louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03042416: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Official title: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congenital Hyperinsulinism
Neuroblastoma
Neuroendocrine Tumors
Parkinson Disease
Brain Glioma
Keywords: 18F-DOPA PET/CT
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2017-02-03
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:

1. Pediatric patients with congenital hyperinsulinism
2. Pediatric patients with neuroblastoma
3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor
4. Adult patients with a clinical suspicion of Parkinson's disease
5. Pediatric or Adult patients with primary brain tumors

This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.


Eligibility criteria: Inclusion Criteria:

* 1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism
* 2. Pediatric patients (less than 17 years old) with neuroblastoma
* 3. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas
* 4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.
* 5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors

Exclusion Criteria:

* Unable to obtain consent
* Weight \> 250 kg (weight limitation of PET/CT scanner)
* Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan
* Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist)
* Pregnancy
* Lack of intravenous access

Primary outcomes:
measure: Immediate safety evaluation
timeFrame: Within 1 hour of injection
Secondary outcomes:
measure: Delayed safety evaluation
timeFrame: 10-14 days after injection
measure: Delayed safety evaluation - referring physician
timeFrame: 6 months after injection
measure: Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
timeFrame: Within 3 days after injection
measure: Perceived clinical benefit
timeFrame: 6 months after injection
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jonathan T Abele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03740516: Expanded Access for CC-10004
Official title: Expanded Access for CC-10004
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Bechet's Disease
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-11-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to CC-10004.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01864616: The Impact of Vitamin D on Disease Activity in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn Disease
Keywords: Vitamin D
Crohn disease
Disease activity
Inflammation
prevention
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Dania Alrefai
name: Dr.Jennifer Jones
name: Dr.Hani Jawa
name: Dr.Wael El-matary
name: Saudi Arabian Cultural Bureau
First posted: 2013-05-29
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia

Detailed description: Hypothesis 1: Patients who are suffering from Crohn's disease are at risk of vitamin D deficiency.

To determine vitamin D status and disease activity in Crohn's disease cases in Canada and Saudi Arabia.

Hypothesis 2: Providing vitamin D in doses higher than RDA (Recommended Dietary Allowance) reduces disease activity in Crohn's disease cases.

To evaluate the impact vitamin D in doses higher than RDA (Recommended Dietary Allowance) on disease activity in Crohn's disease patients.

Eligibility criteria: Inclusion Criteria:

* newly diagnosis with an active Crohn's disease,
* age above of 16 years

Exclusion Criteria:

* remission or the duration of disease is more than 2 years,
* pregnancy,
* liver or kidney failure,
* inability to take oral supplements or medicine

Primary outcomes:
measure: The changes in disease activity on groups
timeFrame: (0), 5 weeks, 9 weeks, after 2 months
Secondary outcomes:
measure: nutritional status
timeFrame: 0, 5 weeks, 9 weeks, 2 months later
measure: vitamin D status
timeFrame: (0), Week 5, Week 9 (termination) and 2 months later
measure: Health related quality of life
timeFrame: (0), Week 5, Week 9 (termination) and 2 months later (follow up)
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: IBD clinic; Royal University Hospital
state: Saskatchewan
city: Jeddah
country: Saudi Arabia
facility: Internal Medicine Department; King Abdulaziz University Hospital
Study officials:
affiliation: University of Saskatchewan, Saskatoon, SK,Canada
name: Hassanali Vatanparast, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal University Hospital, Saskatoon, Saskatchewan, Canada
name: Jennifer Jones, MD,MSc,FRCPC
role: STUDY_DIRECTOR
affiliation: King Abdulaziz University, jeddah, Saudi Arabia
name: Hani Jawa, MBBS,ABIM,FRCPC
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Wael El-matary, MBChB,MSc,MD,FRCPCH
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Dania Alrefai, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241916: A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
Official title: A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stiff Elbows
Keywords: elbow, splint
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 66
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: Primary Question: "When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches?"

Secondary Question: "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"


Eligibility criteria: Inclusion Criteria:

* All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity.

Exclusion Criteria:

* Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages.

  * Vulnerable populations will not be recruited.

Primary outcomes:
measure: Change in Arc of Flexion and Extension
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00220116: Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
Official title: A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the 1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the neo-adjuvant and adjuvant setting of resectable metastases.

Primary Endpoint: Objective response rates

Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected) Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause mortality Number undergoing liver resections/curative resection (Ro) rate


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups
* No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
* Unidimensional measurable disease as assessed by CT. (Unless adjuvant therapy only)
* Adequate bone marrow function; Hb \>10g/dl, platelets \>100 x109/l, WBC \>3x109/l, Neut \>1.5x109/l.
* Adequate liver function: Serum Bilirubin \<1.5 x upper limit of institutional normal
* Adequate renal function, calculated Creatinine Clearance \>50mls/min
* No concurrent uncontrolled medical conditions
* WHO performance status 0,1 or 2
* Adequate contraceptive precautions, if appropriate
* Informed written consent
* Negative pregnancy test in women of child bearing age
* Life expectancy \> 3 months

Exclusion Criteria:

* Medical or psychiatric condition that comprise the patient's ability to take informed consent.
* Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months.
* Patients with any significant symptoms or history of peripheral neuropathy.

Primary outcomes:
measure: Objective response rates
Secondary outcomes:
measure: Treatment related toxicity
measure: Progression free survival (If not resected)
measure: Disease free Survival (From metastastectomy, if resected)
measure: Overall Survival
measure: 60 Day all cause mortality
measure: Number undergoing liver resections/curative resection (Ro) rate
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04892316: Using Machine Learning to Adapt Visual Aids for Patients With Low Vision
Official title: Using Machine Learning to Adapt Visual Aids for Patients With Low Vision
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmology
Artificial Intelligence
Low Vision Aids
Keywords: Artificial Intelligence
Low Vision
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visually disabled patients were referred by the Town Disability Federation in Fujian Province and Guangdong Province

Brief summary: According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.

Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility criteria: Inclusion Criteria:

* Low vision
* Aged 3 to 105

Exclusion Criteria:

* Severe systemic disease
* Failure to sign informed consent or unwilling to participate

Primary outcomes:
measure: Accuracy of fitting results for assisting devices
timeFrame: baseline
Secondary outcomes:
measure: Time cost for fitting assisting devices
timeFrame: baseline
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: 2nd Affilliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT05953116: Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study
Official title: Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (ManoPo) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Body Composition
Protein
Exercise
Functional Status
Lead sponsor: Food and Nutrition Research Institute, Philippines
Sponsor class: OTHER_GOV
Collaborators: name: Wageningen University and Research
First posted: 2023-07-19
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.

Detailed description: The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.

Eligibility criteria: Inclusion Criteria:

* Pre-sarcopenia/pre-frail
* Aged 60 years old and above, male or female
* Free-living in the community, ambulatory
* Able to respond to food recall/interview as self-declared
* Normal cardiac function as measured by resting ECG

Exclusion Criteria:

* Bed ridden, unable to perform exercise independently
* Presence of serious medical condition (i.e. cancer, existing fracture)
* Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician
* Renal Problem
* Under controlled or medically-supervised diet not flexible to include the intervention agent
* Allergic to any ingredients in the nutrition supplementation

Primary outcomes:
measure: Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA)
timeFrame: Baseline, Midline (6 weeks), Endline (12 weeks)
measure: Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
timeFrame: Baseline, Midline (6 weeks), Endline (12 weeks)
measure: Change in physical performance, as measured by timed up-and-go test
timeFrame: Baseline, Midline (6 weeks), Endline (12 weeks)
measure: Change in physical performance, as measured by short physical performance battery
timeFrame: Baseline, Midline (6 weeks), Endline (12 weeks)
measure: Change in physical performance, as measured by 10-meter walk test
timeFrame: Baseline, Midline (6 weeks), Endline (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Taguig
country: Philippines
facility: Department of Science and Technology-Food and Nutrition Research Institute
state: Metro Manila
Study officials:
affiliation: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
name: Robby Carlo A Tan, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02639624: Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate
Official title: Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Dialysis
Hemodialysis
Keywords: hemodialysis
kidney
dialysis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.

Detailed description: Investigators will try to perform dialysis with a low bicarbonate bath which will leave patients blood pH (Hydrogen ion concentration) relatively unchanged then switch to a normal bicarbonate bath during the second half of dialysis so that they attain the pH (Hydrogen ion concentration) they normally would. Investigators will use these measurements to test test the hypothesis that Indoxyl Sulfate (IS) binds to proteins with greater affinity under basic conditions and further to test the hypothesis that it is possible to remove a greater amount of Indoxyl Sulfate (IS) when patients are maintained relatively acidotic during dialysis for a longer period of time due to the greater availability of free IS that can pass through the dialyzer.

Eligibility criteria: Inclusion Criteria:

* Chronic Stable Dialysis for at least 6 months

Exclusion Criteria:

* Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L
* Hospitalization within the past 12 months
* Adults unable to consent
* Children
* Pregnant women
* Prisoners

Primary outcomes:
measure: Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls
timeFrame: 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
Secondary outcomes:
measure: Change in pH
timeFrame: 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Jerome Lowenstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02328924: There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?
Official title: There is a Cut Off Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome? A Randomized Controlled Trial in Fixed Versus Flexible Gonadotropin-releasing Hormone Antagonist Protocols.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Lead sponsor: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 213
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study, prospective randomized controlled trial, tried to identify a cut off value of luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible gonadotropin-releasing hormone antagonist protocols.

202 norma-ovulatory women \< 39 years were randomized to fixed or flexible group in GnRH antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and progesterone in the two study groups was measured. Total number of retrieved oocytes, implantation and pregnancy rate were recorded.

.


Eligibility criteria: Inclusion Criteria:

* 1) age \<39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels \< 12 IU/ml; (4) body mass index (BMI) between 18-30 Kg/m2; (5) no oral contraceptive pills taken in the last year

Exclusion Criteria:

* polycystic ovaries, age \>39 years

Primary outcomes:
measure: number of mature oocytes recruited after IVF with antagonist protocol
timeFrame: partecipant will be followed for the duration of the cycle of IVF and for the following three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: