louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01575483: Korean Post-marketing Surveillance for Onglyza®
Official title: Korean Post-marketing Surveillance for Onglyza®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 3433
Sex: ALL
Minimum age (years): 18
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 diagnosis of type 2 diabetes mellitus initiating Onglyza® treatment within the approved indications will be enrolled

Brief summary: The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.


Eligibility criteria: Inclusion Criteria:

* Female and male patients who are at least 18 years of age
* Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea

Exclusion Criteria:

* Indication which is not approved for Onglyza® in Korea
* Patients with contraindication for the use of Onglyza® (as clarified in Korean label)

Primary outcomes:
measure: Adverse events occurrence
timeFrame: 30 days after last dose of study drug
Secondary outcomes:
measure: Number of Adverse Events and Serious Adverse Events
timeFrame: 30 days after last dose of study drug
measure: Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data
timeFrame: Baseline (Week 0), 12 weeks and 24 weeks of registration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04995783: Predicting Medication Response for Autoimmune Disease
Official title: Predicting Medication Response for Autoimmune Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ulcerative Colitis
Crohn's Disease
Psoriasis
Rheumatoid Arthritis
Lead sponsor: Coral Genomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2021-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include adults 18 years and older who have been diagnosed with one of the four autoimmune conditions.

Brief summary: Coral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients.

Patients with Inflammatory Bowel Disease (IBD) who have been diagnosed with either Ulcerative Colitis or Crohn's Disease and are undergoing treatment are eligible to participate.

Patients with Rheumatoid Arthritis (RA) and Psoriasis (Ps) will also be enrolled.

A novel clinical test will be performed to predict the responsiveness of a particular patient to different immune modulating therapies used in these conditions.


Eligibility criteria: Inclusion Criteria:

* Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis
* On or about to begin a treatment for condition above

Primary outcomes:
measure: Prediction of medication response
timeFrame: retrospective and 6 months prospectively
Secondary outcomes:
measure: Prediction of disease severity
timeFrame: at enrollment
measure: Classification of disease
timeFrame: at enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Coral Genomics, Inc.
state: California
Study officials:
References:
Clinical trial NCT03559283: fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
Official title: Using Functional Near-infrared Spectroscopy (fNIRS) in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: D020521
Keywords: stroke, dual-task, gait parameters, fNIRS
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 11
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.

Detailed description: Walking is a motor task that involves cognitive functions. The parameters of walking and brain activity are modified in situations requiring significant attentional and cognitive demand. fNIRS is an interesting functional neuroimaging technique for studying cortical activity when performing a Dual Task (DT). To our knowledge, no studies have examined cerebral oxygenation levels in post-stroke patients based on different cognitive loads during walking. Understanding cognitive contributions in a dual-task walking situation is necessary to providing targeted interventions and preventing falls.

Patients included in the study will be evaluated in single cognitive task, with two levels of difficulty, single walking motor task, and dual task with two levels of cognitive difficulty. The fNIRS will record the hemodynamic activity of the prefrontal cortex for the cognitive slope and the GAITRite will record the walking parameters.

Eligibility criteria: Inclusion Criteria:

* patient between 55 and 75 years old
* First stroke
* ischemic sylvian or hemorrhagic lobar deep respecting the frontal lobe, subacute phase (J15-J90),
* patient walking 10 meters.

Exclusion Criteria:

* Heminegligencia,
* a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.

Primary outcomes:
measure: Cost of the Double Task
timeFrame: Day of the Inclusion
Secondary outcomes:
measure: Impact of the double task on spatio-temporal parameters of walking and on cognition
timeFrame: Day of the Inclusion
measure: Evaluate the asymmetry of cerebral activation in different walking conditions
timeFrame: Day of the Inclusion
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05678283: A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors
Official title: A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: CC-90010
Neoplasms
Solid Tumors
[14C]CC-90010
BMS-986378
BET Inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Males ≥ 18 years of age
* Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

Exclusion Criteria:

* Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
* History of concurrent second cancers requiring active and ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable)
timeFrame: Up to 26 Days
measure: Cumulative elimination of total [14C]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomit, if applicable)
timeFrame: Up to 14 Days
measure: Total [14C]-radioactivity whole blood to plasma ratios
timeFrame: Up to 26 Days
measure: Peak plasma drug concentration (Cmax)
timeFrame: Up to 26 Days
measure: Time to peak plasma drug concentration (Tmax)
timeFrame: Up to 26 Days
measure: Area under the concentration-time curve from time zero to time the time of the last measurable concentration (AUC[0-T])
timeFrame: Up to 26 Days
Secondary outcomes:
measure: Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces
timeFrame: Up to 26 Days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 26 Months
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 26 Months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 26 Months
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 26 Months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 26 Months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Local Institution - 0002
state: M
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00255983: A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
Official title: Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Bronchitis
Keywords: bronchitis
AECB
Lead sponsor: Replidyne
Sponsor class: INDUSTRY
Collaborators: name: INC Research Limited
First posted: 2005-11-21
Enrollment: 491
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.

Detailed description: This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation

Exclusion Criteria:

* Gold criteria III

Primary outcomes:
measure: • Clinical response at test of cure.
timeFrame: Day 8 to 12
Secondary outcomes:
Other outcomes:
Locations:
city: New Hope
country: United States
facility: Multicenter
state: Pennsylvania
Study officials:
affiliation: Replidyne, Inc.
name: Roger M Echols, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04484883: Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes
Official title: Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)

Brief summary: The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard

Detailed description: All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured REE was not available or if presenting with conditions known to affect indirect calorimetry.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Available resting energy expenditure assessed by indirect calorimetry

Exclusion Criteria:

* data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved
* presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR \< 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)

Primary outcomes:
measure: Body weight
timeFrame: Baseline
measure: Neck circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: At baseline
measure: Hip circumference
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: At baseline
measure: Resting Energy Expenditure (REE)
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Gastroenterology IRCCS S. de Bellis
state: Bari
Study officials:
References:
Clinical trial NCT02434783: The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity
Official title: The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Claudication
Keywords: Blood circulation
Blood vessels
Mitochondria
Muscle, skeletal
Legs
Energy metabolism
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-05-05
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with arterial insufficience at 1 of three levels, either asymptotic, intermittent claudication or critical limb ischemia; and healthy persons in a control group

Brief summary: Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles.

This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.


Eligibility criteria: Inclusion Criteria:

* Asymptotic peripheral arterial disease (Ankle-brachial index \< 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index \< 0.4)

Exclusion Criteria:

* Diagnosed with intermittent claudication secondary to vascular insufficiency
* Warfarin or heparin usage
* Underwent a vascular intervention in the last 6 months
* Active cancer, renal- or liver disease

Primary outcomes:
measure: mitochondrial respiratory capacity
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øyvind Rognmo
role: STUDY_DIRECTOR
References:
Clinical trial NCT04782583: Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study
Official title: Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cup
Intrauterine Device Migration
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-04
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an intrauterine device for contraception.

Brief summary: In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (\<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over
* Consultant for one of the following reasons:

  * IUD control
  * IUD expulsion
  * Pregnancy on IUD
  * Other reason that required an ultrasound for the IUD
* Consent to participate in the study

Exclusion Criteria:

* Patient benefiting from a legal protection measure

Primary outcomes:
measure: Evaluating the risk of IUD displacement in patients using menstrual cup
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: cabinet IPSO
Study officials:
References:
Clinical trial NCT05961683: Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
Official title: Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Apnea of Newborn
Lead sponsor: Keck School of Medicine of USC
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU


Eligibility criteria: Inclusion Criteria:

* Gestation Age of 23-41 weeks
* Born at LAC+USC Medical Center and admitted to NICU
* Received NIPPV or nasal CPAP

Exclusion Criteria:

* Infants with any congenital anomalies
* Infants receiving only comfort care measures.
* Infants receiving invasive mode of mechanical ventilation (intubated)
* Non-inborn neonates
* Re-admissions to the NICU

Primary outcomes:
measure: interventions performed while using NIV plus software
timeFrame: 24 hours
Secondary outcomes:
measure: difference in pressures set and received
timeFrame: 12 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
Study officials:
References: