louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00778882: Gene Therapy for Chronic Granulomatous Disease in Korea
Official title: An Open-label, Uncontrolled, Single Center, Phase I/II Trial to Assess the Safety and Efficacy of Autologous Hematopoietic Stem Cells Transduced With MT-gp91 Retroviral Vector in gp91 Defective Chronic Granulomatous Disease Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Chronic Granulomatous Disease
Keywords: Chronic Granulomatous Disease
Retroviral Vector
Gene Therapy
Lead sponsor: Helixmith Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 0
Sex: MALE
Standard ages: CHILD
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 evaluate the safety and efficacy of administration of autologous hematopoietic stem cells transduced with MT-gp91 retroviral vector for patients with X-linked chronic granulomatous disease.


Eligibility criteria: Inclusion Criteria:

* gp91 defective male patients with chronic granulomatous disease: confirmed by DHR
* Weigh greater than or equal to 15 kg
* History of severe infections: more than 2 times
* Performance status: ECOG 0-2
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

  * Heart: a shortening fraction \> 28%; QTc interval \< 0.44
  * Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal; AST \< 3 x upper limit of normal
  * Kidney: creatine \< 2 x normal
  * Blood: WBC \> 2,500/uL; platelet \> 100,000/uL; hematocrit \> 26%
* Written informed consent obtained from patient (or guardian if patients age \< 19)

Exclusion Criteria:

* Presence of a HLA-matched sibling for stem cell donation
* Evidence or history of malignant tumor
* Presence of a severe infection
* Presence of an active tuberculosis
* Uncorrectable electrolyte, Ca, P
* Unable to comply with the protocol or to cooperate fully with the Investigator or site personnel

Primary outcomes:
measure: The incidence of adverse events through 1 year
timeFrame: 1 year
Secondary outcomes:
measure: RCR, insertional mutagenesis, immune response against normal gp91 protein
timeFrame: 1 year
measure: Safety and efficacy of fludarabine/busulfan conditioning
timeFrame: 1 year
measure: Functional reconstitution of respiratory burst
timeFrame: 1 year
measure: Presence of vector-positive cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joong Gon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105882: Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI
Official title: Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Cervical Acute Spinal Cord Injury
Keywords: Spinal Cord Injury
SCI
Complete (AIS A) Traumatic Acute Spinal Cord Injury
Lead sponsor: InVivo Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.


Eligibility criteria: Inclusion Criteria:

* 16-70 years of age, inclusive
* AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
* Recent injury
* Non-penetrating SCI

Exclusion Criteria:

* Terminally ill subjects not likely to be able to participate in follow-up
* Incomplete spinal cord injury (AIS B, C, D, and E injuries)
* No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
* Spinal cord injury associated with significant traumatic brain injury or coma that
* Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
* Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds

Primary outcomes:
measure: Incidence of all Adverse Device Effects of any kind/seriousness.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
measure: American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade
timeFrame: 6 months
measure: Improvements in motor and sensory scores
timeFrame: 6 months
measure: Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: InVivo Therapeutics
name: Richard Toselli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00698282: Single and Multiple Ascending Doses of AZD1981 in Japan
Official title: A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 47
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese and Caucasian males

Exclusion Criteria:

* Other clinically relevant disease or disorders

Primary outcomes:
measure: Adverse events
timeFrame: All the time
measure: Plasma drug concentration
timeFrame: Every hour
Secondary outcomes:
measure: Clinical chemistry
timeFrame: day 1 and 9
Other outcomes:
Locations:
city: Berkshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Europe Chiltern International Ltd, Berkshire, UK
name: Elizabeth Hancox
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02328482: Continuation Protocol to Protocol BBCO-001
Official title: A Pivotal, Multicenter, Open-label, Randomized Withdrawal, Non-Treatment Concurrent Control Study to Assess the Safety, Tolerability, and Efficacy of Cabaletta® in OPMD Patients Who Participated in Study BBCO-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscular Dystrophy, Oculopharyngeal (OPMD)
Lead sponsor: Bioblast Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 9
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: This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

Detailed description: This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

Eligible patients will be randomized to one of the following treatment arms:

* Treatment Arm 1: active treatment; continuation of 30 g IV Cabaletta once a week over an additional 52 weeks.
* Treatment Arm 2: no-treatment concurrent control; discontinuation of IV Cabaletta and follow-up over 52 weeks.

IV Cabaletta will be administered once a week to patients in Treatment Arm 1. All patients, regardless of treatment arm allocation, will undergo the same safety and efficacy assessments during the monthly site visits.

Eligibility criteria: Inclusion Criteria:

1. Adult men and women who participated and completed study BBCO-001
2. Clinical and genetic diagnosis of OPMD
3. Able to provide written informed consent to participate in this study
4. Able to understand the requirements of the study and willing to comply with the requirements of the study

Exclusion Criteria:

1. Pregnant or lactating
2. Currently receiving anticoagulant treatment (e.g., warfarin)
3. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
4. Known hypersensitivity to any ingredient in the Cabaletta IV infusion
5. Currently participating in another clinical trial (other than BBCO-001) or have completed an interventional trial less than 30 days prior to the planned treatment start date

Primary outcomes:
measure: Change in disease markers
timeFrame: 52 weeks
measure: Change in swallowing quality of life
timeFrame: 52 weeks
Secondary outcomes:
measure: Long-term safety and tolerability of repeated intravenous (IV) of Cabaletta 30 g
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Neurological Institute, McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Bernard Brais
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482182: Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy
Official title: Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Diffusion-weighted MRI
18F-FDG PET
Treatment response
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2011-11-30
Enrollment: 35
Sex: ALL
Minimum age (years): 20
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 advanced NSCLC

Brief summary: In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).

Detailed description: Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values:

1. Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR
2. Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve
3. Diffusion parameters on DWI A. Mean ADC B. fDM

Eligibility criteria: Inclusion Criteria:

* Histologically proven NSCLC
* Newly diagnosed Stage stage IV
* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
* At least one measurable primary or other intrathoracic lesion \>= 2cm, according to RECIST
* Performance status of 0 to 2 on the ECOG scale
* Age 18 years or older
* Able to tolerable PET/CT and MRI imaging required by protocol
* Able to give study-specific informed consent

Exclusion Criteria:

* Pure bronchioloalveolar cell carcinoma histology
* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
* Poorly controlled diabetes
* Prior malignancy

Primary outcomes:
measure: DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis
timeFrame: one year
Secondary outcomes:
measure: Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
timeFrame: one year
measure: Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ho Yun Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03499431: Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms
Official title: Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm
Aortic Aneurysm
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Skane University Hospital
First posted: 2018-04-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing complex EVAR at study sites.

Brief summary: The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry

Detailed description: This is a Global, multicenter, prospective, observational, non-randomized, single-arm, open clinical study will evaluate the long term (i.e. \>5 years) safety and efficacy of complex endovascular repair

This study will enroll all patients treated with Fenestrated and Branched devices in Europe and Canada that follow all inclusion criteria and none of the exclusion criteria. The total duration of the study will be of approximately 7 years.

Eligibility criteria: Inclusion Criteria:

* Patient eligibility for enrolment shall be based on known information at the time of the procedure. Information obtained at a later date may contradict these criteria, but this will not be considered a deviation of the Study Plan.

Inclusion criteria

A patient is deemed suitable for inclusion in the study if the patient meets both of the following criteria:

1. Patient requires endovascular repair of a thoracic, thoraco-abdominal or abdominal aortic or aorto-iliac aneurysm having morphology suitable for endovascular repair with complex endograft.
2. Patients (or their legal representative for minor patients) who do not object to (oral non-objection declaration, and signed consent form) collection and transmission of his/her data.

Exclusion Criteria:

* Patients are excluded from enrolment into the study if any of the following are true:

  1. Patients whose imaging follow-up is impossible, i.e. patients who are not able to send their follow up CT scans or Duplex US

Primary outcomes:
measure: Longterm Aneurysm Related Mortality
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04297631: Intraarticular Antibiotic in TKA
Official title: Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antibotics in Cementless Knees
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.

Detailed description: Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Eligibility criteria: Inclusion Criteria:

1. Age over 18
2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

1. Diminished mental capacity
2. Vancomycin allergy
3. Tobramycin allergy
4. Chronic kidney disease stage III and stage IV

Primary outcomes:
measure: Concentration of Antibiotics in Cementless Knees Post op
timeFrame: 1 hour, 4 hours, and 24 hours
Secondary outcomes:
measure: Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.
timeFrame: 1 hour, 4 hours, and 24 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT02064231: A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.


Eligibility criteria: Inclusion Criteria:

1. Had given written informed consent
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance

Exclusion Criteria:

1. Used irrigation during the investigation (flush stoma with water)
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical director
name: Birte p Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03355131: Systems-oriented School Healthy Weight Promotion Based on NASA Mission X Campaign
Official title: Systems-oriented School Healthy Weight Promotion: A Pilot Controlled Intervention Study in Remote Areas School Based on NASA Mission X Campaign
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 245
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study assessed the effect of the National Aeronautics and Space Administration's (NASA's) Mission X (MX) program on children's knowledge, attitude, and practice of healthy eating and active living (HEAL) and weight status in rural elementary schools in Taiwan.


Eligibility criteria: Inclusion Criteria:

* The thirteen public elementary schools in Tamsui, Sanzhi and Shimen Districts, New Taipei City, Taiwan, were the target population. Schools that were in distance within 30 minutes by car from Mackay Medical College were approached. Eight schools agreed to participate. All 3rd and 4th graders of the participating schools were invited to the evaluation program.

Exclusion Criteria:

-

Primary outcomes:
measure: Body mass index
timeFrame: 8-weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mackay Medical College
name: Hsing-Yu Yang, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin YC, Chen HJ, Wang Y, Min J, Wu HC, Carvajal NA, Yang HY. NASA Mission X Program for Healthy Eating and Active Living among Taiwanese Elementary School Students. J Pediatr Nurs. 2019 Nov-Dec;49:e8-e14. doi: 10.1016/j.pedn.2019.06.016. Epub 2019 Jul 12.
Clinical trial NCT01879631: Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases
Official title: Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Keratotomy in Keratoconus Cases
Keywords: radial keratotomy; keratoconus; optical rehabilitation
Lead sponsor: Nisa Hastanesi
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mild to moderate keratoconus cases

Brief summary: Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.


Eligibility criteria: Inclusion Criteria:

* keratoconus with a central corneal thickness (CCT) over 400µm,
* poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
* contact lens intolerance

Exclusion Criteria:

* apical scarring,
* ocular or systemic problem other than keratoconus

Primary outcomes:
measure: outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings
timeFrame: after surgery - 12 to 52 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ophthalmology Department, Nisa Hospital
Study officials:
affiliation: ophthalmologist
name: ibrahim kocak, m.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Utine CA, Bayraktar S, Kaya V, Kucuksumer Y, Eren H, Perente I, Yilmaz OF. Radial keratotomy for the optical rehabilitation of mild to moderate keratoconus: more than 5 years' experience. Eur J Ophthalmol. 2006 May-Jun;16(3):376-84.