louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00539773: Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
Official title: Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transitional Carcinoma of Urinary Bladder
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II Trial of concurrent administration of intravesical BCG \& Interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.


Eligibility criteria: Inclusion Criteria:

* Patients with superficial transitional carcinoma of the urinary bladder

Primary outcomes:
measure: Efficacy
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia
name: Shouki Bazarbashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768573: Taste Test of a New Formulation of Sildenafil (Revatio)
Official title: A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: None Volunteer
Keywords: taste test
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: taste of formulation

Detailed description: taste test None

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* History of hypersensitivity to test compounds or excipients.

Primary outcomes:
measure: palatability (aroma, flavour texture and mouth feel)
timeFrame: Duration of study.
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01001273: Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
Official title: Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Keywords: Pancreas Transplantation
Kidney Transplantation
Organ Transplantation
Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2009-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.


Eligibility criteria: Inclusion Criteria:

* Male or female patient over 18 years of age
* Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
* Able to give written informed consent prior to any study specific procedure

Exclusion Criteria:

* Multi-organ transplant other than kidney transplant
* No central venous access available to deliver the D20W solution

Primary outcomes:
measure: The number of post-transplants all complications up to 30 days (Clavien grading).
timeFrame: 30 days post-operative
Secondary outcomes:
measure: The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)
timeFrame: 30 days post-op
measure: The length of hospital stay (days)
timeFrame: Length of hospital stay (day 1 until discharge)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hospital Royal Victoria
state: Quebec
Study officials:
References:
Clinical trial NCT03376373: Neurotherapy to Promote Emotion Recognition in Autism
Official title: Neurotherapy to Promote Emotion Recognition in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 28
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than previously thought and heterogeneous in expression, though uniformly characterized by severe social disability. The social disability that defines ASD pervades other areas of adaptive behavior, is predictive of secondary mental health problems, and adversely affects long-term outcome. Although ASD is a chronic condition, there has been little research on interventions for adults with ASD. This study proposes to first establish the neural plasticity of specific brain mechanisms underlying difficulties with facial emotion recognition, a core deficit believed to be pivotal in the behavioral expression of ASD-social disability. The investigators will then develop a novel, computer-based intervention using real-time feedback, to the user, to ameliorate emotion recognition deficits.

Detailed description: Individuals with autism spectrum disorder (ASD) are known to have difficulty in the recognition of facial emotion. Such deficits in facial emotion recognition (FER) are thought to cause or exacerbate social disability in ASD by preventing 1) accurate detection of social/emotional information conveyed through the face and, subsequently 2) the deployment of emotionally appropriate responses. Consistent with this model, FER deficits are correlated with social disability in ASD and confer morbidity above and beyond core symptoms.

The long-term goal is to understand how FER networks can be manipulated for therapeutic and preventative purposes. In this trial, investigators are testing the feasibility of an intervention that capitalizes on our previously developed brain-computer interface (BCI) to promote FER in a mixed virtual reality world. The new "FER Assistant" tool (deployed on a tablet - iPad) is intended to aid users in detecting emotions and intents of 'avatars' inhabiting a virtual world, and will provide users with a highly realistic testbed for practicing FER skills in concert with BCI.

Eligibility criteria: Inclusion Criteria:

* diagnosis of ASD

Exclusion Criteria:

* No severe psychopathology which warrants other immediate treatment

Primary outcomes:
measure: facial emotion recognition (RMET)
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Child Study Center
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Richey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417573: Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Official title: Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: IgG Deficiency
Infections
Keywords: Immunodeficiency
Gammaglobulin
IgG subclass deficiency with recurrent infections
Lead sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
Sponsor class: OTHER
Collaborators: name: Grifols Therapeutics LLC
First posted: 2007-01-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
* Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

Detailed description: \*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.

Eligibility criteria: Inclusion Criteria:

* Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.

Exclusion Criteria:

* Patients with panhypogammaglobulinemia or selective IgA deficiency.

Primary outcomes:
measure: Lab values ck'ed baseline and with each treatment, and 15 mo. visit
measure: Xray of Chest and sinus baseline and on 12th and last treatment
measure: Clinical assessment baseline, every treatment, and 15 mo.
Secondary outcomes:
measure: Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Center for Rheumatic Disease, Allergy, Immunology
state: Missouri
Study officials:
affiliation: Center for Rheumatic Disease, Allergy, Immunology
name: Nabih I Abdou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin G subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267-74. doi: 10.1159/000199723. Epub 2009 Feb 12.
Clinical trial NCT00864773: The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy
Official title: Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin, Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. The aim of this study is To investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of central serous chorioretinopathy
* Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography
* Presence of focal leaks at the level of the RPE on fluorescein angiography

Exclusion Criteria:

* Known side effects of systemic bevacizumab administration
* Have a significant cardiovascular or thromboembolic history or were pregnant

Primary outcomes:
measure: Concentrations of growth factors and inflammatory cytokines in Aqueous humor
timeFrame: at baseline
Secondary outcomes:
measure: Central macular thickness at optical coherence tomography
timeFrame: baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04659473: Spanish Survey on Third Wave of COVID-19
Official title: COVID-19, the Third Wave Update People Coping With the COVID-19. A Cross-sectional Online Spanish Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
Epidemiology
Signs and Symptoms
Spain
Rapid online survey
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample was selected from the Spanish community population

Brief summary: Due to the pandemic situation, a rapid online survey may be the best method to assess and track people's pandemic cooping. Regarding the huge media influence and the government's restrictions to control the spread of covid-19; it is needed to know more about people's perception and situation to conduct future contentions plans. This study aims to apply a rapid online survey to determine the Spanish situation in this third wave of the pandemic. The survey will be delivered to 1000 participants to obtain a representative sample. It would be divided into six sections (general information, demography data, social and consuming habits, Covi-19 question, questions for Covid-19 positive, and questions for Covid-19 negative).


Eligibility criteria: Inclusion Criteria:

* Owning online connection
* Ability to answer and complete the survey

Exclusion Criteria:

* None

Primary outcomes:
measure: What's your work or study system nowadays?
timeFrame: 20 seconds
measure: Habits before the Covid-19 pandemic
timeFrame: 60 seconds
measure: Habits in the Covid-19 pandemic
timeFrame: 60 seconds
measure: Personal Covid-19 exposure and disease
timeFrame: 10 seconds
measure: Positive Covid-19: tests, diagnosis, symptoms and quarantine
timeFrame: 60 seconds
measure: Negative Covid-19: tests and quarantine
timeFrame: 40 seconds
measure: Expectations
timeFrame: 10 seconds
Secondary outcomes:
measure: Date of birth
timeFrame: 20 seconds
measure: Sex
timeFrame: 20 seconds
measure: Height
timeFrame: 20 seconds
measure: Weight
timeFrame: 20 seconds
measure: Blood type
timeFrame: 20 seconds
measure: Pathologic history
timeFrame: 20 seconds
measure: Region of residence
timeFrame: 20 seconds
measure: City of residence
timeFrame: 20 seconds
measure: Rural or urban environment
timeFrame: 20 seconds
measure: Cohabitants in the family unit
timeFrame: 20 seconds
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
affiliation: University of Salamanca
name: Beatriz M Bermejo-Gil, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02810873: Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
Official title: PET Imaging of Breast Cancer Using Oncogene Expression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-06-23
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.

Detailed description: OBJECTIVES:

I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.

II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).

III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.

OUTLINE: This is a dose-finding 2-stage study.

STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.

STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.

Eligibility criteria: Inclusion Criteria:

* Female
* Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
* Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
* Signed informed consent form approved by the institutional review board (IRB)

Exclusion Criteria:

* Pregnant or lactating female
* Patient with asthma

Primary outcomes:
measure: Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
timeFrame: 4 hours after Cu 64 TP3805 administered
Secondary outcomes:
measure: Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)
timeFrame: 4 hours after Cu 64 TP3805 administered
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University
name: Madhukar Thakur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247073: Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery
Official title: A Randomized Controlled Trial to Evaluate the Mostafa Maged Four-stitch Technique in Comparison With the Regular Method in Closure of the Episiotomy During Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Delivery
Suture, Complication
Tear; Cervix
Hematoma
Ecchymosis
Keywords: Primigravida,
Episiotomy,
Childbirth,
Mostafa Maged
ecchymosis
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 25 Patients of controlled group with routine closure of the episiotomy 25 Patients of study group with Mostafa Maged technique for closure of the episiotomy
Primary purpose: PREVENTION

Brief summary: Most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth. There are many types of episiotomy which are median, mediolateral, and J-shaped episiotomy.

Prevention of the formation of the dead space during the repair of episiotomy so avoiding hematoma formation in the episiotomy area after child-birth.

The Mostafa Maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm.

Detailed description: Methodology: This technique will be applied to all women with episiotomy at the time of delivery or having tears in the perineum or the vagina. The technique uses absorbable vicryl threads with round needles 75 mm long. The technique includes the vaginal epithelium and the deep muscle layer together continuously at the same sutures. Assessment of the perineal area in the next twenty-four hours till discharge looking for (edema - hematoma - septic wound - continence - ecchymosis - dyspareunia).

Eligibility criteria: Inclusion Criteria:

1. Primigravida patients having episiotomies or tears in the vagina
2. Age between 18 to 40 years old

Exclusion Criteria:

1. Smokers
2. Diabetics
3. Morbidly obese patients
4. Chronic diseases such as renal diseases

Primary outcomes:
measure: Heamostasis of the episiotomy
timeFrame: 4 weeks after delivery
measure: No edema at the site of episiotomy
timeFrame: 4 weeks after delivery
measure: No infection at the episiotomy
timeFrame: 4 weeks after delivery
Secondary outcomes:
measure: Sexual dysfunction (pain during sexual intercourse)
timeFrame: 4 weeks after delivery
measure: Anorectal dysfunction
timeFrame: 4 weeks after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
name: Laila E Abdelfattah, Ass. prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681873: Validation of Low Dose CT for Diagnosis of Lung Nodules
Official title: Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Metastasis to Lung
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 78
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have developed an extremely low dose computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. The investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest CT.


Eligibility criteria: Inclusion Criteria:

* Pediatric and young adult patients (ages 4 to \<21 years)
* Known or suspected malignancy other than lymphoma
* Undergoing clinically indicated CT of the chest

Exclusion Criteria:

* Pregnancy identified by routine Department of Radiology verbal screening
* Prior enrollment in the same study (no patient will be enrolled more than once)
* Inability to provide consent and/or assent
* Lymphoma

Primary outcomes:
measure: Diagnostic performance of extremely low dose CT
timeFrame: At time of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Burnet Campus
state: Ohio
Study officials:
References:
citation: Thapaliya S, Gilligan LA, Brady SL, Anton CG, Crotty EJ, Nasser MP, Geller JI, Pressey JG, Zhang B, Dillman JR, Trout AT. Comparison of 0.3-mSv CT to Standard-Dose CT for Detection of Lung Nodules in Children and Young Adults With Cancer. AJR Am J Roentgenol. 2021 Dec;217(6):1444-1451. doi: 10.2214/AJR.21.26183. Epub 2021 Jul 7.