louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04544397: Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Official title: Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Atrial Fibrillation Paroxysmal
Atrial Fibrillation, Persistent
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>/= 18 years, with paroxysmal or persistent AF, that met the indications provided by international guidelines to undergo catheter ablation for AF as standard of care.

Brief summary: The purpose of this study is to collect data on laser ballon (2nd gen) systems for catheter ablation for AF, in order to determine the safety and the efficacy of this technique.

Moreover, the investigators aim to determine the short and long term outcomes of pulmonary vein isolation evaluating arrhythmia recurrence, especially using continuous rhythm monitoring with implantable loop recorders (ILR).

Detailed description: LIGHT-AF is an observational, multicentric study designed to collect pre-procedural, procedural and follow-up data of consecutive patients that underwent catheter ablation for AF with laser ballon (2nd gen system). A number of 3 enrolling centers is estimated with an overall number of about 100 patients. A minimal follow-up of 3 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term recurrence of AF, evaluated with intracardiac rhythm monitoring.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Patients with paroxysmal, persistent or long-standing persistent AF
* Patients able to provide written informed consent or have informed consent as provided by a legal representative

Exclusion Criteria:

* Age \< 18 years
* Patients unable or unwilling to receive oral anticoagulation

Primary outcomes:
measure: AF recurrences
timeFrame: 2 years
Secondary outcomes:
measure: Arrhythmia burden
timeFrame: 2 years
measure: Redo ablation procedures
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
city: Milan
country: Italy
facility: Ospedale Luigi Sacco - Polo Universitario
state: Mi
city: Monza
country: Italy
facility: Ospedale San Gerardo - ASST Monza
Study officials:
References:
Clinical trial NCT03007797: Realization of the Recommendation for Influenza Vaccination in Pregnant Women
Official title: Women - Influencing Factors and Coverage Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coverage Rate of Vaccination for Influenza
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: Klinikum Worms
First posted: 2017-01-02
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 236 pregnant women in 2 centers

Brief summary: Introduction:

In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors.

Method:

A cross-sectional study was realized at two Level 1 perinatal centers in two German federal states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed by using a standardized and pre-tested questionnaire covering their knowledge about the influenza vaccination and other factors influencing the vaccination decision. Furthermore, data from the vaccination card and the pregnancy record booklet have been evaluated.


Eligibility criteria: Inclusion Criteria:

* pregnant women older than 18
* vaccination records
* signatetd letter of agreement

Exclusion Criteria:

* younger than 18

Primary outcomes:
measure: Influenza Vaccination rate in Pregnant Women
timeFrame: 02/12- 02/14
Secondary outcomes:
measure: influencing factors on the Influenza vaccination rate
timeFrame: 02/12- 02/14
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00702897: Ambulatory Surgery of Lower Extremity Varicose Vein
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed.

Brief summary: OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese patients with primary varicosities of the lower extremities including the use of endovenous laser, phlebectomy, and sclerotherapy.

METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the application of endovenous laser. Vein access was achieved by either a percutaneous or stab wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10 cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were prominent branch varicosities. We instructed each patient to walk around immediately after the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.


Eligibility criteria: Inclusion Criteria:

* All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed

Exclusion Criteria:

* poor general health, inability to walk, active inflammation of varicose veins, deep venous occlusion disease, hypercoagulability, pregnancy and breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT04818697: Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic
Official title: Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rhythm Disorder
Covid19
Social Isolation
Keywords: Heart Rhythm Disorder
Physical Activity
Kinesophobia
Health Literacy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy individuals 18 years old and older, who are diagnosed with heart rhythm disorders, and whose local language is Turkish will be included in the study.

Brief summary: The aim of our study is to examine the effect of social isolation on physical activity level, health literacy and kinesophobia in heart rhythm disorders.

Detailed description: To prevent the spread of COVID-19, states are imposing quarantine measures and sanctions for all citizens to stay at home as much as possible. These measures severely limit physical activity. It is known that physical activity is an important preventive approach for many preventable diseases, especially cardiovascular diseases. Restriction of physical activity, loss of usual routine, and reduced social and physical contact with others can cause feelings of distress, disappointment, and isolation.

In the latest guidelines, increasing physical activity is recommended to prevent heart rhythm disorders and contribute to the effectiveness of treatment.

The aim of our study is to examine the effect of social isolation on physical activity level, health literacy, and kinesophobia in heart rhythm disorders.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with heart rhythm disorders
* Being clinically stable
* To comply with social isolation rules
* Volunteering to participate in the research

Exclusion Criteria:

* Having a cognitive problem
* Not being literate

Primary outcomes:
measure: Physical Activity Level
timeFrame: June 2020-March 2021
measure: Fear of Movement
timeFrame: June 2020-March 2021
Secondary outcomes:
measure: Health Literacy
timeFrame: June 2020-March 2021
measure: Weekly Average of Steps
timeFrame: June 2020-March 2021
measure: Weekly Average of Going Outside
timeFrame: June 2020-March 2021
measure: The Comorbid Conditions
timeFrame: June 2020-March 2021
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hikmet Yorgun, PhD MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, PhD MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Dilara Saklıca, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05239897: Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation
Official title: Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

Detailed description: Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS) was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network. Therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether cTBS can cure POD in this senior patient population.

Eligibility criteria: Inclusion Criteria:

* Aged between 60 to 80 years;
* Having delirium after elective surgery;
* Being able to complete cognitive assessment and confusion assessment methods (CAM);
* Willing to participate before surgery and being competent to provide informed consent.

Exclusion Criteria:

* Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);
* Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);
* Participating in other clinical studies.

Primary outcomes:
measure: Cure rate of POD after a single cTBS treatment
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Cure rate of POD after multiple cTBS treatments
timeFrame: 7 days after surgery
measure: Severity of postoperative delirium changed after each cTBS treatment
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Pudong
country: China
facility: Renji hospital, School of medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References:
Clinical trial NCT00034697: Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)
Official title: A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastases, Neoplasm
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Keywords: Brain mets
non-small cell lung cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-02
Enrollment: 24
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: Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic confirmation of non-small-cell lung cancer
* Stable systemic disease
* Maximum of one prior chemotherapy regimen for metastatic systemic disease
* Radiotherapy for local control or palliative bony lesions is allowed
* Karnofsky of greater than or equal to 70%
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Patients eligible for surgery of the brain
* Any previous chemotherapy for the brain metastasis
* Chemotherapy within 4 weeks or previous temozolomide
* Prior radiotherapy to the brain
* Radiation therapy to greater than 50% of the bone marrow
* Insufficient recovery from previous therapies
* Active nonmalignant systemic disease
* Inability to take oral medication
* Pregnant or nursing women
* Non use of adequate contraceptive techniques, negative urine pregnancy test is required
* Known AIDS related illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00042497: Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Official title: A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Anosys
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma


Eligibility criteria: * Patients with Stage IV metastatic melanoma with 0-1 prior treatments for metastatic disease.
* All patients must have distant skin, subcutaneous, or nodal metastases (M1a) or lung metastases (M1b), measurable disease, normal lactate dehydrogenase levels, and HLA type A1, A2, or B35.
* Patients must have adequate organ function and an estimated life expectancy of at least 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05230797: Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Versus Zinc Oxide- Eugenol as Obturating Material in Primary Teeth Pulpectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pulp Necroses
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial aims to evaluate the clinical and radiographic success of Zinc oxide- propolis versus Zinc oxide -Eugenol as obturating material in pulpectomy of non-vital primary teeth.

Detailed description: Pulpectomy is considered the most convenient way to treat the non-vital primary teeth as it preserves the affected tooth to maintain the length and integrity of the dental arch until exfoliation4. Zinc oxide-eugenol cement (ZOE) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. Concerns about these drawbacks of ZOE directed to search for alternative obturating materials for primary teeth.

Propolis, a natural resinous substance, is collected by honey bees with potent antimicrobial and anti-inflammatory properties. The main chemical constituents present in propolis are flavonoids, phenolics, and other aromatic compounds. Considering these beneficial effects of propolis, a zinc oxide-propolis mixture is suggested to increase the survival rate and improve the treatment prognosis of non-vital primary teeth.

Eligibility criteria: Inclusion Criteria:

* Children 4-6 years
* Non-vital primary molars
* Teeth with radiographic evidence of minimum bone loss.

Exclusion Criteria:

* Primary molars with less than two-thirds of the remaining root length
* Molars demonstrating extensive external or internal resorption,
* Teeth exhibiting greater than Grade I mobility
* Non-restorable with stainless steel
* Children whose parents or caregivers did not give consent for the study

Primary outcomes:
measure: Absence of Pain
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02947997: Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning
Official title: Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.

Detailed description: 10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Eligibility criteria: Inclusion Criteria:

* Subjects must be over the age of 18
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects with the inability to swallow pills and capsules.
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Subjects who have a bleeding disorder and are currently on anti-coagulants.

Primary outcomes:
measure: Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule
timeFrame: Approximate 20 minute visit (5 min image acquisition)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03945097: University of Washington Reading & Dyslexia Research Program
Official title: University of Washington Reading & Dyslexia Research Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reading Disability
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-05-10
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 72
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Typically developing children

Brief summary: Subjects are recruited for a pre-kindergarten education program focusing on early literacy skills. Primary outcomes are improvement in letter knowledge and changes in brain response to text.


Eligibility criteria: Inclusion Criteria: Typically developing children enrolled before kindergarten.

* Typically developing child between 60 and 72 months of age
* Has not yet begun Kindergarten

Exclusion Criteria:

* Reported neurological or psychiatric condition.
* Claustrophobia. ADHD

Primary outcomes:
measure: Letter Knowledge
timeFrame: Within 2 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washignton
state: Washington
Study officials:
affiliation: University of Washington
name: Jason Yeatman, PhD
role: PRINCIPAL_INVESTIGATOR
References: