louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05222581: Engineering Evaluation of a Breast Pump Device
Official title: Engineering Evaluation of a Breast Pump Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Breast Pumping
Lead sponsor: Momtech Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prototype breast shield designs for the Freedom Double Electric Breast Pump with \<10 subjects per breast shield design. The study sample size is appropriate for a small feasibility study evaluating design concepts because there are several breast shield designs being evaluated with a small number of subjects per design.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.

Detailed description: This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.

Eligibility criteria: Inclusion Criteria:

* History of good health
* Currently lactating and planning to continue breastfeeding for the next 3 to 4 months
* Currently using a commercial electric breast pump at least several times a week
* Sufficient milk supply for one missed infant feeding per device testing visit
* Willing to attend five device testing visits over 3 to 4 months
* Willing to be video recorded during device testing
* Willing to discard milk collected during testing

Exclusion Criteria:

* No active breast or nipple injury, breast inflammation or infection, or nipple piercing
* No prior history of breast implant, reduction or reconstruction surgery
* Not currently pregnant

Primary outcomes:
measure: Breast shield comfort
timeFrame: 1 day (Single timepoint)
measure: Breast shield fit
timeFrame: 1 day (Single timepoint)
measure: Breast shield ease of use
timeFrame: 1 day (Single timepoint)
Secondary outcomes:
measure: Volume of milk expressed
timeFrame: 1 day (Single Timepoint)
measure: Participant comparison of device to current commercial breast pump
timeFrame: 1 day (single timepoint)
measure: Participant comparison of device to breastfeeding
timeFrame: 1 day (single visit)
Other outcomes:
Locations:
city: Cary
country: United States
facility: Blur Product Development
state: North Carolina
Study officials:
affiliation: Independent Physician
name: Ashley Wofford Leong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421381: RHODOS Follow-up Single-visit Study
Official title: A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leber's Hereditary Optic Neuropathy
Keywords: leber's hereditary optic neuropathy
idebenone
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in study SNT-II-003

Brief summary: This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.


Eligibility criteria: Inclusion Criteria:

* Previous participation in study SNT-II-003

Primary outcomes:
measure: logMAR visual acuity
timeFrame: measure taken at the single study visit (Week 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal,
country: Canada
facility: Hôpital Notre-Dame (CHUM)
state: Quebec
city: München
country: Germany
facility: Friedrich Baur Institut Neurologische Klinik und Poliklinik
city: Newcastle upon Tyne
country: United Kingdom
facility: Biomedical Research Centre, The Medical School
Study officials:
affiliation: Clinical Research Facility
name: Patrick Chinnery, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy. Brain. 2011 Sep;134(Pt 9):2677-86. doi: 10.1093/brain/awr170. Epub 2011 Jul 25.
citation: Klopstock T, Metz G, Yu-Wai-Man P, Buchner B, Gallenmuller C, Bailie M, Nwali N, Griffiths PG, von Livonius B, Reznicek L, Rouleau J, Coppard N, Meier T, Chinnery PF. Persistence of the treatment effect of idebenone in Leber's hereditary optic neuropathy. Brain. 2013 Feb;136(Pt 2):e230. doi: 10.1093/brain/aws279. Epub 2013 Feb 6. No abstract available.
Clinical trial NCT00602381: Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
Official title: A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinicl trial within 30 days prior to study initiation.
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Three period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Research
state: Arkansas
Study officials:
affiliation: Arkansas Research
name: Jerry Herron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643681: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lumbar Intervertebral Disc Degeneration
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: Korea University Anam Hospital
First posted: 2012-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
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 is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.


Eligibility criteria: Inclusion Criteria:

* Subjects who understand and sign the consent form for this study
* Age :19-70, males and females
* Have chronic low back pain for at least 1 year
* Have failed 1 year of non-operative low back pain management
* Have degenerated intervertebral disc on T2-weighted MR images
* confirmed by positive discography
* Have significant lumbar instability at degenerated intervertebral disc

Exclusion Criteria:

* Have significant lumbar herniated intervertebral disc
* Women who are pregnant or breast feeding or planning to become pregnant during the study
* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Primary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes of Neurological Functions
timeFrame: 24 weeks
measure: Safety evaluation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT04465981: Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients
Official title: A Longitudinal, Non-randomized Study to Evaluate the Utility of the INanoBio's Protein Arrays in Detecting Unique Antibodies in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS-CoV-2 Infection
Lead sponsor: INanoBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: TMC HealthCare
First posted: 2020-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 tested patients

Brief summary: SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment.

The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable.

Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.

Detailed description: A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The goal will be to assess antibodies throughout the subject's disease course compared to controls.

Eligibility criteria: Inclusion Criteria:

Subject must meet all of the following criteria to be eligible for treatment in the study:

1. Subject or legal representative understands the nature of the procedure and has signed the Subject Informed Consent Form prior to study procedures
2. For the COVID-19 Cohort

   * Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR
3. For the PUI Cohort

   * Subject has suspected COVID-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested negative by RT-PCR)

Exclusion Criteria:

* Subject or legal representative not willing to consent

Primary outcomes:
measure: Serological identification of individuals who have been infected with SARS-CoV-2
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Identify antibody and/or immune signatures in COVID-19 patients
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: TMC HealthCare
state: Arizona
Study officials:
affiliation: TMC HealthCare
name: Katherine Scott
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594081: Use of Podcasts in Nursing Education
Official title: Use of Podcasts in Nursing Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Students
Keywords: nursing student
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Use of Podcasts in Nursing Education: A Randomized Controlled Trial


Eligibility criteria: Inclusion Criteria:

* Students who use Spotify
* Those who have a smart phone
* Those who have enough internet connection to listen to podcasts on Spotify
* Students taking the Fundamentals of Nursing course for the first time
* Students who are not horizontal/vertical transfer students
* Students who have not graduated from Health Vocational High School
* Those who were not absent during the study were included in the study.

Exclusion Criteria:

* Students who were not first-year nursing students
* Students who did not use Spotify
* Students who came via horizontal/vertical transfer
* Students who graduated from Health Vocational High School
* Students in the intervention group who did not listen to podcasts on Spotify
* Students in the control group who were understood to have logged into their Spotify accounts and listened to podcasts were excluded from the study.

Primary outcomes:
measure: Motivation Scale Related to Instructional Material
timeFrame: 6 months
Secondary outcomes:
measure: "Achievement Test 1" and "Achievement Test 2"
timeFrame: 6 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Bahar Çiftçi
Study officials:
affiliation: Ataturk University
name: Bahar Çiftçi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03392181: PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Official title: PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2018-01-05
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.


Eligibility criteria: Inclusion Criteria

* Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer
* Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)
* Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2
* Patients must be age ≥ 18 years
* Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging
* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

* Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)
* Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan
* Patients may not be receiving any other treatments or investigational agents
* Patients with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria
* Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
* Patients who have received androgen deprivation therapy or prior surgery for prostate cancer
* Patients who report taking multivitamins and/or folate supplements on the day of the scan

Primary outcomes:
measure: PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Chair, Department of Urology
name: Edward Schaeffer, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707081: Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
Official title: Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postcesarean Pain Relief
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.

Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications

Exclusion Criteria:

* extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI \>35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.

Primary outcomes:
measure: Postoperative pain scoring (number)
timeFrame: First 24 hours postoperative
Secondary outcomes:
measure: The need for rescue postoperative analgesia.
timeFrame: First 24 hours postoperative
measure: Total pethidine consumption in 24 hours (mg)
timeFrame: First 24 hours postoperative
measure: The time to bowel sounds, hours
timeFrame: First 3 days postoperative
measure: The time to start regular diet, days
timeFrame: First 3 days postoperative
measure: Duration of hospital stay , days
timeFrame: First 3 days postoperative
measure: Any reported side effects
timeFrame: First 3 days postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01869881: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)
Official title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 151
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.


Eligibility criteria: Inclusion Criteria:

* person who signed on ICF
* Type 2 diabetic patient who have microalbuminuria or overt proteinuria
* In case of hypertension patients, who keep the same medication steadily over last 4 weeks

Exclusion Criteria:

* patients who have hypersensitivity on sarpogrelate or other salicylic acid
* patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
* patients who took other anticoagulant agent within 1 month
* patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
* Type 1 diabetes patients
* Patient who have cardiac or liver problem
* Cr: \>1.8mg/dl or GFR: \<40ml/min
* malignant tumor patients

Primary outcomes:
measure: ACR(Urine Albumin/Creatinine ratio)
timeFrame: treatment period(24 weeks)
Secondary outcomes:
measure: ACR(Urine Albumin/Creatinine ratio)
timeFrame: Treatment period(24 weeks)
measure: urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen
timeFrame: treatment period(24 weeks)
measure: ACR(Urine Albumin/Creatinine ratio)
timeFrame: treatment period(24 weeks)
measure: ACR(Urine Albumin/Creatinine ratio)
timeFrame: treatment period(24 weeks)
measure: Creatinine
timeFrame: treatment period(24 weeks)
measure: PCR(Protein to Creatinine ratio in Urine)
timeFrame: treatment period(24 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University, Anam
Study officials:
affiliation: Korea University Hospital, Anam
name: D.S Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.