louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02285387: Rhythm Control of AF in Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 300
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: Prospective randomized (rhythm control or rate control) Objective of study

1. To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)


Eligibility criteria: Inclusion Criteria:

1. Patients with Atrial fibrillation (20\~80 years old)
2. patients with Acute stroke within 7 days
3. LA diameter \< 55mm
4. patients possible to anticoagulation and anti arrhythmic drug
5. NIHSS score ≤12

Exclusion Criteria:

1. Hemorrhagic transformation
2. Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
3. active internal bleeding
4. Impossible to anticoagulation or anti arrhythmic drug
5. Valvular AF (MA\> GII, Mechanical valve, Mitral valve replacement)
6. LV ejection fraction \< 30%
7. Structural cardiac disease
8. Catheter ablation history for AF, Cardiac surgery
9. Already prescribed anti arrhythmic drugs
10. With severe medical disease
11. Expected survival \< 1year
12. Severe alcoholics, drug addiction

14. Contraindication to MRI 15. Pregnancy

Primary outcomes:
measure: acute stroke with AF
timeFrame: 1 year
measure: recurrence of silence stroke
timeFrame: 1 year
measure: recurrence of AF after rhythm control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
citation: Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.
Clinical trial NCT02616887: Study of Image-Guided SBRT for Vertebral Metastases
Official title: Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vertebral Metastases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 26
Sex: ALL
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: Patients with spine metastases

Brief summary: Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.

Detailed description: This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.

The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18years.
* WHO performance status ≤ 2 (ECOG - KPS).
* Histologically-proven of primary cancer disease.
* Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
* Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
* A paraspinal mass ≤ 5 cm.
* Minimal residual tumor after surgery
* Metastases in other district of the body are allowed.
* Informed consent.

Exclusion Criteria:

* \> 50% loss of vertebral body height.
* Prior radiation to the interested spine.
* Patients for whom an MRI of the spine is medically contraindicated.
* Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.

Primary outcomes:
measure: Toxicity of single fraction SBRT on spine metastases using CTCAE v.4
timeFrame: 1 year
measure: Local control of the treated lesions using Kaplan-Meyer statistical curves
timeFrame: 1 year
Secondary outcomes:
measure: Pain control at treated sites after RT using CTCAE v.4
timeFrame: 3 months
measure: Local control of the metastatic disease using Kaplan-Meyer statistical curves
timeFrame: 3 months
measure: Overall survival of treated patients using Kaplan-Meyer statistical curves
timeFrame: 1 year
measure: Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4
timeFrame: 3 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Ciro Franzese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03376087: Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
Official title: Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
heart block
sudden cardiac death
loop recorder
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Pirogov Russian National Research Medical University
First posted: 2017-12-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy

Brief summary: Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.

The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures


Eligibility criteria: Inclusion Criteria:

1. Hard-to-treat focal epilepsy
2. Aged 18 to 60 years
3. If female not pregnant

Exclusion Criteria:

1. Known clinical relevant structural cardiac disease
2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
3. Use of beta blockers or other antiarrhythmic medication
4. Diagnosis of psychogenic non-epileptic seizures

Primary outcomes:
measure: Identification of a dysrhythmia
timeFrame: 3 years or until the end-of-battery life of Reveal XT, whichever came first
Secondary outcomes:
measure: The number of patients who will have receive the permanent pacemaker at the end of the study.
timeFrame: 3 years or until the end-of-battery life of Reveal XT, whichever came first
Other outcomes:
Locations:
Study officials:
References:
citation: Serdyuk S, Davtyan K, Burd S, Teryan R, Kharlap M, Drapkina O. A case of sudden unexpected death of a patient with epilepsy: Continuous electrocardiographic monitoring and autopsy results. HeartRhythm Case Rep. 2018 Nov 30;5(3):138-142. doi: 10.1016/j.hrcr.2018.11.014. eCollection 2019 Mar. No abstract available.
citation: Serdyuk S, Davtyan K, Burd S, Drapkina O, Boytsov S, Gusev E, Topchyan A. Cardiac arrhythmias and sudden unexpected death in epilepsy: Results of long-term monitoring. Heart Rhythm. 2021 Feb;18(2):221-228. doi: 10.1016/j.hrthm.2020.09.002. Epub 2020 Sep 8.
Clinical trial NCT00430287: Does the Optic Disc Grading Done Visually by Your Doctor Agree With Optic Nerve Testing Which is Done by Machines?
Official title: Correlation of DDLS Grading to OCT, HRT, and HVF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: primary open angle glaucoma
low tension glaucoma
pigmentary glaucoma
exfoliative glaucoma
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-02-01
Enrollment: 101
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma service

Brief summary: The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).

Detailed description: The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.

Eligibility criteria: Inclusion Criteria:

* Vision 20/50 or better
* Less than 3 diopters of astigmatism
* 3 diopters or less of myopia or hyperopia
* Pattern Standard Deviation on HVF less than 2.5dB in normals
* Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients

Exclusion Criteria:

* Abnormalities of cornea or ocular media
* Significant ocular pathologies affecting visual field
* History of hypotony
* Ocular surgery within 6 months
* Nystagmus
* Unreliable visual fields
* OCT signal strength scan less than 6

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Glaucoma Service
name: Jonathan S Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02282787: Dexmedetomidine Adjuvant in Retinal Surgery
Official title: DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peribulbar Anesthesia
Keywords: local anesthesia
peribulbar anesthesia
DEXMEDETOMIDINE
vitreoretinal surgery
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration and unexpected globe movement .so many adjuvant was added to LA to overcome this disadvantages of LA such as clonidine and fentanyl .

The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Going for elective vitreoretinal surgery.

Exclusion Criteria:

* History of coagulation abnormalities.
* Allergy to local anesthetics.
* Cardiac, hepatic or renal failure,
* Chronic clonidine or analgesic therapy.
* One-eyed patients

Primary outcomes:
measure: onset, duration of the motor and sensory block
timeFrame: 10 minutes from injection
Secondary outcomes:
measure: observe the adverse effects of Dexmedetomidine
timeFrame: during and after surgery
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz University Hospital at King Saud University
Study officials:
affiliation: King Saud University
name: Marwan Abouammoh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04426487: Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
Official title: Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Traumatic Brain Injury
Keywords: Progesterone
Transcranial doppler
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .

Detailed description: Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

Eligibility criteria: Inclusion Criteria:

* Traumatic subarachinoid hemorrhage

Exclusion Criteria:

* History of malignency

  * History of cerebrovasculer stroke
  * Morbid obese

Primary outcomes:
measure: Number of participants suffering neuronal infarction
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: ElMinia University
state: Abohelal
Study officials:
affiliation: Faculty of medicine. ElMinia University
name: Hany Mikhail, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03625687: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Respiratory Failure
Hepatitis C
Keywords: Lung disease
Lung Transplant
HCV
Hepatitis C
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Detailed description: The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.

Eligibility criteria: Inclusion Criteria:

* Met MGH transplant center criteria, listed for lung transplant
* Able to sign informed consent

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* HIV positivity
* Any contra-indication to lung transplantation per center protocol
* For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
* For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.

Primary outcomes:
measure: Undetectable Blood HCV RNA Level
timeFrame: 12 weeks post last dose of treatment with DAA
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 8 weeks
measure: Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond T Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542787: Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
Official title: A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spasticity in People With Multiple Sclerosis
Keywords: MS
Spasticity
VSN16R
Lead sponsor: Canbex Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Detailed description: Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of MS
* Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.
* Spasticity due to MS of at least 3 months duration with minimum mean score of \>/=2 mASH

Exclusion Criteria:

* Acute MS relapse requiring treatment with steroids within 30 days of screening.
* Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
* Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
* Significant renal and hepatic abnormalities
* Previous history of other significant medical disorders

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 26 days
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: 26 days
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: University College London Hospitals
name: Dr Rachel Farrell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487487: Study of Mental Fatigue in Polio Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-Poliomyelitis Syndrome
Keywords: Candidates for this study are survivors of paralytic poliomyelitis
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2007-06-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Be a survivor of poliomyelitis
* Willing to attend two clinic visits for completion of screening procedures and required tests

Exclusion Criteria:

* Suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Postpolio Syndrome Outpatient Research Office
state: Maryland
Study officials:
References: