louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01735045: LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Official title: LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Lead sponsor: Szabocsik and Associates, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.


Eligibility criteria: Inclusion Criteria:

* Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
* Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
* Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
* Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:

  1. No evidence of lid infection.
  2. No structural lid abnormality.
  3. No conjunctival abnormality or infection.
  4. A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
  5. No iritis.
  6. No other active ocular disease that would contraindicate use of the investigational lens.
  7. No GPC (giant papillary conjunctivitis, tarsal abnormality) Grade 2 or greater
* Use no ocular medication.
* Have no known sensitivity to solutions currently used for contact lens care.
* Have binocular correction with contact lenses.

Exclusion Criteria

* Astigmatism \>1.50D
* No monocular or monovision fits may be included.
* Pregnant and lactating women are excluded from the study
* Minors (under age 18) are excluded from the study

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months
Secondary outcomes:
measure: Slit Lamp Findings
timeFrame: 3 months
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Glenda Secor, OD
state: California
city: Honolulu
country: United States
facility: Randall Sakamoto
state: Hawaii
city: Oak Lawn
country: United States
facility: Robert Davis, OD
state: Illinois
city: Concord
country: United States
facility: Douglas P. Benoit, OD, FAAO
state: New Hampshire
city: Londonderry
country: United States
facility: Stephen P. Byrnes, OD, FAAO
state: New Hampshire
Study officials:
name: John M Szabocsik, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00627445: Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 441
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: This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
* HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
* FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
* BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Exclusion Criteria:

* Metformin contraindications according to local practice
* Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: week 0, week 16
Secondary outcomes:
measure: The Percentage of Subjects Achieving HbA1c Treatment Targets
timeFrame: week 16
measure: Change and Daily Average in 8-point Plasma Glucose
timeFrame: week 0, week 16
measure: Change and Daily Average in Prandial Plasma Glucose Increment
timeFrame: week 0, week 16
measure: The Total Increase in Total Daily Insulin Dose Per Body Weight
timeFrame: week 0, week 16
measure: Change in Body Weight
timeFrame: week 0, week 16
measure: Number of Hypoglycaemic Episodes
timeFrame: weeks 0-16
measure: Number of Nocturnal Hypoglycaemic Episodes
timeFrame: weeks 0-16
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06404645: A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma
Official title: A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Hemorrhages
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergo cranial CT that reveal a unilateral intracranial hemorrhage. Once meeting the inclusion and exclusion criteria, patients sign an informed consent and then undergo NIRS test.

Brief summary: This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.


Eligibility criteria: Inclusion Criteria:

1. Age above 18 years old
2. Unilateral subcranial hemorrhage confirmed by cranial CT

Exclusion Criteria:

1. Bilateral subcranial hemorrhage
2. Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
3. Obvious skull fracture in the location of hemorrhage on cranial CT

Primary outcomes:
measure: NIRS data1
timeFrame: 3 months
Secondary outcomes:
measure: NIRS data2
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Junfeng Feng
role: STUDY_CHAIR
References:
Clinical trial NCT03730545: Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer
Official title: Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Enteral Immunonutrition
Keywords: gastric cancer
enteral nutrition
enteral immunonutrition
immune function
inflammation response
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).

The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 80 years
* with histologically diagnosed cancer of stomach
* candidates for elective subtotal or total gastrectomy

Exclusion Criteria:

* pregnant or lactating woman,
* diagnoses of mental diseases
* resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
* known allergies to nutrition formula or component
* drug intolerance
* known immunodeficiency or autoimmune diseases

Primary outcomes:
measure: Change from baseline serum level of immune cytokines to postoperative day 5
timeFrame: baseline and postoperative day 5
measure: Change from baseline serum level of immune markers to postoperative day 5
timeFrame: baseline, postoperative day 5(POD 5)
measure: Change from baseline serum concentration of immune markers to postoperative day 5
timeFrame: baseline, postoperative day 5(POD 5)
Secondary outcomes:
measure: changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers
timeFrame: baseline, postoperative day 1, 3, and 5
measure: Change among baseline, postoperative day 3 and 5 serum nutritional markers
timeFrame: baseline,postoperative day 3 and 5
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02994745: A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Hyperlipidemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

Detailed description: This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

Eligibility criteria: Inclusion Criteria:

* A Healthy male aged 19-50 years
* Body weight is over 55kg and BMI 18 \~ 27(kg/m2).
* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
* A subject who is eligible according to investigator's assessment

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* History of gastrointestinal disease and resection
* Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
* Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
* A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
* Positive results for serum examination(HIV, B and C viral test, Syphilis).
* Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
* Participation in any other study within 3months.
* History of whole blood donation within 2months and Apheresis 2 weeks.

Primary outcomes:
measure: Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
timeFrame: 0~48 hours after medication
measure: AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin
timeFrame: 0~48 hours after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01716845: SynapDx Autism Gene Expression Analysis Study
Official title: SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Keywords: autism
autism spectrum disorders
RNA
gene expression
developmental delay
Lead sponsor: SynapDx
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children 18 months to \< 5 years referred to a developmental evaluation centers for evaluation of a possible developmental disorder.

Brief summary: This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD.

The sequential co-primary objectives of this study are:

* To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD).
* To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.


Eligibility criteria: Inclusion Criteria:

1. Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
2. Age \>= 18 months and \< 5 years.
3. Parent/legal guardian has been informed about the study and has signed an informed consent form.

Exclusion Criteria:

1. Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
2. Unable or unwilling to complete study procedures

Primary outcomes:
measure: RNA gene expression in peripheral blood
timeFrame: within 30 days of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT01779245: Effect of High-calcium Intake on Substrate Metabolism During Exercise
Official title: The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may be due to a shift in substrate metabolism where there is an increase in the rate of fat oxidation. However, whether high-calcium intake can influence substrate metabolism during exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of high-calcium intake on substrate metabolism during exercise.


Eligibility criteria: Inclusion Criteria:

* Physically active (moderate-vigorous exercise \>3 time per week)
* Male
* 18-40 yrs of age

Exclusion Criteria:

* Smoker
* Known Food Allergies
* Metabolic disorders

Primary outcomes:
measure: Substrate metabolism
timeFrame: 60 s samples every 3 min for 15 min
Secondary outcomes:
measure: Plasma non-esterified fatty acid concentrations
timeFrame: Every 3 min for 15 min
measure: Plasma glycerol concentrations
timeFrame: Every 3 min for 15 min
Other outcomes:
measure: Serum parathyroid hormone concentration
timeFrame: Baseline (Pre-post 2 week supplementation)
measure: Plasma glucose-dependent insulinotropic peptide concentration
timeFrame: Baseline (Pre-post 2 week supplementation)
measure: Plasma glucagon-like peptide-1 concentration
timeFrame: Baseline (Pre-post 2 week supplementation)
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Emma J Stevenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03057197: The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections
Official title: The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbosacral Radicular Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 130
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: OTHER

Brief summary: Caudal epidural injections have been commonly performed in patients with low back pain and radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the sacral canal, present a potential risk of penetration of the epidural venous plexus or dura. The investigators hypothesized that a new caudal injection technique, which the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might represent a safe alternative, with a lower incidence of intravascular injections and patient's discomfort during the procedure than the conventional technique. The study is designed to investigate the influence of the depth of the inserted needle on successful epidurogram and clinical outcome in caudal epidural injections under the ultrasound and digital subtraction angiography.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-80 years of age) who were scheduled to receive caudal epidural injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

* pregnancy
* coagulopathy
* systemic infection
* any active infection at the injection site
* history of allergy to contrast media, local anesthetics, corticosteroid
* patients unable to communicate or patients with cognitive dysfunction

Primary outcomes:
measure: the incidence of intravascular injection
timeFrame: 5 seconds after injection of contrast media via block needle.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
Study officials:
References:
Clinical trial NCT06199297: Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma
Official title: Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective real-world study enrolled patients treated in three medical centers in China, including Sun Yat-sen University Cancer Center, Affiliated Cancer Hospital \& Institute of Guangzhou Medical University, and Sun Yat-Sen Memorial Hospital. These patients, diagnosed with treatment-naive uHCC, underwent simultaneous combination TACE-HAIC and A+B or S+B.

Brief summary: Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.


Eligibility criteria: Inclusion Criteria:

* (a) a confirmed diagnosis of uHCC;
* (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
* (c) Child-Pugh Grade A or B.

Exclusion Criteria:

* (a) previous exposure to other anti-cancer treatments;
* (b) diagnosis of any other primary malignancy;
* (c) significant esophageal varices or observable red wale marks;
* (d) a history of severe cardiac, pulmonary, or renal comorbidities;
* (e) incomplete follow-up records.

Primary outcomes:
measure: objective response rate，ORR
timeFrame: 24 months
measure: progression free survival，PFS
timeFrame: 24 months
Secondary outcomes:
measure: treatment-related adverse events, TRAEs
timeFrame: 24 months
measure: overall survival, OS
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Wei He
state: Guangdong
Study officials:
References: