louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01617759: Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis
Official title: Diagnostic Study on the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aspergillosis
Infection in an Immunocompromised Host
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Immunocompromised individuals

Brief summary: Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostics. Therefore the performance of an established Aspergillus-specific nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Detailed description: Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients with hematological malignancies. Confirming the diagnosis is rarely accomplished as invasive procedures are impaired by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostic tools. Therefore the performance of an established Aspergillus-specific nested PCR assay in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis

Exclusion Criteria:

* proven CNS infections caused by pathogens other than Aspergillus

Primary outcomes:
measure: Test sensititivity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Mannheim University Hospital
Study officials:
affiliation: Mannheim University Hospital, University of Heidelberg, Germany
name: Dieter Buchheidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264159: Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Heart Failure
Keywords: Developing acute heart failure
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-12-21
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization

Exclusion Criteria:

* Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

Primary outcomes:
measure: Prevention of acute heart failure development in acute MI patients
timeFrame: Three years
Secondary outcomes:
measure: Improvement of clinical outcome in patients with lung impedence-guided treatments
timeFrame: Three years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01416259: A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
Official title: A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: QTc Prolongation
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Male and Female Subjects

Brief summary: This Phase I study will be performed in a double-blind, randomized, crossover design in healthy male and female subjects. The central ECG laboratory will be blinded to treatment. Every effort will be made to enroll equal numbers of males and females into the study.

Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a treatment phase and a final visit, which will be conducted on discharge from the study. Study duration will be 32 days with a total of approximately 12 days of confinement. During the resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at selected time points to assess potential ECG effects. Blood samples for PK evaluation will be collected in conjunction with the ECG time points.


Eligibility criteria: Inclusion Criteria:

* Subjects in good health
* aged between 18-50 years
* weigh at least 50 kg (110 pounds)
* have a body mass index of 18-32 kg/m2 inclusive
* capable of understanding and complying with the protocol
* have signed the informed consent

Exclusion Criteria:

* have a history of drug abuse or are current smokers
* have a known hypersensitivity to Moxifloxacin or granisetron
* a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 ms in men, \> 470 ms in women on the screening ECG
* PR \> 240 ms, QRS \> 110 ms or a history of prolongation of QT interval
* a family history of Long QT Syndrome or cardiac disease
* may not have used any medications or consumed any foods contraindicated in the protocol

Primary outcomes:
measure: QTc Prolongation
timeFrame: From baseline over 48 hours.
Secondary outcomes:
measure: Plasma concentrations of granisetron
timeFrame: From baseline over 48 hours
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
affiliation: Spaulding Clinical Research LLC
name: Albert Dietz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01378559: Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
Official title: Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Intraoperative Complications
Postoperative Complications
Keywords: Penis prosthesis
Titan
Satisfaction
Complications
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital / Frederikssund Hospital.

Brief summary: The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis. This will regard the first prostheses inserted at Herlev Hospital/Frederikssund Hospital.

Patient satisfaction will be assessed by mailing out the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" and recording the patient answers. The most important question will be "Overall how satisfied are you with penile prosthesis?".

Complications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.


Eligibility criteria: Inclusion Criteria:

* Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.

Exclusion Criteria:

* Inability to read Danish

Primary outcomes:
measure: Patient satisfaction assessed by EDITS question 1
timeFrame: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months
Secondary outcomes:
measure: Complications
timeFrame: At the beginning of study when the chart review is conducted
measure: Patient satisfaction assessed by EDITS questions 2-13
timeFrame: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of urology, Herlev Hospital
Study officials:
affiliation: Herlev Hospital, University of Copenhagen
name: Jens Sønksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209559: A Comparative Study of the Air-Q ILA and the ILMA for Ventilation and Intubation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Airway Management
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy ASA class I and II patients scheduled for elective surgery under general anesthesia requiring the use of the LMA.

Brief summary: The objective of this study is to determine if the glottic view obtained with the air-Q Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA) is better than that obtained with the traditionally used intubating laryngeal mask airway (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare effectiveness of ventilation.


Eligibility criteria: Inclusion Criteria:

* healthy ASA class I and II patients scheduled for elective surgery under general anesthesia requiring the use of the LMA

Exclusion Criteria:

* history of acid reflux,
* a BMI ≥ 40kg.m-2,
* require endotracheal intubation,
* have predictors of difficult intubation,
* not candidates for insertion of an ILMA or LMA, including a mouth opening of less than 2.5 cm,
* cannot consent to the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT02600559: Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Official title: An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Keywords: Otitis media
Ear infection
Tympanostomy tubes
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 501
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a history of otitis media requiring bilateral tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
* Subject has a history of sensorineural hearing loss

Primary outcomes:
measure: Number of Subjects With Post-surgical Otorrhea
timeFrame: Week 4
measure: Number of Subjects With Post-surgical Otorrhea
timeFrame: 8 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to Eight Weeks
measure: Caregiver Burden - Ear Discharge Control
timeFrame: Week 4
measure: Caregiver Burden - Ear Discharge Control
timeFrame: Week 8
measure: Caregiver Burden - Ear Drops Administration
timeFrame: Week 8
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Email Otonomy Central Contact for Trial Locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Dean Hakanson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00229359: Characteristics of Post-Traumatic Stress Disorder (PTSD) and Non-PTSD Subjects
Official title: Risk Factors for PTSD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Compare PTSD and non-PTSD subjects on several demographic, cognitive and military variables


Eligibility criteria: Inclusion Criteria:

* Subjects applied for treatment in the MOH rehabilitation centers or the IDF unit for combat reactions and were diagnosed with PTSD

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zohar J, Fostick L, Cohen A, Bleich A, Dolfin D, Weissman Z, Doron M, Kaplan Z, Klein E, Shalev AY; Israeli Consortium on PTSD. Risk factors for the development of posttraumatic stress disorder following combat trauma: a semiprospective study. J Clin Psychiatry. 2009 Dec;70(12):1629-35. doi: 10.4088/JCP.08m04378blu. Epub 2009 Oct 20.
Clinical trial NCT05248659: Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Official title: A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Immunoglobulin A Nephropathy
Keywords: Sibeprenlimab
VIS649
IgAN
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 600
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: This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

Detailed description: This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
* eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

* Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
* Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.

Primary outcomes:
measure: Adverse Events
timeFrame: From baseline to the end-of-trial visit in Week 112.
Secondary outcomes:
measure: Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Over 12 and 24 months
measure: Urine protein/creatinine ratio (uPCR) in a 24-hour collection
timeFrame: At 12 and 24 months
measure: Proportion of Subjects with Clinical Remission as defined in the protocol
timeFrame: At 12 and 24 months
measure: Time to Progression of Chronic Kidney Disease, as defined in the protocol
timeFrame: Over 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: New York
Study officials:
References:
Clinical trial NCT00858559: Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Official title: Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Pacing
Electric Countershock
Ventricular Tachyarrhythmia
Keywords: Implantable cardioverter defibrillator
Remote monitoring
Follow-up
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician.

In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.


Eligibility criteria: Inclusion Criteria:

* Indication for a single-chamber implantable cardioverter-defibrillator (ICD)

Exclusion Criteria:

* Contraindication for ICD
* Indication for dual-chamber ICD or cardiac resynchronization therapy

Primary outcomes:
measure: Significant adverse events, especially death, hospitalization, inadequate device therapies
timeFrame: 27 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 27 months
measure: Number of device follow-ups
timeFrame: 27 months
measure: Quality of life
timeFrame: 27 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Cardiology in Tangram House
Study officials:
affiliation: Cardiology in Tangram House, Düsseldorf, Germany
name: Stefan Perings, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131959: Ticagrelor CytoSorb Hemoadsorption
Official title: Ticagrelor CytoSorb Hemoadsorption (TISORB): Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent or Urgent Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emergent Cardiothoracic Surgery
Bleeding
Drug Removal
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open, multi-center, single arm study
Primary purpose: TREATMENT

Brief summary: TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.


Eligibility criteria: Inclusion Criteria:

Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.

Exclusion Criteria:

Any cardiothoracic surgery \> 48 hours after last dose of ticagrelor.

Primary outcomes:
measure: Primary Pharmacodynamic Endpoint
timeFrame: Immediately before and after cardiopulmonary bypass
measure: Primary Pharmacokinetic Endpoint
timeFrame: Immediately before and after cardiopulmonary bypass
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: England
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: England
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Scotland
Study officials:
affiliation: NIHR Trauma Management, MedTech Cooperative
name: Tom Clutton-Brock, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References: