louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02429102: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy subjects
Pharmacokinetics of MT-8554
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
* A body weight of ≥60 kg male and ≥50 kg female

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values

Primary outcomes:
measure: Safety and Tolerability as measured by vital signs
timeFrame: up to Day14
measure: Safety and Tolerability as measured by ECG
timeFrame: up to Day14
measure: Safety and Tolerability as measured by continuous lead II ECG monitoring
timeFrame: up to Day14
measure: Safety and Tolerability as measured by laboratory safety assessments
timeFrame: up to Day14
measure: Safety and Tolerability as measured by physical examination
timeFrame: up to Day14
measure: Safety and Tolerability as measured by number of participants with adverse events
timeFrame: up to Day14
Secondary outcomes:
measure: PK profile (Cmax, tmax, t½, AUC)
timeFrame: 240 hours post dose
Other outcomes:
Locations:
city: City name
country: United Kingdom
facility: Investigational center
Study officials:
References:
Clinical trial NCT01461902: Vasospasm in Pediatric Traumatic Brain Injury
Official title: Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Keywords: traumatic brain injury
brain injury
head injury
vasospasm
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.

Brief summary: The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.


Eligibility criteria: Inclusion Criteria:

1. admission to Duke University Children's Hospital;
2. age 5 days to 15 years;
3. a diagnosis of a TBI with a GCS 3-15;
4. capable of adequate TCD ultrasound examination;
5. and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.

Exclusion Criteria:

* the presence of previously diagnosed significant neurodevelopmental delay,
* a diagnosis of non-traumatic intracranial hemorrhage and
* parents/legal guardians who do not speak or understand English.

Primary outcomes:
measure: Vasospasm detection by Transcranial Doppler Ultrasound
timeFrame: 8 days
Secondary outcomes:
measure: Detection of biomarkers in pediatric traumatic brain injury
timeFrame: 2 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing and School of Medicine
name: Karin Reuter-Rice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639002: A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
Official title: A Phase 2, Two Stage, Open-label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.

Detailed description: The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma with evidence of measurable disease.
* Relapsed or refractory disease with at least one line of prior therapy.
* Adequate bone marrow reserve.

Exclusion Criteria:

* Received anti-cancer medications or investigational therapy in the past 28 days.
* Intracranial disease or epidural disease.

Primary outcomes:
measure: Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma
timeFrame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Secondary outcomes:
measure: Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma
timeFrame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Other outcomes:
Locations:
city: Highland
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: New York
country: United States
state: New York
Study officials:
affiliation: St. Vincent's Comprehensive Cancer Center, New York, New York
name: Sundar Jagannath, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02576002: Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
Official title: Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 2691
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be all patients who were born after 1991 and thus under the age of 18 during the years 2010 to 2013 in the MarketScan data. The larger population of patients under age 18 will comprise the general population from which population-based prevalence rates will be derived.

Brief summary: To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013


Eligibility criteria: Inclusion Criteria:

* All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Incidence rate of PAH (pulmonary arterial hypertension)
timeFrame: Retrospective analysis of three year period
measure: Prevalence rate of PAH
timeFrame: Retrospective analysis of three year period
Secondary outcomes:
measure: Assigned drug treatment for PAH measured using the MarketScan database
timeFrame: Retrospective analysis of three year period
measure: Diagnostic procedures performed among PAH patients measured using the MarketScan database
timeFrame: Retrospective analysis of three year period
measure: Prevalence of comorbidities among PAH patients
timeFrame: Retrospective analysis of three year period
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01936402: Instruction to Compress Chest Approximately 6-7cm for Healthcare Provider in Hospital
Official title: Novel Instruction to Perform Chest Compression Approximately 6-7cm for Healthcare Provider Improves Chest Compression Depth During Cardiopulmonary Resuscitation in Hospital.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiopulmonary Resuscitation
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Unlikely the other element for high quality chest compression during Cardiopulmonary resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth (CCD) is influenced by surface on which the patient is placed, especially in hospital. For solving this problem, to place the patient on rigid surface, use a backboard that might decrease the mattress compression, receive a feedback that reflects the mattress compression depth (MCD) using dual accelerometer or magnetic sensor have been proposed. As the other solution, we hypothesized that training of 6-7cm CCD for healthcare providers improve accurate CCD during cardiopulmonary resuscitation when manikin is placed on mattress in hospital.


Eligibility criteria: Inclusion Criteria:

* Medical students, Healthy

Exclusion Criteria:

* Heart, wrist, and low back disease

Primary outcomes:
measure: Change of Chest compression depth at 4 weeks
timeFrame: 1 hour and 4weeks later after education
Secondary outcomes:
measure: Change of Chest compression rate at 4 weeks
timeFrame: 1 hour and 4weeks later after education
Other outcomes:
measure: Change of number of Chest decompression at 4 weeks
timeFrame: 1 hour and 4weeks later after education
Locations:
Study officials:
References:
Clinical trial NCT06057402: Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
Official title: ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Elranatamab
Post Trial Access
Roll-over Study
Extension Study
MM-15
MagnetisMM15
BCMA
BCMA antibody
Magnetism
Bispecific antibody
Elrexfio
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Detailed description: This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Eligibility criteria: Inclusion Criteria:

* Participants must agree to follow the reproductive criteria as outlined in the protocol
* Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

Primary outcomes:
measure: Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
timeFrame: A minimum of 90 days after the last dose of study drug
measure: Incidence of serious adverse events (SAEs)
timeFrame: A minimum of 90 days after the last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01042002: Effect of Exercise Before Gastric Bypass
Official title: Effect of Exercise Before Gastric bypass-a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: High intensity exercise
morbid obesity
gastric bypass
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.

The aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Age: \> 20 years
* BMI: \> 40 or \> 35 with comorbidity
* Resident: Sør Trøndelag

Exclusion Criteria:

* Unstable Angina
* Resent cardiac infarction (within last year)
* heart failure
* Uncontrolled hypertension
* cardiomyopathy

Primary outcomes:
measure: Hospitalization days after gastric bypass
timeFrame: Baseline, pre-operation and 6 months post operation
Secondary outcomes:
measure: Complications after gastric bypass
timeFrame: 6 months post operation
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegain University of Science and Technology
name: Arnt E Tjonna, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06733402: A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.

Detailed description: A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
* Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
* Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.
* Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
* Subjects with a baseline irritation score of 3 = severe (marked, intense).

Primary outcomes:
measure: Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: Taro Pharmaceuticals, Inc.
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT00811902: Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
Official title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 405
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: The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).

Secondary objectives:

* To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator
* To assess the safety and tolerance of nerispirdine
* To evaluate the pharmacokinetics (PK) parameters of nerispirdine

Detailed description: Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period

Eligibility criteria: Inclusion Criteria:

* Clinically definite MS (according to McDonald criteria),

Exclusion Criteria:

* Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.
* Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,
* Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
* Female patients who are either pregnant or breastfeeding.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
timeFrame: 14 weeks
Secondary outcomes:
measure: Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-aventis Administrative Office
state: New Jersey
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-aventis Administrative Office
city: Lysaker
country: Norway
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: