louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01795625: OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China
Official title: A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Glucose Measurement
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of at least 240 diabetic subjects (type 1 or type 2) study-wide at two clinical sites.

Brief summary: The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
* Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
* Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.

Exclusion Criteria:

* Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
* Subject has already participated in this study.
* Subject is known pregnant

Primary outcomes:
measure: • Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
timeFrame: 56days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Yongde Peng, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiaotong University, medical school affiliated Third People's Hospital
name: Fengling Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690725: TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
Official title: Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Safety Issues
Efficacy, Self
Keywords: osteosarcoma
ewing sarcoma
chondrosarcoma
PI3KA mutation
PTEN loss
TQB3525
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: TQB3525 orally taken
Primary purpose: TREATMENT

Brief summary: The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.


Eligibility criteria: Inclusion Criteria:

* progression upon first-line chemotherapy;
* with target lesions according to RECIST 1.1;
* geno-profiling with PI3KA mutations or PTEN loss;
* ECOG PS status 0 or 1 with a life expectancy \>3 months;
* adequate renal, hepatic, and hematopoietic function;

Exclusion Criteria:

* been previously exposed to other TKIs;
* had central nervous system metastasis;
* had other kinds of malignant tumors at the same time;
* had cardiac insufficiency or arrhythmia;
* had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on;
* had pleural or peritoneal effusion that needed to be handled by surgical treatment;
* had other infections or wounds;
* pregnant or breastfeeding.

Primary outcomes:
measure: toxicity profiles
timeFrame: 6 months
Secondary outcomes:
measure: progression free survival
timeFrame: 6 months
measure: overall survival
timeFrame: 2 years
Other outcomes:
measure: fasting triglyceride
timeFrame: 6 months
measure: fasting lipoprotein
timeFrame: 6 months
measure: fasting insulin
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: Peking University Shougang Hospital
Study officials:
affiliation: Chinese Sarcoma Study Group
name: Wei Guo, Ph.D and M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05089825: Telehealth & HPV Self-Collection
Official title: Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Pap Smear
Human papillomavirus
Telehealth
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Oregon Health and Science University
First posted: 2021-10-22
Enrollment: 131
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.

Detailed description: This will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.

Eligibility criteria: Inclusion Criteria:

* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines.
* Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus.

Exclusion Criteria:

* Individuals without a cervix
* Have had prior pelvic radiation therapy or brachytherapy
* Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment
* Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening
* Adults who are unable to consent or are decisionally impaired
* Individuals who are not English speaking

Primary outcomes:
measure: Proportion of participants preferring self-collection to provider collection
timeFrame: Post-intervention: 2 weeks after receipt of test results
Secondary outcomes:
measure: Median perceived difficulty understanding self-collection instructions
timeFrame: Post-intervention: 2 weeks after receipt of test results
measure: Median discomfort level with self-collection
timeFrame: Post-intervention: 2 weeks after receipt of test results
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Amanda Bruegl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368925: Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck
Official title: Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Keywords: Rhytids
Skin Laxity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2015-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.

Detailed description: Before Treatment:

The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score

Treatment:

The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200\~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.

Post-Treatment:

All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health
* Subjects who desire improvement in neck skin

Exclusion Criteria:

* Presence of an active systemic infectious disease
* general disease or skin disorder in the area to be treated
* Pregnant or lactating subjects
* Previous episode of facial or neck surgery for wrinkle correction
* Subjects who have aesthetic addiction, drug abuse, alcohol abuse
* Subjects who were treated Botox or Filler at the neck area
* Subjects who had Auto-Immune disease

Primary outcomes:
measure: Investigator Assessment of Improvement at 12 weeks post-treatment
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: Subject Assessment of Improvement at 12 weeks post-treatment
timeFrame: 12 weeks post-treatment
measure: Subjects' Assessment of Pain during treatment
timeFrame: Subjects were assessed for the duration of study treatment
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do,
Study officials:
affiliation: Seoul National University Bundang Hospital
name: ChangSik Pak, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983825: Impact of CPAP Level on V/Q Mismatch in Premature Infants
Official title: Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Respiratory Insufficiency Syndrome of Newborn
Keywords: CPAP
Bronchopulmonary Dysplasia
Ventilator Induced Lung Injury
V/Q mismatch
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2016-12-06
Enrollment: 21
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.


Eligibility criteria: Inclusion Criteria:

1. Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
2. Age limits: 24 hours of age - 35 weeks corrected gestational age.
3. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
4. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet.

Exclusion Criteria:

1. Congenital anomalies, as determined by the clinical supervising physician.
2. Current or prior air leak syndrome, as determined by the clinical supervising physician.

Primary outcomes:
measure: Ventilation/Perfusion Mismatch
timeFrame: variable; up to 2 hours
Secondary outcomes:
measure: Best CPAP Level
timeFrame: variable, up to 2 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hosptital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nicolas Bamat, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bamat NA, Orians CM, Abbasi S, Morley CJ, Ross Russell R, Panitch HB, Handley SC, Foglia EE, Posencheg MA, Kirpalani H. Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):188-193. doi: 10.1136/archdischild-2022-324474. Epub 2022 Sep 14.
Clinical trial NCT02142725: Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
Official title: Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of ulcerative colitis
* Active ulcerative colitis disease extent ≥ 15 cm
* Active disease despite treatment with mesalamine

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
* Toxic megacolon or fulminant colitis
* Colon resection
* Evidence of infectious colitis
* Celiac disease
* Bleeding hemorrhoids
* History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
* Any severe concomitant renal, endocrine, or psychiatric disorder
* Any relevant known systemic disease
* History of cancer in the last five years
* Abnormal hepatic function or liver cirrhosis
* Abnormal HbA1c at screening visit
* Patients with known hypersensitivity to soy
* Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
* Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
* Treatment with other investigational drug
* Existing or intended pregnancy or breast-feeding

Primary outcomes:
measure: Rate of clinical remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of patients with clinical improvement
timeFrame: 12 weeks
measure: Time to first resolution of symptoms
timeFrame: 12 weeks
measure: Number of stools per week
timeFrame: 12 weeks
measure: Number of days with urgency per week
timeFrame: 12 weeks
measure: Rate of mucosal healing
timeFrame: 12 weeks
measure: Rate of histologic remission
timeFrame: 12 weeks
measure: Physician's global assessment at final visit
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Frankfurt a.M.
country: Germany
facility: Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Study officials:
affiliation: Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
name: Axel Dignass, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858325: Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
Official title: A Two Cohort, Open Label, Single and Multiple Dose Pharmacokinetic Study of 4mg/Kg and 6mg/Kg Doses of Daptomycin in Healthy Chinese Subjects Living in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cubicin
PK
China Registration
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.


Eligibility criteria: Inclusion Criteria:

* Men or women (not of childbearing potential) of Chinese ethnicity
* Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2
* Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive

Exclusion Criteria:

* Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit
* CPK \> 2X ULN (upper limit of normal)

Primary outcomes:
measure: Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9.
timeFrame: On therapy evaluation on Day1~9.
Secondary outcomes:
measure: Safety parameters (Incidence of AEs and SAEs, Deaths, Premature discontinuation due to an AE, regardless of relationship to study medication; Clinical lab data; Vital signs; ECG; Physical exam findings; Concomitant medications and adjunctive procedures).
timeFrame: On therapy evaluation on Day1~9.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
Study officials:
affiliation: AZ Pharmaceuticals - China
name: Gang Chen, MD
role: STUDY_CHAIR
affiliation: Peking University Third Hospital
name: Haiyan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601925: Distances From Cricoid Cartilage to the Targets of Stellate Ganglion Block
Official title: Distances From Cricoid Cartilage to the Targets of Stellate Ganglion Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herpes Zoster
CRPS
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stellate ganglion block targets are C6 transverse process or C7 transverse process in anterior paratracheal approach which is most popular method. Cricoid cartilage is known that it is located at C6 level in supine neutral position of the neck. But stellate ganglion block is performed in supine extended position of the neck. So cricoid cartilage will move up to cephalad direction and pain doctors should find C6 or C7 transverse process at lower neck area than cricoid cartilage.


Eligibility criteria: Inclusion Criteria:

* adults above age of 20 reserved for musculoskeletal ultrasonography

Exclusion Criteria:

1. past history of neck surgery
2. the limitation of neck motion due to rheumatoid arthritis, et al.
3. severe neck pain
4. inability to communicate or read or write

Primary outcomes:
measure: the distances from cricoid cartilage to C6, C7 transverse process in supine neutral and extended position of the neck
timeFrame: up to 1 week
Secondary outcomes:
measure: the sexual difference in the distances from cricoid cartilage to C6, C7 transverse process in supine neutral or extended position of the neck
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
Study officials:
affiliation: Yonsei University
name: Jong B Choi
role: STUDY_DIRECTOR
References: