louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01688193: Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
Official title: Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 68
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy korean male

Brief summary: The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male


Eligibility criteria: Inclusion Criteria:

* BMI: 18.0 - 27.0 kg/m2
* Willingness to sign the written Informed Consent Form

Exclusion Criteria:

* Evidence of clinically relevant pathology
* History of relevant drug and food allergies
* Positive screen on drugs of abuse
* Participation in a drug study within 60 days prior to drug administration.

Primary outcomes:
measure: AUClast, Cmax of Naproxen and Esomeprazole
timeFrame: Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
Secondary outcomes:
measure: Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole
timeFrame: Naproxen : 0h, 30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h Esomeprazole: 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul University Hospital
Study officials:
References:
citation: Wang-Smith L, Fort J, Zhang Y, Sostek M. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol. 2012 May;52(5):670-80. doi: 10.1177/0091270011405500. Epub 2011 May 31.
Clinical trial NCT03859193: Education Nutritional Video for Gestational Diabetics
Official title: Education Nutritional Video for Gestational Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to find out if watching an educational video about nutrition helps participants learn about how different foods affect their blood sugar and how Gestational Diabetes affects pregnancy.

Detailed description: * Patients diagnosed with gestational diabetes receive standard nutritional counseling at their first high risk clinic visit. All patients agreeing to participate in the study will at this visit fill out a knowledge questionnaire prior to receiving counseling.
* Patients will be randomized into standard counseling or standard counseling plus educational video using block randomization that has been integrated into the Redcap Survey. Once the Initial survey is completed the RedCap program will inform the patient whether they are randomized to Video or NO Video.
* Patients randomized to Video will watch the video will watch the video on a clinic designated computer. Patients randomized to no Video will not watch a video.
* At the next High risk clinic visit one to two weeks later all patients will fill out the same fill out the same questionnaire in addition to the The Problem Areas In Diabetes (PAID) questionaire.
* English-speaking patients will view the English version of the video, and Spanish-speaking patients will view the Spanish version of the video in either English or the dubbed Spanish version.
* A Spanish version of the patient hand-out will be provided in an amendment, prior to their use with Spanish- speaking patients.

Eligibility criteria: Inclusion Criteria:

* Any diagnosis of Diabetes in Pregnancy
* Received at least one session of nutritional counseling from the registered dieticians

Exclusion Criteria:

* Age \< 18
* Patients without diagnosis of diabetes

Primary outcomes:
measure: Change in nutritional knowledge
timeFrame: Baseline to 1 week
Secondary outcomes:
measure: Problem Areas In Diabetes (PAID) questionnaire Score
timeFrame: 1 week
measure: Patient Satisfaction with Care
timeFrame: 1 week
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Deborah Koehn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021693: Learning Outcomes With Point-of-Care Ultrasound
Official title: Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Keywords: Medical Education
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intern physicians were randomized 1:1 to receive personal access to a handheld ultrasound device vs. no device. The groups did not cross over in which intervention they received.
Primary purpose: OTHER

Brief summary: Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether handheld ultrasound devices, along with a year-long lecture series, improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning vs. no personal access. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and lecture attendance.


Eligibility criteria: Inclusion Criteria:

* Internal Medicine Intern Physicians at Stanford University

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean Percent Correct On Image Assessments at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Mean Reported Device Usage Rates at 1 year
timeFrame: 1 year
measure: Mean Lecture Attendance at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Clinical Assistant Professor
name: Andre D Kumar, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Kugler J, Jensen T. Evaluation of Trainee Competency with Point-of-Care Ultrasonography (POCUS): a Conceptual Framework and Review of Existing Assessments. J Gen Intern Med. 2019 Jun;34(6):1025-1031. doi: 10.1007/s11606-019-04945-4.
citation: Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
Clinical trial NCT02124993: The Effect of Sleeve Gastrectomy on Food Preference
Official title: The Effect of Sleeve Gastrectomy on Food Preference
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Obesity
Keywords: Gastrectomy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dr. Drake Bellanger sleeve gastrectomy surgery

Brief summary: This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.

Detailed description: Participants that will undergo the sleeve gastrectomy surgery by Dr. Drake Bellanger's, will be asked to participant in a questionnaire survey. Once given the consent to participate, a food preference questionnaire (FPQ) will be administered at a pre-operative visit and then a six-week follow up visit at Dr. Drake Bellanger's office.

Eligibility criteria: Inclusion Criteria:

* Male or Female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.

Exclusion Criteria:

* Women who are pregnant or nursing.

Primary outcomes:
measure: Participants food preferences before sleeve gastrectomy surgery and after surgery.
timeFrame: Change from Baseline in preferences after follow-up six weeks
Secondary outcomes:
measure: Participants weight change before sleeve gastrectomy surgery and after surgery focusing on specific macronutrient.
timeFrame: Change from Baseline in weight after follow-up six weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Dr. Drake Bellanger
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008693: Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
Official title: Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Hypertension
Dyslipidemias
Abdominal Obesity
Keywords: Aging
Aged Garlic
Functional Food
Vascular Function
Muscle oxygenation
Exercise performance
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The number of elderly individuals affected by cardiovascular diseases has been increasing in our country. Garlic (Allium sativum) has been associated with decrease of reactive species of oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and especially cardiovascular diseases. The present study evaluated the effects of a garlic supplementation on vascular function and blood pressure in the elderly at cardiometabolic risk. Twenty-eight elderly individuals were submitted to an ingestion of four capsules of an aged garlic extract (KYOLIC® Aged Garlic Extract™). Muscle oxygenation and function were measured 180 min after interventions. Urinary thiosulfate, blood nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline and 180 min after interventions.


Eligibility criteria: Inclusion Criteria:

* Cardiometabolic risks
* Cardiovascular diseases

Exclusion Criteria:

* Cancer;
* HIV positive;
* Alcohol or drug abuse within the past 6 months previous the visit 1;
* Garlic allergy;

Primary outcomes:
measure: Near infrared spectroscopy 1
timeFrame: 180 minutes after nutritional intervention
measure: High performance liquid chromatography 1
timeFrame: Baseline and 180 minutes after nutritional intervention
measure: High performance liquid chromatography 2
timeFrame: Baseline and 180 minutes after nutritional intervention
measure: Near infrared spectroscopy 2
timeFrame: 180 minutes after nutritional intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Macaé
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Campus Macaé
state: Rio De Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro - Campus Macaé
name: Thiago Alvares
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Rio de Janeiro - Campus Macaé
name: Thiago Alvares
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leitao R, de Oliveira GV, Rezende C, Volino-Souza M, Mesquita J, de Carvalho LL, Alvares TS. Improved microvascular reactivity after aged garlic extract intake is not mediated by hydrogen sulfide in older adults at risk for cardiovascular disease: a randomized clinical trial. Eur J Nutr. 2022 Oct;61(7):3357-3366. doi: 10.1007/s00394-022-02895-y. Epub 2022 May 4.
Clinical trial NCT05446493: Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Official title: Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Erectile Dysfunction With Diabetes Mellitus
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with ED.

Exclusion Criteria:

* Patients with history of pelvic trauma.
* Patients with major pelvic surgical intervention.
* Patients with hypogonadism and hyperprolactinemia.
* Patients with chronic liver disease.
* Patients with cardio vascular system diseases.
* History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.
* Smokers patients.
* Patients with non-vasculogenic Erectile dysfunction.

Primary outcomes:
measure: Serum YKL-40 and platelets indices in erectile dysfunction
timeFrame: 3 months
Secondary outcomes:
measure: Effect of tadalafil on Erectile dysfucntion patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan university
Study officials:
References:
Clinical trial NCT02178293: Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride
Official title: MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) "Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharyngitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-30
Enrollment: 214
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: A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis
* Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)
* At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3
* Release of written informed consent by the patient

Exclusion Criteria:

* Patients suffering from a microbial infection requiring specific antimicrobial treatment
* Patients who have taken the trial drugs during the week before enrolment
* Patients who have taken corticosteroids or antibiotics during the week before enrolment
* Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general
* Patients who are unable to properly fill in the diary every day as provided for by the protocol
* Ascertained or presumed pregnant or lactating women
* Inclusion in any other clinical trial during the study

Primary outcomes:
measure: Duration of analgesic effects in hours
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Average number of days required to obtain remission of pain
timeFrame: Up to day 8
measure: Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale
timeFrame: Up to day 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00550693: Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Official title: A Crossover Intervention Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter Related Bloodstream Infection
Keywords: bloodstream infections
hemodialysis catheter
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There are currently no published data on the efficacy of the chlorhexidine-impregnated foam dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.

The researchers perfomed a cross-over intervention trial on patients who were dialyzed through central venous catheters at two outpatient dialysis centers were enrolled. The use of a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol during the intervention period. A nested cohort study of all patients who received the foam dressing was also conducted to determine independent risk factors for development of BSI.

The primary outcomes were the catheter-related bloodstream infection rates in the intervention and control groups. Secondary outcomes include the clinical sepsis rates between the two groups and risk factors for development of bloodstream infection despite the use of the foam dressing.


Eligibility criteria: Inclusion Criteria:

* All patients who were dialyzed through a central venous catheter during the time period

Exclusion Criteria:

* Patients who were allergic to chlorhexidine

Primary outcomes:
measure: Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions
timeFrame: over a six-month period
Secondary outcomes:
measure: clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention
timeFrame: over a 6 month period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Dialysis Center
state: Missouri
city: Saint Louis
country: United States
facility: Chromalloy American Kidney Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bernard C Camins, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839993: tDCS Effects on Associative Learning in Older Adults of Retirement Age
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: tDCS effects
associative learning
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.


Eligibility criteria: Inclusion Criteria:

* Age: old-retired (≥66 years).
* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)

Primary outcomes:
measure: Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS.
timeFrame: Performance is assessed within 1 day immediately after training period (several learning blocks) compared to sham
Secondary outcomes:
measure: Functional connectivity predictors
timeFrame: assessed during baseline testing
measure: Structural predictors
timeFrame: assessed during baseline testing
measure: Genotyping of learning related polymorphisms
timeFrame: assessed during baseline screening
measure: Other cognitive outcomes: Attention performance
timeFrame: Performance is assessed within 1 day before and after tDCS + training compared to sham
measure: Other cognitive outcomes: working memory
timeFrame: Performance is assessed within 1 day before and after tDCS + training compared to sham
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.
citation: Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.
citation: Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.