louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00354952: Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
Official title: Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Antibiotic exposure
Resistance selection
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-07-20
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.

Detailed description: Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level. 203 healthy cohorts were treated with azithromycin, clarithromycin, or a placebo in a randomised, double-blind trial. Pharyngeal swabs were collected pre- (day 0) and post-antibiotic administration (days 8, 14, 28, 42, 180) and proportions of macrolide-resistant streptococci (MRS) were determined at each time-point.

Eligibility criteria: Inclusion Criteria:

* healthy adults (≥ 18 years of age)
* non-pregnant
* free of any respiratory tract infection
* not having been administered any antibiotic at least in the past three months

Exclusion Criteria:

* \<18 years of age
* pregnant
* having a respiratory tract infection
* having been administered any antibiotic at least in the past three months

Primary outcomes:
measure: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
Secondary outcomes:
measure: Variations in the carriage of macrolide-resistance genes due to macrolide exposure.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Depatment of Medical Microbiology, Universiteit Antwerpen
Study officials:
affiliation: Universiteit Antwerpen
name: Herman Goossens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H. Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet. 2007 Feb 10;369(9560):482-90. doi: 10.1016/S0140-6736(07)60235-9.
Clinical trial NCT00755352: A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.
Official title: Efficacy of WelChol as an Add-on to Pravastatin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 67
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: Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female \> or = to 18 years of age
* On a stable dose of pravastatin
* LDL-C \> or = to 100 mg/dL and \< or = 250 mg/dL
* Triglycerides \< or = to 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion Criteria:

* BMI \> 40 kg/m2
* History of allergic or toxic reaction to colesevelam HCL
* History of swallowing disorder
* Any serious condition that would interfere with the conduct of the study

Primary outcomes:
measure: The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.
timeFrame: 6 weeks
Secondary outcomes:
measure: The absolute change in LDL-C from baseline to endpoint.
timeFrame: 6 weeks
measure: The absolute change and % change of total cholesterol from baseline to endpoint
timeFrame: 6 Weeks
measure: The absolute change and % change of triglycerides from baseline to endpoint
timeFrame: 6 Weeks
measure: The absolute change and % change of HDL-C from baseline to endpoint
timeFrame: 6 Weeks
measure: The absolute change and % change of c-reactive protein from baseline to endpoint
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Castle Rock
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Bartlett
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT06184152: CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
Official title: Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HCC
Hepatocellular Carcinoma
Keywords: LR3
LR4
HCC Surveillance
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2023-12-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will be conducted at the following locations:

1. UT Southwestern Medical Center
2. Parkland Health and Hospital System
3. University of Michigan

Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.

Detailed description: Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months. Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day, although will be permitted to be completed within 30 days of each other. Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.

Eligibility criteria: Inclusion Criteria:

* Child A or B cirrhosis from any etiology with at least one ILN on 4-phase CT, contrast- enhanced MRI, or contrast enhanced US but without HCC at baseline.
* Adults 18 years old and above

Exclusion Criteria:

* Patients post liver transplantation
* Patients with concurrent or prior HCC (LR-5 or biopsy proven)
* other liver cancer including cholangiocarcinoma
* Patients with any active extra-hepatic malignancy
* Patients with significant comorbidity and limited life expectancy, e.g., stage D congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit
* Patients with contraindication to contrast-enhanced MRI or CEUS, including implanted medical devices that are considered MR unsafe and severe claustrophobia

Primary outcomes:
measure: Early HCC Detection
timeFrame: 5 years
Secondary outcomes:
measure: HCC Detection
timeFrame: 5 years
measure: Early HCC Detection
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT00198952: Effects of Herbal Products on Metabolism and Hunger
Official title: Effects of Herbal Products on Metabolism and Hunger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolism
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Natural Prescriptions
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other blood)and hunger/caloric compensation on ephedra versus placebo


Eligibility criteria: Inclusion Criteria:

age 18-50, non-smoking, not pregnant (serum), Beck \<15, physician permission

Exclusion Criteria:

pregnant, lactating, smoker, use of appetite-affecting medications

Primary outcomes:
measure: metabolic rate
measure: heart rate
measure: blood pressure
measure: TSH
measure: caloric compensation
Secondary outcomes:
measure: weight
measure: body composition
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence J Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567852: Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
Official title: The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-anesthesia Recovery
Orientation
Keywords: orientation
post-anesthesia recovery
electroconvulsive therapy
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.

Detailed description: ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.

Eligibility criteria: Inclusion Criteria:

* All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.

Exclusion Criteria:

* patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3;
* patients with a known allergic reactions to methohexital , ketamine and succinylcholine;
* patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension;
* patients with uncontrolled severe hypertension.

Primary outcomes:
measure: Re-orientation Time
timeFrame: 1 hour
measure: Recovery Time
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Tony Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04114552: Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
Official title: Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Sprains
Keywords: inversion trauma
Ankle sprain
physical examination
therapy
recurrence
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 112
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who consulted at Tourcoing emergency department for an ankle sprain

Brief summary: Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.


Eligibility criteria: Inclusion Criteria:

Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme

Exclusion Criteria:

Patients deprived of liberty Patients with an unbalanced psychiatric disease If consultation delayed 48 hours due to trauma Patients with fracture Patients with Chopart or Lisfranc injury Pregnant women People who do not speak French

Primary outcomes:
measure: Rate of patients who received a five days post injury new clinical assessment
timeFrame: at 6 weeks
Secondary outcomes:
measure: Oral questionnaires
timeFrame: At 6 weeks
measure: Rate of patients receiving physiotherapy
timeFrame: At 6 weeks
measure: Rate of patients with recurrence
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: Ch Tourcoing
Study officials:
affiliation: University Hospital, Lille
name: Hacène MOUSSOUNI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440552: Evaluation of Colorectal Cancer Screening Strategies in China
Official title: Evaluation of Colorectal Cancer Screening Strategies in China：A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 20000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.


Eligibility criteria: Inclusion Criteria:

* 50-74 years old
* Informed consent is available

Exclusion Criteria:

* Previous colorectal cancer
* Previous colorectal resection
* Previous received cancer-related treatment (except non-melanoma skin cancer)
* Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
* Fecal occult blood or fecal DNA was performed within one year
* Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)

Primary outcomes:
measure: Detection rate
timeFrame: up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06046352: Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia
Official title: Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraventricular Tachycardia
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with palpitations clinically suggestive of paroxysmal supraventricular tachycardia but no ECG documentation of tachycardia

Brief summary: BELIEVE-SVT is a European multi-centre, retrospective registry in tertiary hospitals performing electrophysiological study in patients with palpitations considered clinically suggestive of paroxysmal supraventricular tachycardia by a cardiologist and without electrocardiographic documentation of tachycardia or preexcitation. Clinical characteristics, results of electrophysiological study and ablation, complications, and clinical outcomes during follow-up will be analysed.

Detailed description: The "Symptom Burden As Guiding Principle For Invasive Electrophysiological Study In Paroxysmal Supraventricular Tachycardia (Believe-SVT)" study was a multi-centre, retrospective, observational registry carried out in tertiary European hospitals. Inclusion criteria were: symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist; absence of any sort of electrocardiographic tracing during episodes (including wearables and other single lead devices), and having undergone an electrophysiological study aimed at the diagnosis of paroxysmal supraventricular tachycardia.

Eligibility criteria: Inclusion criteria:

* Symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist
* Absence of any sort of ECG tracing during episodes (including wearables and other single lead devices)

Exclusion criteria:

* Documentation of preexcitation
* Prior electrophysiological study aimed at the assessment of ventriculo-atrial conduction or induction of supraventricular tachycardias.

Primary outcomes:
measure: Electrophysiological study findings
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: University Hospital 12 de Octubre
name: Daniel Rodriguez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943852: The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
Official title: A Double-Blind, Randomized, Placebo-Controlled, 5-Period Crossover Study to Evaluate the Effects of a Single Dose of Losartan, a Single Dose of Isosorbide Mononitrate (ISMN), and Single Doses of Losartan + ISMN on Central Blood Pressure Measurements in Mildly Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 13
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.


Eligibility criteria: Inclusion Criteria:

* Patient is in good health with the exception of mild to moderate hypertension
* Patient is willing to comply with the study restrictions
* Patient does not smoke

Exclusion Criteria:

* Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
* Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
* Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®

Primary outcomes:
measure: Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg
timeFrame: Baseline and 10 hours postdose
measure: Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo
timeFrame: Baseline and 10 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kaufman R, Nunes I, Bolognese JA, Miller DL, Salotti D, McCarthy JM, Smith WB, Herman GA, Feig PU. Single-dose effects of isosorbide mononitrate alone or in combination with losartan on central blood pressure. J Am Soc Hypertens. 2010 Nov-Dec;4(6):311-8. doi: 10.1016/j.jash.2010.10.004.