRINCIPAL_INVESTIGATOR
References: