louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00702364: Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Official title: Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain INjury
Keywords: Attention
Traumatic Brain INjury
Atomoxetine
Strattera
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI


Eligibility criteria: Inclusion Criteria:

* History of TBI
* Moderate to severe TBI as indicated by Glasgow Coma Score (GCS) score of 12 or less; or Post Traumatic Amnesia (PTA) of seven days or more
* at least one year post injury
* between the ages of 18-65 (inclusive)
* symptoms consistent with attentional dysfunction
* consent to participate in study

Exclusion Criteria:

* history of any conditions that would prohibit standard neuropsychological testing
* non-English speaking (to the extent that would limit ability to complete study measures)
* prior history of significant psychiatric illness requiring hospitalization
* epilepsy
* cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse
* use of any monoamine oxidase inhibitor or any other drug affecting brain monoamine concentrations
* severe renal or hepatic impairment
* pregnant or lactating

Primary outcomes:
measure: CDR Power of Attention
timeFrame: Post treatment
measure: Stroop Test Interference T-score
timeFrame: Post treatment
measure: Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score
timeFrame: Post treatment
Secondary outcomes:
measure: Neurobehavioral Functioning Inventory Depression Subscale
timeFrame: Post treatment
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: David L Ripley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Craig Hospital
name: Cindy Harrison-Felix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326364: Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection
Official title: Prognostic Value of Baseline CT Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 6
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: pancreatic adenocarcinoma

Brief summary: The purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (VEGF) expression.


Eligibility criteria: Inclusion Criteria:

1. suspected and/or biopsy-proven pancreatic adenocarcinoma, and
2. referral to Radiology for pre-treatment baseline pancreatic protocol CT.

Exclusion criteria:

1) are absolute contraindications to intravenous iodinated contrast or CT scan.

Primary outcomes:
measure: Histological markers of tumor angiogenesis (microvessel density, EGF/VEGF expression level)
timeFrame: 1 day
measure: Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Aya Kamaya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050890: Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
Official title: Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm
Keywords: Breast Cancer
Liquid Biopsy
ctDNA
Pathologic complete response
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 38
Sex: FEMALE
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: Patients diagnosed with breast cancer who are considered possible candidates for neoadjuvant chemotherapy

Brief summary: This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.

Detailed description: Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes.

This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer.

In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.

Eligibility criteria: Inclusion Criteria:

* Information to the patient and signed informed consent;
* Locally advanced breast cancer that is a candidate for neoadjuvant therapy;
* Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2.

Exclusion Criteria:

* Metastatic breast cancer (Stage IV);
* Additional invasive malignant disease;
* Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements;
* Presents any organic condition that makes it impossible to carry out chemotherapy treatment;
* Pregnant or lactating women
* Received previous treatment for breast cancer.

Primary outcomes:
measure: The concentration of circulating DNA(ctDNA)
timeFrame: From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months
Secondary outcomes:
measure: Change from baseline ctDNA alterations to end of neoadjuvant treatment
timeFrame: Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IBCC Oncologia
state: SP
Study officials:
affiliation: IBCC Oncologia
name: Camila Giro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02721290: Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using Two Femoral Block Techniques
Official title: Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using an Ultrasound Plus Neurostimulator Technique Versus an Approach Based on the Localization of the Femoral Artery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Femoral Nerve Block
Keywords: Knee surgery
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.

Exclusion Criteria:

* Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
* Refusal to participate in the study
* Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.

Primary outcomes:
measure: Sensitive cutaneous block distribution area for the two techniques
timeFrame: 45 minutes
Secondary outcomes:
measure: Time of block completion
timeFrame: 45 minutes
measure: Ease of ultrasound visualization of the femoral nerve
timeFrame: 45 minutes
measure: Ease of ultrasound visualization of the femoral artery
timeFrame: 45 minutes
measure: Numbers of needle redirection
timeFrame: 45 minutes
measure: Vascular puncture
timeFrame: 45 minutes
measure: Paresthesia
timeFrame: 45 minutes
measure: Patient Satisfaction
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
Study officials:
References:
Clinical trial NCT03827564: Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease
Official title: Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.


Eligibility criteria: Inclusion Criteria:

* Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
* Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
* The participant should be literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Corneal transplant in either or both eyes
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Women who are pregnant, planning a pregnancy, or nursing throughout the study

Primary outcomes:
measure: Difference in Ratio of Degranulated Goblet Cells.
timeFrame: Screening (Day -60 to Day -30) to Application Visit (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine - Department of Ophthalmology
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Department of Ophthalmology
name: Stephen Pflugfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018090: Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome
Official title: Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome - A Prospective Multicenter Study With Transcranial Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infarction, Brain
Embolism
Atrial Fibrillation
Keywords: Infarction
Embolism
Atrial Fibrillation
Ultrasound
Transcranial Doppler
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
Collaborators: name: University of Giessen
name: University of Padova
name: University of Ostrava
name: Clinical Hospital Centre Zagreb
First posted: 2023-08-30
Enrollment: 61
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: Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours after symptom onset.

Brief summary: This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary aim is to determine the proportion of patients with MES and the association of MES with functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.


Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours after symptom onset.

Exclusion Criteria:

* use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.

Primary outcomes:
measure: Prevalence of MES
timeFrame: Within 24 hours of symptom onset
measure: Poor functional outcome
timeFrame: 90-days after stroke
Secondary outcomes:
measure: Ordinal Shift Analysis of mRS scale score
timeFrame: 90-days after stroke
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Pedro Miguel Castro
Study officials:
References:
Clinical trial NCT02090790: Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block
Official title: The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: dexamethasone
femoral block
total knee arthroplasty
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients

Detailed description: Total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used.

Dexamethasone is a glucocorticoid of high potency and frequently used perioperative.Dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.If the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.

Eligibility criteria: Inclusion Criteria:

* between 18-65 age
* knee arthroplasty
* no known allergies to drugs
* ASA 1-2 patients

Exclusion Criteria:

* history of diabetes
* history of chronic pain treatment
* pregnancy
* severe bronchopulmonary disease
* systemic opioid and steroid use

Primary outcomes:
measure: visual analog scale
timeFrame: postoperative 2 day
Secondary outcomes:
measure: analgesic consumption
timeFrame: postoperative 2 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Univercity Hospital
Study officials:
affiliation: erciyes univercity
name: ahmet öner, recident
role: PRINCIPAL_INVESTIGATOR
affiliation: erciyes univercity
name: gülen güler, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00578890: a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis
Official title: Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetic Foot
Keywords: diabetic foot
osteomyelitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-12-21
Enrollment: 0
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: Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. The medical treatment risk is a longer healing time and a risk of bone infection relapse. The surgical treatment risk is the ulcer relapse because of the modification of the foot structure. These treatments need to be compared in terms of benefit/risk ratio. Our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate.

Detailed description: The study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). The therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite

Eligibility criteria: Inclusion Criteria:

* diabetes
* neuropathy and a forefoot ulcer
* osteomyelitis on X ray involving one or two contiguous ray
* confirmed osteomyelitis on bone biopsy if a metatarsal head is involved
* palpable distal pulses

Exclusion Criteria:

* glomerular filtration rate \< 30ml/min
* whole bone destruction
* contra-indication for off loading
* ASAT or ALAT \> three times normal rate
* immunosuppressive drugs
* Charcot foot on the concerned foot
* pregnancy

Primary outcomes:
measure: no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing
timeFrame: 12 months after healing
Secondary outcomes:
measure: amputation rate
timeFrame: before healing
measure: healing time
timeFrame: end of study
measure: ulcer relapse 12 months after healing
timeFrame: 12 months after healing
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Agnès Hartemann-Heurtier, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385190: Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men
Official title: An Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Study Drug Administred Orally to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: SAD
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Primary outcomes:
measure: Safety and pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: Minato-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: