louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01090401: Linox Smart S DX PME/Master Study
Official title: PME/Master Study of the Linoxsmart S DX ICD Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ICD Indication
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.


Eligibility criteria: Inclusion Criteria:

* Patients with standard ICD indication
* Be available for follow-up visits on a regular basis at an approved investigational center

Exclusion Criteria:

* Patients with standard ICD contra-indication
* Patients with permanent atrial fibrillation
* Have a life expectancy of less than six months
* Are expecting to receive cardiac surgery within 6 months after enrollment
* Age \< 18 years
* Not enrolled in another cardiac clinical investigation

Primary outcomes:
measure: Rate of atrial adequate sensing
timeFrame: 6 months
Secondary outcomes:
measure: Linox smart S DX related complication-free rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital Benjamin Franklin
Study officials:
References:
Clinical trial NCT04765501: Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire
Official title: Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Headache Disorders
Headache, Migraine
Headache, Tension
Headaches Chronic
Headaches Muscular
Keywords: Headache
Reliability
Validity
Cross-cultural adaptation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals with any type of headache.

Brief summary: The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ).

Detailed description: The episodic nature of migraine attacks presents a number of difficulties in characterizing disease severity. There are differences in the severity, frequency and intensity of attacks and the general effect of the disease in individuals. Information about any particular attack is not sufficient to characterize the overall severity of the disease. Accordingly, the Headache Impact Questionnaire (HIQ) was developed to evaluate the headache experience over a period of time instead of any headache. Developed to measure the impact and quality of life of individuals suffering from headache, hıq evaluates the frequency and duration of headache, the degree of pain severity, daily life activities, disruptions in work or school life, the influence of the individual's leisure activities and other symptoms that may occur. HIQ consists of 16 items and the higher the score shows the seriousness of the impact. The study is planned with 80 individuals with complaint of headache. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in HIQ, Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and Short Form-36.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with any type of headache,
* Have a chronic headache.

Exclusion Criteria:

* Having a cognitive and neurological disorders.

Primary outcomes:
measure: Headache Impact Questionnaire (HIQ)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Halime ARIKAN
state: None Selected
Study officials:
References:
Clinical trial NCT03582501: Measurement of Hemodynamic Responses to Lower Body Negative Pressure
Official title: Physiology of the Early Stage of Hemorrhage and Early Identification of Progression Toward Hemodynamic Instability in Humans for Validation of Current Machine Learning Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension and Shock
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hypovolemia by analyzing the arterial waveforms collected during LBNP.

Detailed description: Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Eligibility criteria: Inclusion criteria:

18-55 year of age Non-smoker No history of hypertension No history of diabetes No history of coronary artery disease No history of neurologic disease

Exclusion criteria Prescribed medications other than birth control Inability to lie flat for two hours BMI \> 30 kg/m2

Primary outcomes:
measure: Blood pressure
timeFrame: One day of study visit
Secondary outcomes:
measure: Heart rate
timeFrame: One day of study visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Timothy B Curry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896401: InSeal Vascular Closure Device Clinical Study Protocol
Official title: InSeal Vascular Closure Device Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Percutaneous Closure of Artery Access Sites
Keywords: large bore endovascular catheterization procedures
Vascular Closure Device
Lead sponsor: InSeal Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.

The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.


Eligibility criteria: Inclusion Criteria:

* Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
* Subject age is at least 18 years
* Patient has signed most recent approved version of the Informed Consent
* Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion Criteria:

* Women Of Child Bearing Potential (WOCBP)
* Legally non-competent patients
* Patient participating in another clinical study at the time of the InSeal VCD study
* Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
* Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
* Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
* Prior vascular surgery or vascular graft in region of access site
* Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device

Primary outcomes:
measure: 1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
timeFrame: 15 minutes
Secondary outcomes:
measure: 2. Combined rate of closure-device related major adverse events in first month
timeFrame: 1 month
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Cardio Vascular Centrum Frankfurt
Study officials:
References:
Clinical trial NCT05617001: Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Official title: Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 200
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: AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed a new device: Kardia 12L to record 12-lead ECGs. However, the data generated from the new device has not yet been validated for accuracy. The specific aim of this study is to evaluate the accuracy and safety of the AC 12L ECG System. The ECGs collected by the AC 12L ECG System will be compared to simultaneous standard- of-care 12-lead ECG, recorded using the GE CardioSoft 12-lead ECG System. The ECGs will be analyzed for accuracy based on statistical difference using root-mean-square error, and cross correlation between the simultaneous 10 second recordings as well as the median beats of all 12 leads.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 years or older
* Ability to remain supine for a conventional 12 lead AliveCor 12L ECG recording for approximately 15 minutes

Exclusion Criteria:

* Open chest wounds or recent (\<30 days) surgery to the chest or abdomen
* Absence of any limb that would require modification of the lead set-up

Primary outcomes:
measure: Agreement on QRS width between Kardia 12L and ECG
timeFrame: 30 seconds
measure: Agreement on PR interval between Kardia 12L and ECG
timeFrame: 30 seconds
measure: Agreement on AT interval between Kardia 12L and ECG
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stavros Stavrakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234801: Retrospective Foot and Ankle Data Collection
Official title: A Retrospective Data Collection Study of the Internal Fixation and Reconstruction of Bones in the Foot & Ankle Using Various Devices: DARCO Heads; CROSS CHECK 3Di; OrthoLoc 3Di
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limb Surgery
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2022-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.

Brief summary: A retrospective post-market data collection study of the following implant devices :

* DARCO™ Headed Cannulated Screw
* ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
* ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

Detailed description: A retrospective post-market data collection study designed to collect safety and performance Standard of Care data on patients who have undergone routine lower limb surgery that involved one of the following implant devices as per the indication for use:

* DARCO™ Headed Cannulated Screw
* ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
* ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

Eligibility criteria: Inclusion Criteria:

Patients 18 years or older at the time of index procedure

• Patients who previously received:

* the Charlotte™ MUC Screw System in accordance with the indications for use: for fixation of bone fractures or for bone reconstruction.
* the CROSSCHECKTM in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
* the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
* a DARCO™ Headed Cannulated Screw in accordance with the indications for use: for bone fracture fixation and bone fragment fixation.

Exclusion Criteria:

* None

Primary outcomes:
measure: To demonstrate the performance of the devices concerned.
timeFrame: 1 year.
measure: To demonstrate the safety of the devices concerned.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
state: Shropshire
Study officials:
affiliation: Robert Jones and Agnes Hunt Orthopaedic Hospital
name: Andrew Bing, FRCS
role: STUDY_CHAIR
References:
Clinical trial NCT04859101: Post-operative Sore Throat and Gum Chewing
Official title: Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.

Detailed description: Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Eligibility criteria: Inclusion Criteria:

* Outpatient ambulatory surgery
* General anesthesia utilizing a laryngeal mask airway
* Greater than 1 hour duration

Exclusion Criteria:

* Chronic laryngitis
* Chronic bronchitis
* Asthma
* Gastroesophageal reflux disease
* Smoking within the last week
* Non-English speaking

Primary outcomes:
measure: Incidence of moderate to severe Post-operative Sore Throat within 24 hours
timeFrame: 24 hour
Secondary outcomes:
measure: Satisfaction with Anesthesia
timeFrame: 24 hour
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jacob L Hutchins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00227201: The Association Between the Use of Complementary and Alternative Medicine and Medication Adherence in Hypertensive African-Americans
Official title: The Association Between the Use of Complementary and Alternative Medicine and Medication Adherence in Hypertensive African-Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: African-American
Hypertension
Complementary medicine
Medication adherence
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The objective of this study is to better understand strategies used by African Americans with hypertension in order to control their blood pressure.

Detailed description: The objective of this study is to better understand strategies used by African Americans with hypertension in order to control their blood pressure. Through the use of qualitative interviews, the beliefs and attitudes toward complementary medicine of African Americans with hypertension will be elucidated.

Eligibility criteria: Inclusion Criteria:

1. Patients will be African-American adults 18 years or older who were diagnosed with poorly controlled hypertension as defined by the 6th Joint National Committee guidelines (systolic \>140 and diastolic \>90).
2. Patients will also be eligible if they are taking any prescribed anti-hypertensive medications.
3. Patients must be able to provide informed consent in English. Participants will be recruited from Cornell Internal Medicine Associates, the primary care and general medicine practice at Cornell Medical Center, the same site as the parent grant.

Exclusion Criteria:

1. Patients who refused to participate.
2. Patients who are unable to provide informed consent.

Primary outcomes:
measure: The impact of positive affect induction and self-affirmation on medication adherence and blood pressure control.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jason Moore
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: JA Moore, Factors that influenced medication adherence among African-Americans with hypertension, to be presented at the 12th Annual NHLBI Cardiovascular Minority Research Supplement Awardee Session, American Heart Association, November 2004.
Clinical trial NCT03793101: Biaxial Microincision Cataract Surgery Technique
Official title: Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract Senile
Keywords: BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,
Lead sponsor: Eyemed Centrum Okulistyczne
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.

Detailed description: Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.

Eligibility criteria: Inclusion Criteria:

1.Clinical diagnose of senile cataract.

Exclusion Criteria:

1. Eye trauma in anamnesis.
2. Eye surgery in anamnesis.
3. Corneal surgery in anamnesis.
4. Corneal irregular astigmatism.
5. Corneal ectasia.

Primary outcomes:
measure: Visual acuity
timeFrame: 3 months
Secondary outcomes:
measure: Keratometry
timeFrame: 3 months
measure: Surgically Induced Astigmatism, SIA
timeFrame: 3 months
measure: Higher Order Aberrations, HOAs
timeFrame: 3 months
measure: Corneal Incision thickness
timeFrame: 3 nmonths
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Eyemed Centrum Okulistyczne
Study officials:
affiliation: Eyemed Centrum Okulistyczne
name: Paweł Klonowski, MD
role: PRINCIPAL_INVESTIGATOR
References: