louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01229033: Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF
Official title: Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Ablation
Atrial Flutter
Keywords: Atrial fibrillation
ablation
atrial flutter
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
First posted: 2010-10-27
Enrollment: 186
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: Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.

When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.

In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).


Eligibility criteria: Inclusion Criteria:

* Patients (\>=18 und \< 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
* At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
* Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR \> 2..
* Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
* Atrial tachycardia occurring during ablation of CFAE (defined as CL \> 200 msec und stable activation sequence).

Exclusion Criteria:

-

Primary outcomes:
measure: Freedom from atrial tachyarrhythmia
Secondary outcomes:
measure: Procedural and safety data
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
city: München
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Deutsches Herzzentrum München
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum München
name: Clemens Jilek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04814433: Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Official title: A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Opioid Pain Medication
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.

Detailed description: The aim of the study is to provide long term pain relief and decrease the use of postoperative narcotics. All treatments are applied topically to the surgical bed prior to closure of the skin. Each of the drugs used in this study are Food and Drug Administration (FDA) approved and routinely used for pain relief. However, the route of administration of the drugs and addition of tranexamic acid or aminocaproic acid is considered off-label (outside of the FDA-approved indications) and therefore investigational.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Any patient undergoing elective hand surgery

Exclusion Criteria:

* Any patient with a traumatic open wound (only surgically created wounds will be included)
* History of chronic pain
* History of narcotic addiction
* History of recreational drug dependency
* History of psychiatric pathology
* Allergy to local anesthetics, recombinant human thrombin or tranexamic acid
* Any patient receiving a supra/infraclavicular block for anesthesia

Primary outcomes:
measure: Change in Postoperative Pain Control
timeFrame: Day 1 preoperative , Day 14 postoperative
Secondary outcomes:
measure: Amount of Opioid Pain Medication Required Postoperatively
timeFrame: From Day 1 postoperative to Day 14 postoperative
measure: Total Time in Post Anesthesia Care Unit (PACU)
timeFrame: From Day 1 postoperative until discharge from PACU (up to 1 day)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349033: Virtual Human Technology for Patients With Chronic Pain
Official title: Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2020-04-16
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.

Detailed description: Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.

Eligibility criteria: Inclusion Criteria:

* Chronic musculoskeletal Pain

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Pain Intensity
timeFrame: Change from Baseline to 1-month follow-up
Secondary outcomes:
measure: Pain Interference
timeFrame: Change from Baseline to 1-month follow-up
measure: Pain Stages of Change Questionnaire
timeFrame: Change from Baseline to 1-month follow-up
measure: Pain Catastrophizing Scale
timeFrame: Change from Baseline to 1-month follow-up
measure: Emotional Distress
timeFrame: Change from Baseline to 1-month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Center for Self-report Science
state: California
Study officials:
affiliation: University of Southern California
name: Doerte U Junghaenel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Mark A Lumley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023033: Supporting Attendance for Facility Delivery and Infant Health
Official title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Keywords: PMTCT
MNCH
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Population Council
name: Ministry of Health, Tanzania
First posted: 2017-01-18
Enrollment: 1505
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.

Detailed description: Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, \[mobile health or mhealth\] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).

Eligibility criteria: Inclusion Criteria:

* Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
* Plans to deliver in facility catchment area
* 18 years or older
* Able and willing to provide consent

Exclusion Criteria:

-

Primary outcomes:
measure: Attendance for Early infant diagnosis (EID) of HIV
timeFrame: 1 year
measure: Early identification of HEI at Reproductive and Child Health (RCH) Clinic
timeFrame: 1 year
measure: Antenatal care (ANC) visits
timeFrame: 1 year
measure: Facility delivery
timeFrame: 1 year
measure: Post natal care (PNC) visits
timeFrame: 1 year
measure: Nevirapine (NVP) at delivery
timeFrame: 1 year
Secondary outcomes:
measure: Receipt of EID results
timeFrame: 1 year
measure: HIV infected infants initiated on antiretroviral therapy (ART)
timeFrame: 1 year
measure: Time to EID
timeFrame: 1 year
measure: Time to receipt of EID results
timeFrame: 1 year
measure: Time to treatment
timeFrame: ! year
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey Woelk, MCOMMH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
Clinical trial NCT00079833: Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Official title: A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Zollinger-Ellison Syndrome
Keywords: gastric acid hypersecretory conditions
Idiopathic Hypersecretion
Excessive Gastric Acid secretion
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age.
* Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion

Exclusion Criteria:

* Pregnant or lactating females
* History of drug addiction or alcohol abuse within 12 months prior to Screening.
* History of intolerance to any proton pump inhibitors or any ingredient in their formulation.

Primary outcomes:
measure: To assess the gastric acid secretory rate at the final study visit.
measure: Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery
Secondary outcomes:
measure: The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
measure: Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.
measure: The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: King of Prussia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Clichy
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint Germain en Laye
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04047433: The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
Official title: The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery, Obstetric
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms -

1. with external anal sphincter injury
2. without injury both will go through genetic screening test the arm with the external anal sphincter injury will also be tested for advanced genetic testing
Primary purpose: SCREENING

Brief summary: Single-nucleotide polymorphisms (SNP's) in connective tissue components are associated with increased risk of pelvic organ prolapse (POP). The investigators expect to find a difference in SNP's frequency between women who had Obstetric anal sphincter injuries (OASIS) and in the healthy population. The fact that pelvic organ prolapse (POP) and OASIS occurs in the same anatomic region and the well-known association between few SNP's and the risk for POP, suggests for a common pathophysiology.

Detailed description: The perineum consists of skin, muscles and connective tissue. A connective tissue disorder related to POP has been reported in biochemical and molecular studies. OASIS are considered a severe complication of vaginal delivery that may lead to a great deal of morbidity. Familial history is known as a risk factor for OASIS. Currently, there is no established genetic link between connective tissue components and OASIS. Therefore, the investigators assume that studying the genetic predisposition factors of women who experience OASIS, might generate a stronger tool to predict severe occurrence of vaginal laceration. It may also help to consult women before vaginal delivery about the risk of OASIS.

The aim of this study is to find an association between genetic variation and increased risk for OASIS.

Eligibility criteria: Inclusion Criteria:

* Women with severe external anal sphincter injury during first vaginal delivery
* Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration

Exclusion Criteria:

* Women with known metabolic or connective-tissue disorder (e.g., Ehlers-Danlos syndrome).
* Women with known neurologic disorder
* Women undergoing episiotomy cut or assisted delivery (e.g., vacuum or forceps delivery)

Primary outcomes:
measure: difference in the frequency of of Single-nucleotide polymorphisms
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: genetic mutation
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Hedi Raischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03569033: Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
Official title: A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Cough
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).


Eligibility criteria: Inclusion Criteria:

* In good general health
* Susceptible to human rhinovirus type 16 (HRV-16)
* Male or non-pregnant and non-breast feeding female
* If female of reproductive potential, agrees to use 1 form of acceptable birth control

Exclusion Criteria:

* Donated blood within 56 days or donated plasma within 7 days prior to dosing
* History of significant multiple and/or severe allergies
* Recent history of respiratory tract infection
* History of cancer
* Body mass index \<18 kg/m\^2 or ≥40 kg/m\^2
* History of major surgery or loss of 1 unit of blood
* History of allergic reaction to sulfonamides
* Received medications within 14 days prior to randomization
* Significantly abnormal laboratory tests at Screening
* Current smoker, smoked within 5 years of Screening, or significant past smoking history
* History of alcohol or drug abuse

Primary outcomes:
measure: Awake Coughs Per Hour on Day 3
timeFrame: Day 3
Secondary outcomes:
measure: Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
timeFrame: Baseline and Day 3
measure: Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
timeFrame: Baseline and Day 3
measure: Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
timeFrame: Baseline and Day 3
measure: Percentage of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to 21 days
measure: Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.
Clinical trial NCT00480233: Screening Questionnaire for Depression
Official title: Validation of a Hebrew Version of a Brief Screening Questionnaire for Depression in General Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: depression
screening
primary care
validity
Hebrew
Primary care and general medical patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care and general medical patients

Brief summary: Depression is common in primary care and general medical settings, but is often unrecognized and untreated by physicians working in those settings.

The Patient Health Questionnaire for depression (PHQ-9) is well validated and widely used screening instrument.


Eligibility criteria: Inclusion Criteria:

* \>18 yrs
* Primary care and general medical patients
* Understand the IC
* Speaks Hebrew
* No significant cognitive impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center and Maccabi Health Services
Study officials:
affiliation: The Gertner Institute
name: Raz Gross, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04649333: COVID-19 and Sports - an Online Survey on the Impact of the Pandemic and Possible Preventive Measures
Official title: COVID-19 and Sports - an Online Survey on the Impact of the Pandemic and Possible Preventive Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Universitaet Innsbruck
First posted: 2020-12-02
Enrollment: 1336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey was shared and promoted by the participating universities, some sport organisations and administrators, and by multiple medical colleagues and athletes.

Brief summary: Aim of the study was to investigate the effects of the COVID-19 pandemic on individual and general sport activities in an effort to provide information for safe return to community sports.


Eligibility criteria: Inclusion Criteria:

-Age over 18 years

Exclusion Criteria:

* age under 18 years

Primary outcomes:
measure: The type, extent and intensity of physical activity
timeFrame: 10 to15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References: