louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04639583: Use of NIRS in Preterm Population Born at Altitude
Official title: Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity; Extreme
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.


Eligibility criteria: Inclusion Criteria:

* Infant must be \<32 weeks' gestational age at time of delivery.
* Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
* Infants that require blood transfusions during the monitoring time may be included.

Exclusion Criteria:

* Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
* Infant born after placental abruption or concern for extreme blood loss immediately after birth.
* Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
* Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
* Mothers/guardians that are \<18 years of age will not be approached for consent.
* Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study.
* Any infant that is planned to be placed for adoption
* Infant is greater than 24 hours of age at time of consent.

Primary outcomes:
measure: Cerebral Regional Oxygen Saturation (cRSO2)
timeFrame: first 96 hours of life
Secondary outcomes:
measure: Incidence of Major Complications of Prematurity
timeFrame: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References:
Clinical trial NCT00879983: An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
Official title: An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: azithromycin, pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-13
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers.
* Male.
* 18-45 years old.
* BMI 17.5-30.5 kg/m2.

Exclusion Criteria:

* Alcohol, drug, smoke user.
* Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.

Primary outcomes:
measure: AUC inf (if data permit) and AUC last of azithromycin
timeFrame: 2 months
Secondary outcomes:
measure: AUC 24, Cmax, Tmax, t1/2 of azithromycin
timeFrame: 2 months
measure: vital signs, 12-lead ECG, laboratory tests and adverse events.
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02083783: TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.

Detailed description: A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria:

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Primary outcomes:
measure: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)
timeFrame: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose
Secondary outcomes:
measure: PERMP (Permanent Product Measure of Performance).
timeFrame: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Bayou City Research
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigation
state: Texas
Study officials:
affiliation: Newport Beach Clinical Research Associates, Inc.
name: Sharon Wigal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05270083: Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
Official title: Role of NeuraceqTM (Florbetaben F18 Injection) PET in Young Athletes With and Without Persistent Cognitive Complaints Following Multiple Concussions: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.

Detailed description: Former college athletes who sustained at least one previous concussion will undergo computerized neurocognitive testing and a structured questionnaire of present symptoms. \[F-18\] Florbetaben PET images will be acquired dynamically, with data binned in 20 time frames of 1 min each (early phase), followed by 4 frames of 5 min each (late phase), with image frames summed within each phase after linearly coregistering to subjects' mean images, then elastically transformed to template space of a florbetaben scan used in standardized volume of interest quantification, and intensity normalized to mean voxel value within each phase.

Eligibility criteria: Inclusion Criteria:

* 18-40 years of age
* A minimum of 1 concussion prior to study entry
* A minimum of one year post first concussion
* mTBI as defined by the American Congress of Rehabilitative Medicine
* Participants in Cohort A must have either subjective or objective evidence of persistent cognitive deficits

Exclusion Criteria:

* Impaired decision-making capacity, i.e. inability to provide informed consent
* Pregnancy
* History of other neurologic disorders (e.g., epilepsy, cerebrovascular disease, neurodegenerative disorders, intellectual disability)
* Significant systemic medical illness
* Current DSM-IV Axis I diagnosis of psychiatric illness

Primary outcomes:
measure: Neuraceq™ PET Imaging
timeFrame: Up to 90 minutes after injection
measure: Cognitive Assessment_1
timeFrame: within 24 hours of [F-18]Florbetaben PET imaging
measure: Cognitive Assessment_2
timeFrame: within 24 hours of [F-18]Florbetaben PET imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Marc A Seltzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926483: Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
Official title: A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage IIIA
Keywords: Stage IIIA-N2 NSCLC
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.

Detailed description: Scheme:

Patients will receive different chemotherapy regimens depending on the pathological type.

Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.

Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.

Eligibility criteria: Inclusion Criteria:

* 18≤Age≤65;
* ECOG performance status of 0 or 1;
* Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
* WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
* Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
* The patient can understand the research and sign the informed consent.

Exclusion Criteria:

* Female in pregnancy or lactating;Female of childbearing age without contraception;
* With acute infection or other serious underlying disease;
* With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
* Have received other treatment within the last 30 days before enrollment;
* With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).

Primary outcomes:
measure: PFS
timeFrame: up to 3 years
Secondary outcomes:
measure: Adverse events
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
measure: QOL
timeFrame: up to 3 years
measure: OS
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Weimin Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04586361: Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
Official title: Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PRP
ACL
Hyaluronic Acid
Keywords: PRP; ACL reconstruction
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.

Methods:

The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.

Follow-up:

Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.


Eligibility criteria: Inclusion Criteria:

* receiving unilateral ACL reconstruction in our hospital
* postoperative follow-up over 3 month

Exclusion Criteria:

* postoperative follow-up less than 3 month
* possible pregnency
* with coagulation disease
* NSAIDs intake during study period

Primary outcomes:
measure: 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
timeFrame: postoperative 1 month
measure: 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
timeFrame: postoperative 3 months
measure: 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
timeFrame: postoperative 12 months
measure: 150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
timeFrame: postoperative 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: 高雄市
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Yi Ping Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254461: A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin
Official title: A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction
Keywords: Phase 1
Drug-Drug interaction
pravastatin
AZD1981
The pharmacokinetics resulting from AZD1981 and pravastatin interaction
The effects of taking a combination of AZD1981 and pravastatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18 to 55, inclusive
* Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination

Primary outcomes:
measure: Pharmacokinetics for pravastatin measured by Cmax and AUC
timeFrame: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Secondary outcomes:
measure: AUC
timeFrame: PK sampling will be performed on Day 1, period A and on Day 7-8, period B
measure: AUCτ
timeFrame: PK sampling will be performed on Day 7 and Day 8, period B
measure: Safety and tolerability
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
References:
Clinical trial NCT03140761: The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
Official title: The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2017-05-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 78 hospitalised patients with exacerbation of COPD

Brief summary: To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.

Detailed description: COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.

Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years
* Caucasian classified with COPD
* Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)

Exclusion Criteria:

* Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
* Pregnancy or lactation
* on regular systemic glucocorticoid therapy before admission to the hospital
* People who are detained under the act on the use of coercion in psychiatry
* Severe language problems or inability to provide written informed consent

Primary outcomes:
measure: Secondary Adrenal insufficiency
timeFrame: average 1 month
Secondary outcomes:
measure: Metabolic syndrome
timeFrame: average 1 month
measure: Bone mineral loss
timeFrame: average 1 month
measure: Onset of Diabetes Mellitus
timeFrame: average 1 month
measure: Quality of life
timeFrame: average 1 month
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal medicine, Herlev & Gentofte Universtity Hospital
Study officials:
References:
Clinical trial NCT01011361: Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia
Official title: Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient elderly men and women (aged 65 years or older) with anemia, also enrolled in the "Anemia in the Elderly" NCT00640172 study.

Brief summary: On the basis that the clinical consequences of seemingly trivial levels of anemia are surprisingly severe, this study investigates if hemoglobin concentration accurately represents the underlying red cell mass in elderly patients with unresolved anemia.

Detailed description: For the study, the routine clinical measurement of hemoglobin will be compared to true red cell mass and plasma volume in elderly patients with anemia.

Eligibility criteria: INCLUSION CRITERIA:

* 65 and older
* Anemia (hemoglobin \< 13 g/dL in men or \< 12 g/dL in women)
* Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System

EXCLUSION CRITERIA:

* Body mass index (BMI):

  * \< 18.5 kg/m2
  * \> 35 kg/m2
* Palpable splenomegaly
* Contraindication to RBC mass/plasma volume testing
* On any experimental pharmacologic agent in the prior 2 months

Primary outcomes:
measure: Red blood cell mass
timeFrame: 1 day
Secondary outcomes:
measure: Plasma volume measurements
timeFrame: 1 day
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Stanley L Schrier, MD
role: PRINCIPAL_INVESTIGATOR
References: