louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00271388: Vestibular Stimulation to Treat Hemispatial Neglect
Official title: Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemispatial Neglect
Stroke
Keywords: Galvanic Vestibular Stimulation
Hemispatial Neglect
Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-12-30
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones.

Detailed description: The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. With the intention of boosting activity in the damaged left hemisphere, positive and negative current is delivered to the left and right mastoids respectively. While successfully used to rehabilitate gait and balance disorders, the procedure has only once been applied to neglect.

In the present investigation, we will first confirm and then optimize the conditions under which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of the treatment on a much larger clinical scale, and merit the construction of a miniaturized portable device.

Eligibility criteria: Inclusion Criteria:

* All participants must be literate in English
* Right handed
* Have corrected near-visual acuity of 20/40 or better
* Patients must also have a minimum of twelve years education
* These inclusionary criteria are based on the data of both Black, Yu, Martin, and Szalai (90) and our own studies.

  * They are intended to assure that only patients with sufficiently severe symptoms will be admitted to our study.

Exclusion Criteria:

Exclusionary criteria include:

* Homonymous hemianopia
* Presence of a severe field cut extending toward the midline on formal perimetry (however many patients who have field cuts restricted to the periphery will be able to fully perceive our stimulus displays so can be included
* Evidence of aphasia on clinical examination (crossed aphasia)
* A significant history of other neurological or psychiatric illness or drug/alcohol abuse

Primary outcomes:
measure: Measures of Hemispatial Neglect
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
Study officials:
affiliation: VA Medical Center, Jamaica Plain Campus
name: William Milberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386188: Role of the Posterior Parietal Cortex in the Processing of Sensory Information
Official title: Role of the Posterior Parietal Cortex in the Processing of Sensory Information Modulating the Excitability of the Primary Motor Cortex in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subject
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Although the primary motor cortex is considered has the common final pathway of motor commands, it is influenced by several structures as, for example, the premotor cortex and the posterior parietal cortex which are involved in motor planning and programming and which integrates movement-induced sensory impute (parieto-frontal circuits). Several studies have shown that there are some direct functional connections between the premotor cortex and the posterior parietal cortex and from these two regions to the primary motor cortex. The posterior parietal cortex can then be considered as a sensorimotor interface whose function in planification and motor control of upper limb is well demonstrated. The hypothesis is that the posterior parietal cortex could participate to the modulation of motor cortex excitability by proprioceptive sensory inputs namely long latency afferent inhibition and afferent induced facilitation.


Eligibility criteria: Inclusion Criteria:

* Right handed
* No neurological troubles
* Informed consent signed
* Affiliated to a social security

Exclusion Criteria:

* Psychiatric antecedent
* Neurological disease
* Contra-indication to TMS
* Under psychiatric treatment
* Pregnancy
* Contra-indication to MRI

Primary outcomes:
measure: Afferent induced facilitation
timeFrame: Baseline
Secondary outcomes:
measure: Interaction between long latency afferent inhibition and long latency intracortical inhibition (LICI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe Derambure, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02546388: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Official title: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2015-09-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.

OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 or older
* Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
* Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
* PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.

Exclusion Criteria:

* Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
* Patients with history of neuroendocrine tumors (specially insulinomas)
* Patients taking the medication Octreotide
* Patients on total parenteral nutrition (TPN)
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Number of Participants Characterized by Abnormal or Negative Uptake
timeFrame: 1 hour
Secondary outcomes:
measure: Effect of Treatment
timeFrame: 1 hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00601588: Bioequivalency Study of Sertraline Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* Treatment with any triptan within 30 days prior to or during the study.
* History of allergic or adverse response to sertraline or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Fly
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
affiliation: Anapharm
name: Benoit Girard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04822688: Analysis of Cell Count, Viability, and Immunogenicity of Discarded Newly Diagnosed Glioblastoma Tissue or Solid Tumor Tissues
Official title: Analysis of Cell Count, Viability, and Immunogenicity of Deidentified Discarded Newly Diagnosed Glioblastoma Tissue and More Broadly Other Newly Diagnosed Solid Tumor Tissues From the Operating Room
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Malignant Solid Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GBM or other solid tumor and undergoing surgery

Brief summary: This study examines tumor tissues and blood samples to aid in the development of therapies for brain cancer and other solid tumors. Studying samples of blood and tissue from patients with glioblastoma or other solid tumor in the laboratory may help doctors understand brain tumors and better inform future treatments.

Detailed description: PRIMARY OBJECTIVES:

I. Assessment of cell yield and percentage of viable cells upon tissue receipt at the cell processing facility.

II. Obtain discarded tumor tissue from surgical resections for further studies to aid in development of future therapies for glioblastoma (GBM) and other solid tumors.

SECONDARY OBJECTIVE:

I. Assessment of cell yield and percentage of viable cells from other solid tumor cells shipped to the cell processing facility.

EXPLORATORY OBJECTIVE:

I. An additional line of inquiry will be devoted to scientific exploration of the product's immunogenicity looking at important variables in the course of manufacture.

OUTLINE:

Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.

Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent form
* Any individual \>= 18 years old
* Patients must have GBM or other solid tumor and undergoing surgery for diagnostic and therapeutic purposes

Exclusion Criteria:

* Individuals less than 18 years old
* Unable to understand and give consent
* Patients who are not surgical candidates

Primary outcomes:
measure: Cell yield
timeFrame: At study completion, up to 12 months
measure: Percentage cell viability
timeFrame: At study completion, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00632788: The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time
Official title: The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time in Patients Suffering From Acute ST-Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: myocardial infarction
catheterization
angioplasty
door-to-balloon time
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-11
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with diagnostic criteria of acute ST-elevation myocardial infarction who were preparing for emergency cardiac catheterization

Brief summary: This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital


Eligibility criteria: Inclusion Criteria:

* all patients who presented to the emergency department of Far Eastern Memorial Hospital within 12 hours of the onset of ischemic chest pain
* patients with diagnostic criteria of acute ST-elevation myocardial infarction on electrocardiogram, e.g. at least 0.1 mV in two or more contiguous electrocardiographic leads or a new onset of bundle branch block
* patients were preparing for emergency cardiac catheterization

Exclusion Criteria:

* patients who did not fulfill the diagnostic criteria of acute myocardial infarction on electrocardiogram
* patients who were not eligible for cardiac catheterization
* patients who refused cardiac catheterization
* patients who suffered from acute myocardial infarction after admission to ward or intensive care unit for any reason
* patients who had an ambiguous diagnosis that the decision of emergency cardiac catheterization was made after admission to ward or intensive care unit

Primary outcomes:
measure: median door-to-balloon time
timeFrame: at cath. lab
Secondary outcomes:
measure: in-hospital mortality
timeFrame: at hospital discharge
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chao-Lun Lai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai CL, Fan CM, Liao PC, Tsai KC, Yang CY, Chu SH, Chien KL. Impact of an audit program and other factors on door-to-balloon times in acute ST-elevation myocardial infarction patients destined for primary coronary intervention. Acad Emerg Med. 2009 Apr;16(4):333-42. doi: 10.1111/j.1553-2712.2009.00372.x.
Clinical trial NCT02987088: Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Official title: Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival.

Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected


Eligibility criteria: Inclusion Criteria:

1. Intravenous access/intraosseous access
2. Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
3. Age 18 years or older
4. Comatose

Exclusion Criteria:

1. Traumatic cause of cardiac arrest
2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
3. Known DNAR
4. Drowning as cause of arrest.

Primary outcomes:
measure: plasma level of sodium nitrite at hospital arrival
timeFrame: 15-45 minutes after dose has been given
Secondary outcomes:
measure: Rate of re-arrest
timeFrame: 15-120 minutes after dose has been given
measure: Need for pressor support before hospital arrival
timeFrame: 15-120 minutes after dose has been given
Other outcomes:
measure: blood pressure at hospital arrival
timeFrame: at hospital arrival usually 15-60 minutes after cardiac arrest
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Francis Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim F, Dezfulian C, Empey PE, Morrell M, Olsufka M, Scruggs S, Kudenchuk P, May S, Maynard C, Sayre MR, Nichol G. Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest. Am J Cardiol. 2018 Aug 15;122(4):554-559. doi: 10.1016/j.amjcard.2018.04.060. Epub 2018 Jun 20.
Clinical trial NCT00656188: Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-10
Enrollment: 463
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy

Primary outcomes:
measure: Erectile Function domain of the International Index of Erectile Function
timeFrame: 12 weeks
measure: Sexual Encounter Profile Question 2
timeFrame: 12 weeks
measure: Sexual Encounter Profile Question 3
timeFrame: 12 weeks
Secondary outcomes:
measure: Erectile Function domain scores > 26
timeFrame: 12 weeks
measure: Sexual Encounter Profile 2
timeFrame: 12 weeks
measure: Global Assessment Question
timeFrame: 12 weeks
measure: Reliability of insertion
timeFrame: 12 weeks
measure: Reliability of maintenance
timeFrame: 12 weeks
measure: Other subject diary based variables
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05541588: Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy
Official title: Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy; A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.


Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
* scheduled for abdominal hysterectomy surgery.

Exclusion Criteria:

* History of allergy to the medications used in the study.
* Contraindication to regional anesthesia as coagulopathy, local infection.
* Severe hepatic impairment (child C).
* Sever Renal dysfunction (creatinine clearance \< 30).
* Psychiatric or mental disorder affecting patient ability to interpret VAS score.
* Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
* ASA IV.
* Patient refusal.

Primary outcomes:
measure: Post-operative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulative post-operative opioid consumption
timeFrame: 24 hours
measure: The onset of 1st analgesic request
timeFrame: 24 hours
Other outcomes:
measure: Incidence of complications
timeFrame: 24 hours
Locations:
city: Cairo
country: Egypt
facility: Ain Shams univerisity
Study officials:
References: