louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03170531: A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning
Official title: A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: MRI
MR imaging
17-267
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrollment in this study will be open to all MSKCC employees to act as healthy volunteers provided they meet the eligibility criteria for the protocol. Employees who provide consent willfully and voluntarily may participate as a healthy volunteer once. Employees who are under direct supervision of any investigators on the study will not be eligible to participate. An IRB approved flyer with pertinent contact information will be distributed throughout the institution to inform all MSKCC employees of the possibility of participating in this study. No preferences will be given by race or gender for the selection of participants.

Brief summary: The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers age 18 or older

Exclusion Criteria:

* Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
* Volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
* Female volunteers who are pregnant or nursing
* Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
* Volunteers who are under direct supervision of any investigators on the study will not be eligible to participate

Primary outcomes:
measure: Optimize performance
timeFrame: Day of intervention
measure: Compare the signal-to-noise ratio of a custom spine coil with the existing FDA approved posterior coil array used for spine imaging
timeFrame: Day of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT00004331: Studies in Porphyria I: Characterization of Enzyme Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Characterize enzyme defects in patients with known or suspected porphyria and their family members.

II. Determine whether selected patients are eligible for other porphyria research protocols.

III. Provide blood, urine, and fecal samples from well characterized patients and their family members to investigators studying the nature of specific mutations in genes for heme biosynthetic pathway enzymes.

Detailed description: PROTOCOL OUTLINE: All patients are evaluated for porphyria type and factors contributing to the clinical expression of their particular form of the disease. Testing includes erythrocyte porphobilinogen deaminase, erythrocyte protoporphyrin, plasma porphyrins, and urinary and fecal porphyrins and precursors.

Selected patients are entered into other porphyrin research protocols in this and other institutions, including analysis of DNA to identify specific mutations in genes for heme biosynthetic pathway enzymes.

Eligibility criteria: * Suspected or confirmed porphyria
* Adults, children, and family members eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT02321631: Efficacy of EPA-enriched Supplement in Malnourished Head and Neck Cancer Patients Undergone Surgery
Official title: Efficacy of EPA-enriched Supplement Compared With Standard Formula on Body Weight Changing in Malnourished Head and Neck Cancer Patients Undergone Surgery: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Malnourished
Head and Neck Cancer
Surgery
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. Primary outcome is perioperative weight changing.

Detailed description: To study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. The patients are divided into 2 groups receiving the different formula supplements. The both supplements are isocaloric. The patients receive the supplement for 3 weeks (1 week prior to surgery and 2 weeks post surgery) Primary outcome is perioperative weight changing. Secondary outcomes are body compositions, hospital stay days, complication and co-morbidity.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as Head an Neck cancer with pathological confirmation
2. Receiving surgery as a primary treatment
3. Malnutrition screening tool(MST) is 2 or more

Exclusion Criteria:

1. Previously irradiated patient in the Head and Neck region
2. Previously receiving chemotherapy
3. Renal insufficiency with serum creatinine \> 2.5 mg/dL
4. Liver function abnormality with total serum bilirubin \> 3.0 mg/dL
5. Pregnancy

Primary outcomes:
measure: Change from baseline in Body weight at 3 weeks
timeFrame: 3 weeks
measure: Change from baseline in Body weight at 1 month
timeFrame: 1 month
measure: Change from baseline in Body weight at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in fat-free mass percentage at 3 weeks
timeFrame: 3 weeks
measure: Change from baseline in fat-free mass percentage at 1 month
timeFrame: 1 month
measure: Change from baseline in fat-free mass percentage at 3 months
timeFrame: 3 months
measure: Change from baseline in body fat percentage at 3 weeks
timeFrame: 3 weeks
measure: Change from baseline in body fat percentage at 1 month
timeFrame: 1 month
measure: Change from baseline in body fat percentage at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Kitti Jantharapattana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136331: Study of a Pandemic Influenza Vaccine
Official title: Phase Ia Study of a Pandemic Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next avian influenza pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* History of Guillain-Barre syndrome or active neurological disease

Primary outcomes:
measure: Safety and immunogenicity
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, a division of IDT Australia
state: South Australia
city: Melbourne
country: Australia
facility: Murdoch Childrens Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Terry M Nolan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.
Clinical trial NCT01965431: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Official title: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Female and Male Subjects. Randomised, Placebo Controlled, Single-blind, Three-period Crossover Phase-I-study With Moxifloxacin as Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects


Eligibility criteria: Inclusion criteria:

* Healthy male and female subjects
* Subjects must be able to understand and comply with study requirements
* Age =18 and =55 years
* BMI range: =18.5 and =29.9 kg/m2

Exclusion criteria:

- any relevant deviation from healthy conditions

Primary outcomes:
measure: Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
timeFrame: 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1
Secondary outcomes:
measure: Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment
timeFrame: 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1
measure: Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
timeFrame: 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1
measure: Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
timeFrame: 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1241.40.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01154231: BeneFIX Drug Use Results Survey [All-Case Surveillance]
Official title: Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Keywords: BeneFIX Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 314
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Brief summary: The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.

1. Occurrence status of adverse events
2. Factors that may influence the safety
3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.

Detailed description: Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."

Eligibility criteria: Inclusion Criteria:

* All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
* No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.

Exclusion Criteria:

* Patients not administered BeneFIX.

Primary outcomes:
measure: Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy
timeFrame: 2 years for PTPs, 1 year for PUPs
measure: Number of Administrations Required for Hemostasis for Bleeding Events
timeFrame: 2 years for PTPs, 1 year for PUPs
Secondary outcomes:
measure: Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes
timeFrame: 2 years for PTPs, 1 year for PUPs
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01844531: Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Official title: Bioequivalence of Empagliflozin/Metformin (500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects
2. Subjects must be able to understand and comply with study requirements
3. Age 18 to 50 years
4. Body mass index (BMI) 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC0-∞ for Empagliflozin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
measure: AUC0-∞ for Metformin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
measure: Cmax for Empagliflozin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
measure: Cmax for Metformin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
Secondary outcomes:
measure: AUC0-tz for Empagliflozin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
measure: AUC0-tz for Metformin
timeFrame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1276.6.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01060631: Influence of Intracranial Lesions on Bispectral Index
Official title: "Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supratentorial Brain Tumor
Keywords: bispectral index
lesions
consciousness
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.

Brief summary: The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
* Control group: Neurosurgical patients without intracranial pathology.

Exclusion Criteria:

* Patient refusal
* Significantly increased intracranial pressure
* Uncontrolled arterial hypertension
* Significant coronary artery disease
* Anticipated difficult airway
* Decreased level of consciousness
* Existing motor weakness dominant arm/hand
* Impaired hearing
* Nausea, vomiting

Primary outcomes:
measure: Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
timeFrame: one year
Secondary outcomes:
measure: Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
timeFrame: one year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: U Beese, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahinovic MM, Eleveld DJ, Miyabe-Nishiwaki T, Struys MMRF, Absalom AR. Pharmacokinetics and pharmacodynamics of propofol: changes in patients with frontal brain tumours. Br J Anaesth. 2017 Jun 1;118(6):901-909. doi: 10.1093/bja/aex134.
Clinical trial NCT05610631: Pulmonary Hypertension Registry Switzerland
Official title: Swiss PH Registry - Cohort of Swiss PH Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2022-11-09
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Hypertension (PH)

Brief summary: Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes.


Eligibility criteria: Inclusion Criteria:

* Patients with PH

Exclusion Criteria:

-

Primary outcomes:
measure: 6-minute walking distance
timeFrame: within the study duration e.g. up to 10 years
Secondary outcomes:
measure: New York Heart Association functional class
timeFrame: within the study duration e.g. up to 10 years
measure: NTproBNP
timeFrame: within the study duration e.g. up to 10 years
measure: Survival
timeFrame: within the study duration e.g. up to 10 years
measure: Medication
timeFrame: within the study duration e.g. up to 10 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: UniversityHospital Zurich
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: