louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01341730: The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
Official title: Evaluation of the Effect of Atorvastatin and Pioglitazone in Carotid Atherosclerosis With the Use of 18Fluoride-Fludeoxyglucose(FDG) Positron Emission Tomography-computed Tomography (PET-CT)Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Atherosclerosis
Pioglitazone
Atorvastatin
PET CT
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Jeil Pharmaceutical Co., Ltd.
First posted: 2011-04-26
Enrollment: 41
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 study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.


Eligibility criteria: Inclusion Criteria:

* The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina)
* The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography
* The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form.

Exclusion Criteria:

* The subjets who have taken statins or thiazolidinedione with 4 weeks
* Marked elevated liver enzyme ( more than 2.5 fold compared to reference range)
* Renal insufficiency patients ( serum creatinine more than 2 mg/dl)
* Congestive heart failure ( NYHA class 2-4)
* Acue myocardial infarction
* Unstable angina with ST segment deviation
* Pregnancy
* The subjects enrolled in another studies

Primary outcomes:
measure: Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
timeFrame: 3 months
Secondary outcomes:
measure: Difference PET CT Parameters in 3 Months Compared to Initial Evaluation
timeFrame: 3 months
measure: Difference of Laboratory Data Compared to Initial Evaluation
timeFrame: 3 months
measure: Clinical Incidents
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiovascular center, Seoul St. Mary's hospital
Study officials:
affiliation: Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
name: Kiyuk Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choo EH, Han EJ, Kim CJ, Kim SH, O JH, Chang K, Seung KB. Effect of Pioglitazone in Combination with Moderate Dose Statin on Atherosclerotic Inflammation: Randomized Controlled Clinical Trial Using Serial FDG-PET/CT. Korean Circ J. 2018 Jul;48(7):591-601. doi: 10.4070/kcj.2017.0029.
Clinical trial NCT01274130: Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Official title: Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The investigators will apply ranitidine and verapamil to the drug interaction study of metformin.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 20 to 50 years at screening
* Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight : Ideal body weight = (height cm - 100) x 0.9
* Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial

Exclusion Criteria:

* Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
* Subjects who have participated in other clinical trial within 1 month prior to the first day of drug administration
* Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03640130: Peripheral Reading
Official title: Factors Limiting Peripheral Reading
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Visual Impairment
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.

Detailed description: Participants will view paragraphs of multiple sentences of text with their central vision blocked computationally with a "simulated scotoma." Participants will be free to move their eyes around the page of text at a comfortable rate. The three outcomes described elsewhere will be evaluated.

In different blocks, text will contain one or more of several dynamic assistive manipulations that are hypothesized to enhance reading: 1) inverting the text at a given position, with instructions for the participant to attend to that location, which simulates a "surrogate fovea" of a patient with central vision loss. 2) horizontally expanding text to alleviate within-word crowding. 3) highlighting the next word with a visible indicator to encourage proper eye movements.

Eligibility criteria: Inclusion Criteria:

* Normal vision
* English language

Exclusion Criteria:

* Less than 20/20 vision in either eye
* Abnormalities which affect vision (amblyopia, keratoconus, etc.)
* Ortho-K lenses

Primary outcomes:
measure: Reading speed
timeFrame: From enrollment to completion of testing (<2 weeks)
measure: Reading accuracy
timeFrame: From enrollment to completion of testing (<2 weeks)
measure: Efficiency of eye movement
timeFrame: From enrollment to completion of testing (<2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
Study officials:
References:
Clinical trial NCT00599430: Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections
Official title: Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Probiotic
Lactobacillus
NCFM
Bifidobacterium
Healthy children
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 326
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.


Eligibility criteria: Inclusion Criteria:

* Children aged 3-5 years of normal nutritional status and health

Exclusion Criteria:

* Contraindications to dairy products (lactose intolerance or cow's milk allergy)
* Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
* Chronic cough from recurring respiratory distress-related diseases
* Hirschsprung's disease
* Cystic fibrosis
* Other metabolic, neurological, or anatomic alteration that predisposes participation
* Intake of probiotics within the last 3 weeks

Primary outcomes:
measure: To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.
timeFrame: Daily for six months
Secondary outcomes:
measure: To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.
timeFrame: Six months
Other outcomes:
Locations:
city: Jinhua City
country: China
facility: Day care center
state: Zhejiang
Study officials:
affiliation: Sprim Advanced Life Sciences
name: Charlie Zhang
role: STUDY_DIRECTOR
affiliation: Sprim Advanced Life Sciences
name: Cheryl Riefer
role: STUDY_CHAIR
References:
citation: Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
Clinical trial NCT03818230: An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.
Official title: An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Depression
Anxiety
Hope
Psychological Distress
Keywords: Clinical trials
Early phase clinical trials
Experimental cancer medicine
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2019-01-28
Enrollment: 64
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: Patients who have been referred to the Experimental Cancer Medicine Team (ECMT) at The Christie NHS Foundation Trust, to be considered for participation in an early phase clinical trial.

Brief summary: This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older
* Able to provide informed consent
* Are being considered for an early phase clinical trial

Exclusion Criteria:

* Patients unable to comprehend English language

Primary outcomes:
measure: Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
timeFrame: Approximately 14 weeks.
Secondary outcomes:
measure: Levels of hope as per the Adult Hope Scale.
timeFrame: Approximately 14 weeks.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
References:
Clinical trial NCT05830630: Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
Official title: The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineural
Methylene Blue
Lower Limb Amputation
Keywords: Perineural
Methylene blue
Lower limb amputation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery

Detailed description: Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.

Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia.

Exclusion Criteria:

* Patients with a history of allergy to local anesthetics.
* Patients with allergy to methylene blue.
* Anticoagulant use or coagulopathy.

Primary outcomes:
measure: Degree of postoperative pain
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Incidence of phantom limb pain
timeFrame: 9 months after surgery
Other outcomes:
measure: Incidence of stump pain
timeFrame: 9 months after surgery
measure: Postoperative opioid consumption
timeFrame: 3 days after surgery
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbiya
Study officials:
References:
Clinical trial NCT00110630: Smoking Treatment of Prisoners
Official title: Smoking Treatment of Prisoners: Project "STOP"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Keywords: nicotine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: GlaxoSmithKline
First posted: 2005-05-11
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy combined with NicoDerm CQ for smoking cessation among female prisoners.

Detailed description: This is a randomized controlled trial utilizing a wait-list control group to examine 10-week group therapy and nicotine replacement compared to wait-list for smoking cessation among female prisoners.

Eligibility criteria: Inclusion Criteria:

* 1) current smoker and (2) seeking group treatment to quit smoking.

Exclusion Criteria:

* (1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.

Primary outcomes:
measure: smoking cessation
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Karen Cropsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826630: A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema
Official title: A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eczema
Hand Eczema
Atopic Dermatitis
Keywords: CLn Body Wash
CLn BodyWash
Lead sponsor: TopMD Skin Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: TopMD Skin Care, Inc.
First posted: 2013-04-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.

Detailed description: Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.

Eligibility criteria: Inclusion Criteria:

* Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
* Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
* Willingness to participate in a research study.
* Diagnosis of chronic hand dermatitis

Exclusion Criteria:

* Inability to provide informed consent
* Allergy to any of the treatments used

Primary outcomes:
measure: Change in Amount of Skin Fauna
timeFrame: one wash
Secondary outcomes:
Other outcomes:
Locations:
city: Gahanna
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT00917930: Evaluation Rehabilitation on Glycometabolic State in Non-Diabetic Coronary Artery Disease (CAD) Patients
Official title: Effect of Cardiac Rehabilitation on Glucometabolic State in Non-Diabetic Patients With Chronic Ischemic Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: exercise training
functional recovery
heart diseases
altered glucose metabolism early after an acute cardiac event
non diabetes CAD patients
glycometabolic state
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2009-06-11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: non diabetes patients with coronary artery disease

Brief summary: The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.


Eligibility criteria: Inclusion Criteria:

* patients admitted to undergo a cycle of in-hospital cardiac rehabilitation
* patients without a previous diagnosis of diabetes mellitus
* patients able to start physical training within three days from admission
* fasting blood glucose at admission \< 126 mg/dl

Exclusion Criteria:

* previous diagnosis of diabetes mellitus
* acute coronary events or acute heart failure in the past three months
* physical disabilities that contraindicate training

Primary outcomes:
measure: to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus
Secondary outcomes:
measure: to evaluate the potential beneficial effect of physical training on the glycometabolic state
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01460030: An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Official title: An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parathyroid Carcinoma
Hypercalcemia
Primary Hyperparathyroidism
Keywords: Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).


Eligibility criteria: Inclusion Criteria:

* Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium \> 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is \> 12.5 mg/dL at the screening test).
* Patients who provided their voluntary written informed consent to participate in the study.

Exclusion Criteria:

* Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment.
* Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma.
* Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
* Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.

Primary outcomes:
measure: Corrected serum calcium
Secondary outcomes:
measure: Serum intact parathyroid hormone
Other outcomes:
Locations:
city: Sendai
country: Japan
Study officials:
References: