louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04550325: Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
Official title: A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Pneumonia, Viral
Lead sponsor: Kamada, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Phase 1/2 Open Label, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients with Pneumonia
Primary purpose: TREATMENT

Brief summary: Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR)
3. Hospitalized for COVID-19 pneumonia
4. Dosing should be within 10 days of symptom start
5. Able and willing to sign informed consent form

Exclusion Criteria:

1. History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (\< 7 mg/dL)
2. Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
3. Cardiovascular instability
4. History of thrombo-embolic events
5. Acute renal failure or creatinine \>2 mg/dL or estimated estimated glomerular filtration rate (eGFR) \<30 mL/min
6. History of lung transplantation
7. Major surgery (abdominal and chest) within the last 4 weeks
8. Severe chronic background disease, per investigator's judgement for example, Cirrhosis grade C, Dialysis, cardiac insufficiency (NYHA III), pulmonary disease (FEV1\<50 percent of predicted) etc.
9. Pregnancy or lactation
10. Treatment with plasma units or immunoglobulin preparations within the last 4 weeks
11. Participation in another pharmaceutical interventional clinical study within 4 weeks from screening

Primary outcomes:
measure: Adverse events, serious adverse events, and deaths
timeFrame: 14 days
measure: Adverse events, serious adverse events, and deaths
timeFrame: 28 days
Secondary outcomes:
measure: AUC0-7 of Anti SARS CoV-2 antibodies
timeFrame: 7 days
measure: Neutralization activity
timeFrame: 7 days
Other outcomes:
measure: Duration of Hospitalization
timeFrame: 84 days
measure: Clinical status on the 6 point ordinate scale
timeFrame: 84 days
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Hospital- Tel Hashomer
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References:
Clinical trial NCT03213925: Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
Official title: Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Radiation Therapy
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 1
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery or mastectomy followed by radiation therapy. Some patients achieve a complete response after neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for subclinical microscopic disease, the question arises whether breast surgery before radiation therapy can be avoided in the subgroup of patients with complete response after neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Age 40 years or older
* Pathologically confirmed unicentric invasive breast cancer
* Clinical stage T1-3 / N0 or N2 / M0
* Clinical conditions to receive neoadjuvant chemotherapy

Exclusion Criteria:

* Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin)
* Patient is known to be pregnant
* Prior history of radiation therapy in the thoracic region
* Impossibility to perform magnetic resonance imaging

Primary outcomes:
measure: Ipsilateral breast tumor recurrence (IBTR)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Radiology and Oncology of University of São Paulo - Radiation Oncology Unit, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo
Study officials:
References:
Clinical trial NCT02534025: Remote Ischemic Preconditioning in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplanatation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients.

Detailed description: Upper arm ischemia will be induced by elevation of NIBP cuff pressure to 200 mm Hg for 5 minutes repeated four times 5 mniutes apart, aiming to decrease the effect of ischemia reperfusion in the graft liver.

Eligibility criteria: Inclusion Criteria:

* All candidates for living donor liver transplantation

Exclusion Criteria:

* Donors with peripheral vascular disease

Primary outcomes:
measure: liver enzymes ( SGOT and SGPT) as indicator of graft injury
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT00496925: Examining the Usage of Dopamine Blockers in OCD Patients
Official title: Examining the Usage of Dopamine Blockers in OCD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-07-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient and Inpatients

Brief summary: We examine the usage of Dopamine blockers in OCD patients. We want to examine their frequency of usage, compare the course of the disease between those who receive and those who do not receive Dopamine blockers, and efficacy of the treatment.

The study will be done in two stages: 1. Collecting information the usage of Dopamine blockers from 150 OCD patients' files. 2. interviewing 60-70 patients to see the difference those who receive and those who do not receive Dopamine blockers in their current severity of disease.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* DSM-IV diagnosis of OCD
* Ability to understand patient information sheet, and consent to participate

Exclusion Criteria:

* Current or past Psychotic or Bipolar disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00741325: Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).
Official title: Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 5X 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma
Autologous Transplantation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the AMD3100-3101 study (NCT00103610) who received at least one dose of study treatment (plerixafor or placebo)

Brief summary: This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).

Detailed description: This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate granulocyte colony stimulating factor (G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL) patients (protocol AMD3100-3101 \[NCT00103610\]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).

Eligibility criteria: Inclusion Criteria:

* All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610)

Exclusion Criteria:

* No Exclusion Criteria

Primary outcomes:
measure: Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.
Clinical trial NCT00961025: A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitis Type 2
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 110
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.


Eligibility criteria: Inclusion Criteria:

* 20-45 years healthy male subjects
* Body weight :50-90kg, BMI between 18.5-25
* Blood glucose level of 70-110mg/dL on the FPG test

Exclusion Criteria:

* have a family history of diabetes
* Serum AST(SGOT), ALT(SGPT)\>1.25 times upper limit of normal
* Creatinine clearance rate\<80mL/min
* show SBP =\<100mmHg or \>=150mmHg, or DBP=\<65mmHg or \>=95mmHg, or tachycardia (PR\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
* can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects

Primary outcomes:
measure: To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects
timeFrame: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229
Secondary outcomes:
measure: To evaluate the safety and tolerance of DA-1229
timeFrame: up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
state: Chongo-Gu, Yon-Gon Dong
Study officials:
References:
citation: Kim TE, Lim KS, Park MK, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study. Clin Ther. 2012 Sep;34(9):1986-98. doi: 10.1016/j.clinthera.2012.08.006. Epub 2012 Sep 1.
Clinical trial NCT03307525: Pain After Breast Surgery
Official title: A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Society for Ambulatory Anesthesia (SAMBA)
First posted: 2017-10-11
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing elective breast cancer surgery

Brief summary: This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.


Eligibility criteria: Inclusion Criteria:

* English speaking undergoing elective breast cancer surgery

Exclusion Criteria:

* Patients with recurrent cancer, metastasis, and previous breast surgery

Primary outcomes:
measure: Acute Pain
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Persistent Pain
timeFrame: More than 6 months after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
Clinical trial NCT01848925: Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
Official title: A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sickle Cell Disease
Keywords: SANGUINATE
Lead sponsor: Prolong Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.


Eligibility criteria: Inclusion Criteria:

* Patients with Homozygous (HbSS) Sickle Cell Anemia;
* Hb levels: \>6g/dL - \<10g/dL;
* Age : \>18 years old;
* Frequency of ER hospitalizations \< 6x/yr for SCD pain events documented "medical history".

Exclusion Criteria:

* Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
* Allergic to Hydroxyurea;
* History of clinical significant disease, as determined by the Investigator;
* History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
* Screening assessments considered to be abnormal by the Investigator;
* Patient has sever pulmonary hypertension (index \>3 meters per sec);
* Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period;
* Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;

Primary outcomes:
measure: To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Fundacion BIOS
city: Cali
country: Colombia
facility: Fundacion Reina Isabel
city: Medellin
country: Colombia
facility: Hospital Pablo TobinUribe
city: Panama City
country: Panama
facility: PAMRI
Study officials:
affiliation: Hospital Pablo Tobin Uribe
name: Kenny M Galvez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Reina Isabel
name: Luis F Uribe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Punta Pacifica
name: Nestor Sosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion BIOS
name: Angel Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06452225: Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transversus Abdominis Plane Block
External Oblique Intercostal Plane Block
Postoperative Analgesia
Pediatrics
Open Nephrectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.

Detailed description: Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Eligibility criteria: Inclusion Criteria:

* Age ≤ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open nephrectomy.

Exclusion Criteria:

* Abnormal blood coagulation.
* Scar, infection, and tumor of puncture site.
* History or family history of high malignant fever.
* Severe cardiovascular problems.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Mean arterial pressure
timeFrame: Every 15 minutes till the end of surgery
Other outcomes:
measure: Heart rate
timeFrame: Every 15 minutes till the end of surgery
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00820625: Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
Official title: Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Tachycardia
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.


Eligibility criteria: Inclusion Criteria:

* long standing persistent atrial fibrillation \> 6 months and \< 5 years

Exclusion Criteria:

* renal failure
* left atrial size \>55 mm

Primary outcomes:
measure: data collection in view of acute and chronic success rate
timeFrame: 12 months
Secondary outcomes:
measure: data collection of complications in both groups and also procedure parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
Study officials:
affiliation: Asklepios Klinik St. Georg, Department of Cardiology
name: Karl-Heinz Kuck, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fink T, Schluter M, Heeger CH, Lemes C, Maurer T, Reissmann B, Riedl J, Rottner L, Santoro F, Schmidt B, Wohlmuth P, Mathew S, Sohns C, Ouyang F, Metzner A, Kuck KH. Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation: The Randomized Alster-Lost-AF Trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation). Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e005114. doi: 10.1161/CIRCEP.117.005114.