louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04055688: Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
Official title: Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Glioma
Keywords: Orbeye Surgical Microscope
fluorescence-guided surgery
5-ALA
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Olympus Corporation
First posted: 2019-08-14
Enrollment: 20
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: Glioma patients at Moffitt Cancer Center

Brief summary: 5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.

This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.


Eligibility criteria: Inclusion Criteria:

* Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
* Indication for craniotomy for removal of a suspected or recurrent brain tumor
* Karnofsky Performance Scale \>/- 60%

Exclusion Criteria:

* Prophyria, hypersensitivity to porphyrins
* Renal insufficiency as defined per protocol
* Hepatic insufficiency as defined per protocol
* Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
* Nursing women or women using inadequate contraception

Primary outcomes:
measure: Compare Visualized Fluroescence within brain tumors
timeFrame: Surgery day one
Secondary outcomes:
measure: Volume of Residual tumor
timeFrame: up to 48 hours after surgery
measure: Number of Patients experiencing Adverse Events
timeFrame: Up to 16 days after surgery
Other outcomes:
measure: Post Surgery Questionnaire
timeFrame: Surgery day one
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer and Research Institute
name: Michael A Vogelbaum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527188: Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis Due to House Dust Mite
Keywords: HDM
allergic rhinitis
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* history of HDM rhinitis allergy for \> 1 year
* sensitized to D. pteronyssinus and/or D. farinae
* RTSS \>= 6 at least 2 time points during allergen challenge session

Exclusion Criteria:

* co sensitization to other allergen than HDM
* FEV1 \< 80%
* Asthma GINA \> 1

Primary outcomes:
measure: Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge
timeFrame: 6 months
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research / PRACS Institute
name: Peter Couroux, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004788: Study of Nutritional Factors in Porphyria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2000-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Determine whether differences in dietary habits are associated with disease activity in patients with acute intermittent porphyria.

II. Determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements.

III. Determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks.

IV. Assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods, including zinc and pyridoxine status.

V. Determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients.

VI. Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks.

Detailed description: PROTOCOL OUTLINE: Women record diet intake for at least 1 cycle (28 days), then undergo a comprehensive nutritional assessment at least once during the follicular and luteal phases of the cycle.

Men also record diet intake for at least 1 month and undergo indirect calorimetry and other studies.

All patients receive a comprehensive analysis of diet and energy metabolism. Energy expenditure, resting metabolic rates, and basal metabolic rates are determined with indirect calorimetry, including measurements taken during the follicular and luteal phases of the cycle. Other testing includes hormone assays, serology for nutritional studies, and a urinary metabolite profile. Zinc, lead, and other metals are measured by atomic absorption spectroscopy.

The diagnosis of acute intermittent porphyria is confirmed by erythrocyte porphobilinogen deaminase; urinary aminolevulinic acid, porphobilinogen, and porphyrins; and total fecal porphyrins.

Patients hospitalized for acute attacks of porphyria during the study will receive standard treatment, including intravenous hematin and parenteral support.

Eligibility criteria: * Acute intermittent porphyria
* Variegate porphyria and hereditary coproporphyria eligible but analyzed separately

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT01563588: Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
Official title: Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Metastatic Breast Cancer
Keywords: breast cancer
chemotherapy
first line treatment
treatments include a chemotherapy
last treatment not performed more than 9 months earlier
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 251
Sex: FEMALE
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: Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.


Eligibility criteria: Inclusion Criteria:

* breast cancer
* treatment including a chemotherapy
* in complete remission
* last treatment in the last 9 months before inclusion
* signed consent

Exclusion Criteria:

* metastatic disease
* relapse
* women enable to have physical activity
* heart disease or any pathology preventing physical activity

Primary outcomes:
measure: Quality of life (SF36)
timeFrame: one year after inclusion
Secondary outcomes:
measure: Anxiety/depression scores (HAD)
timeFrame: inclusion, 6, 12, 18, 24, 36 months
measure: Weight and morphometric measures
timeFrame: inclusion, 6, 12, 18, 24, 36 months
measure: Sleep quality
timeFrame: inclusion, 6, 12, 18, 24, 36 months
measure: economic figures
timeFrame: during 2 years after inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
state: Puy de Dome
city: Clermont-Ferrand
country: France
facility: Pole Santé-République
state: Puy de Dome
Study officials:
References:
Clinical trial NCT03104088: Studying Cognition in SPG4
Official title: Studying Cognition in SPG4 Compared to Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Hereditary Spastic Paraplegia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Probands will be recruited at the HSP Outpatient Clinic of the Department of Neurology in Tübingen. Eligible participants are age 18 to 70 years of age. Group 1 include p: patients with genetically confirmed SPG4 (group 1) and manifest disease with spastic gait disorder. Group 2 includes age- and sex-matched and healthy controls (spouses, other relatives or further healthy controls) with an educational level comparable to group 1 (group 2).

Brief summary: Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.

Detailed description: Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using the CANTAB® and MoCA.

Eligibility criteria: Inclusion Criteria:

* Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control
* Age 18 to 70 years
* Written, informed consent

Exclusion Criteria:

* Lack of ability for a written, informed consent
* Presence of gait disorder or other neurological condition (for healthy controls)

Primary outcomes:
measure: Identifying cognitive affected domains by using CANTAB
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: University Hospital Tübingen, Center for Neurology
Study officials:
affiliation: University Hospital Tübingen, Center for Neurology
name: Ludger Schöls, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rattay TW, Boldt A, Volker M, Wiethoff S, Hengel H, Schule R, Schols L. Non-motor symptoms are relevant and possibly treatable in hereditary spastic paraplegia type 4 (SPG4). J Neurol. 2020 Feb;267(2):369-379. doi: 10.1007/s00415-019-09573-w. Epub 2019 Oct 23.
Clinical trial NCT05151978: Transcranial Doppler in Mild and Moderate Traumatic Brain Injury (TBI)
Official title: Transcranial Doppler as an Early Predictor of Neurological Outcome in Mild and Moderate Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma, Brain
Keywords: Trans , cranial, TBI
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 105
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with TBI

Brief summary: Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury

Detailed description: Transcranial Doppler done to TBI patients on admission and follow up was done and Secondary Neurological deterioration was documented

Eligibility criteria: Inclusion Criteria:

* patient with traumatic brain injury and glasgow coma scale 9_15

Exclusion Criteria:

Unstable or patient on Mechanical ventilation, Sever brain injury , patient receive anticoagulant

Primary outcomes:
measure: Secondary Neurological deterioration
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Head of faculty of medicine
name: Ahmed Goneim
role: STUDY_CHAIR
References:
Clinical trial NCT00266578: A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Official title: Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2005-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older.
* Age older than or equal to 3 years and younger than or equal to 30 years
* Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
* Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD\[11\].
* Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated.
* If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease.
* Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD).
* 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology.

Exclusion Criteria:

* Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.

Primary outcomes:
measure: Histologic remission
timeFrame: 5 years
Secondary outcomes:
measure: Furrowing, Epithelial hyperplasia, clinical symptoms
timeFrame: 5 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E. Rothenberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937378: Treatment of Patients With Nocturia (Non-PK Study)
Official title: A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Serenity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 326
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Male and Female 50 years or older
* Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

* CHF
* Diabetes
* Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
* Incontinence
* Illness requiring steroids
* Current or past urologic malignancy
* Nephrotic Syndrome
* Unexplained pelvic masses
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Sleep Apnea
* Pregnant or breast feeding

Primary outcomes:
measure: Change in Mean Number of Nocturic Episodes/Night
timeFrame: 7 weeks
measure: Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: University Urology Associates
state: New York
Study officials:
References:
Clinical trial NCT00646178: Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
Official title: Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Psoriatic
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 102
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: Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy


Eligibility criteria: Inclusion Criteria:

* Moderate to severe PsA
* Inadequate response to DMARD therapy
* Corticosteroid stable dose \<=10 mg QD
* DMARDs must have been taken for 3 months and stable dose for 4 weeks
* MTX maximum dose = \<=30 mg/week
* Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

* No other active skin disease

Primary outcomes:
measure: ACR20
timeFrame: Week 12
measure: Adverse Events
timeFrame: Throughout the Study
Secondary outcomes:
measure: ACR50/70
timeFrame: Week 12
measure: Modified Psoriatic Arthritis Response Criteria
timeFrame: Week 12
measure: Multiple QOL Assessments
timeFrame: Week 12
measure: Physicians Global Assessment for Psoriasis
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01353378: Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium
Official title: Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium
Keywords: dexmedetomidine
emergence delirium
sevoflurane anesthesia
preschool children
oral maxillofacial surgery
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2011-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.

Detailed description: Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.

Eligibility criteria: Inclusion Criteria:

* preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

* mental diseases
* history of neural system disease
* sedative medication history
* anticipated difficult airway

Primary outcomes:
measure: post anesthesia emergence delirium scale(PAED scale)
timeFrame: 2 hours post-surgery
Secondary outcomes:
measure: Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)
timeFrame: 2 hours post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
name: Hong Jiang, MD, PHD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
name: Rong Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: