louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01658202: Nicotine Patch Bioequivalence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Smokers
Keywords: Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.

4 single 24hour applications separated by 48hour intervals.


Eligibility criteria: Inclusion Criteria:

* Healthy subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: Blood samples will be collected on Days 1, 3, 5 and 7
Secondary outcomes:
measure: Clinical safety (reported adverse events)
timeFrame: up to day 9
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
References:
Clinical trial NCT03444402: A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects
Official title: A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Keywords: CKD-381
Nexium
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 18
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: A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Detailed description: A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy male adult
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can effect drug absorption or surgery.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Primary outcomes:
measure: AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
timeFrame: 0~24h
Secondary outcomes:
measure: Cmax,ss(Maximum concentration of drug in plasma at steady state)
timeFrame: 0~24h
measure: Tmax,ss(Time to maximum plasma concentration at steady state)
timeFrame: 0~24h
measure: t1/2(Terminal elimination half-life)
timeFrame: 0~24h
measure: R(Accumulation ratio)
timeFrame: 0~24h
measure: CLss/F(Apparent Clearance at steady state)
timeFrame: 0~24h
measure: Vss/F(Apparent Volume of distribution at steady state)
timeFrame: 0~24h
measure: Cmax(Maximum concentration of drug in plasma)
timeFrame: 0~24h
measure: AUClast(Area under the plasma drug concentration-time curve from 0 to last)
timeFrame: 0~24h
measure: Tmax(Time to maximum plasma concentration)
timeFrame: 0~24h
measure: t1/2(Terminal elimination half-life)
timeFrame: 0~24h
measure: CL/F(Apparent clearance)
timeFrame: 0~24h
measure: Vd/F(Apparent volume of distribution)
timeFrame: 0~24h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital
name: Kyung Sang Yu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06808802: To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants
Official title: A Phase 1, Open-label, Single-arm Study to Investigate the Effect of Retatrutide on Metoprolol Pharmacokinetics in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study J1I-MC-GZQE is to measure the effect of retatrutide on the pharmacokinetics (PK) of metoprolol in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and vital signs
* Have a body mass index (BMI) within the range 22.0 to 35.0 kilogram per square meter (kg/m2) (inclusive) at screening

Exclusion Criteria:

* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimole/mole (mmol/mol)
* Have a mean supine screening pulse rate of less than 45 or greater than 100 beats per minute (bpm) from 2 assessments. If a repeat measurement (mean of 2 assessments) shows values within the range of 45 to 100 bpm, the participant may be included in the trial
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
* Had any of the following cardiovascular conditions prior to screening: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalization due to congestive heart failure

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol
timeFrame: Day 1 to Day 3
measure: Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide
timeFrame: Day 9 to Day 11
measure: PK: Maximum Concentration (Cmax) of Metoprolol
timeFrame: Day 1 to Day 3
measure: PK: Cmax of Metoprolol with Retatrutide
timeFrame: Day 9 to Day 11
Secondary outcomes:
measure: Number of Participants with an Incidence of Treatment Emergent Adverse Events TEAEs (TEAEs)
timeFrame: Baseline to Day 44
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01991002: 14/21 Diet-walking in the Park
Official title: Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight: 25 <BMI <30
Keywords: 14/21 diet
BMI
biochemical blood markers
quality of life
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance.

Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance.

Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.

Detailed description: An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period.

Participants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.

The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.

Eligibility criteria: Inclusion Criteria:

Hebrew speaking 25\<BMI\<30 18 years old or older signed an informed consent

Exclusion Criteria:

Subjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans

-

Primary outcomes:
measure: Weight reduction
timeFrame: 2 years
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: 2 years
Other outcomes:
measure: Biochemical markers
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: Quality of life.
timeFrame: 2 years
Locations:
city: Tel Aviv
country: Israel
facility: Assuta medical centers
Study officials:
affiliation: Assuta Hospital Systems
name: Joshua Shemer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056702: Impact of Triple Combination CFTR Therapy on Sinus Disease.
Official title: Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: Chronic Sinusitis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2019-08-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with cystic fibrosis and chronic sinusitis.

Brief summary: The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.

Detailed description: To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus CT scan and complete questionnaires related to signs and symptoms of sinus disease.

Eligibility criteria: Inclusion Criteria:

1. Subjects from 18 to 89 years old.
2. Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record).
3. Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride \> 90 mmol/L.

Exclusion Criteria:

1. Subjects under the age of 18 or over the age of 89.
2. Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons.
3. Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period.
4. Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.

Primary outcomes:
measure: Change in Sinus CT opacification.
timeFrame: Change in Sinus CT opacification between the initial and 6 month visits.
Secondary outcomes:
measure: Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score.
timeFrame: Change in SNOT-22 score between the initial and 6 month visits.
measure: Change in Questionnaire for Olfactory Disorders (QOD) score
timeFrame: Change in QOD score between the initial and 6 month visits.
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Jennifer TaylorCousar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03735602: Neural Mechanisms Underlying Astigmatism
Official title: The Research of the Neural Mechanisms Underlying Astigmatism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Astigmatism
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

Detailed description: The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. However, the neural mechanisms underlying the astigmatism remains unknown. The current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. This main aim is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

Patients with astigmatism or amblyopia were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination.

Eligibility criteria: Inclusion Criteria:

* high astigmatism

Exclusion Criteria:

* other types of disease (especially optical diseases) that may affect study

Primary outcomes:
measure: The change of the contrast sensitivity function tested by quick CSF
timeFrame: eight months
measure: The change of contrast threshold tested by sweep visually evoked potential (VEP)
timeFrame: eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Jin Yuan, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03361202: Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium
Official title: Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Société Française de Cardiologie
First posted: 2017-12-04
Enrollment: 50
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: two groups of patients:

* control
* atrial fibrillation

Brief summary: The aim of the study is to compare levels of differnts types of microparticles circulating before and after percutaneous occluding of the left atrium by patients with atrial fibrillation and patients control.

Hypothesis is that prothesis implantation will decrease levels of microparticles circulating in blood circulation because of occluding of the left atrium .


Eligibility criteria: Inclusion Criteria:

atrial fibrillation group:

* high embolic risk (CHADS-VASC2 score ≥4)
* formal and final contraindication to anticoagulant therapy
* no heart thrombus on ETO and TDM before percuraneous occluding

control group:

* suspicion of stable coronary artery disease, coronary angiography scheduled and double platelet aggregation (clopidogrel and aspirine)

Exclusion Criteria: for both groups

* congestive heart failure, severe aortic stenosis, EP or TVP early.

Primary outcomes:
measure: levels of microparticles expressing phosphatidylserine in atrial fibrillation group
timeFrame: 45 days after Percutaneous Occluding of the Left Atrium.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Nicolas AMABILE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141902: The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors
Official title: The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Syndrome
Emotional Stress
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aim to explore the impact of Jing Si Herbal Tea on pain and emotional stress in peripheral blood stem cell donors.


Eligibility criteria: Inclusion Criteria:

* health Men or women aged 20 to 55 years old
* willing to take Jing Si Herbal Drink

Exclusion Criteria:

* no willing to take Jing Si Herbal Drink;
* Previously already take Jing Si Herbal Drink daily

Primary outcomes:
measure: Changes in pain assessed by questionnaires
timeFrame: 5 day
Secondary outcomes:
measure: Changes in anxiety assessed by questionnaires
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00454402: ALF-STONE: Alfuzosin in Uretheric Stones
Official title: Alfuzosin in Uretheric Stones
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.

This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).


Eligibility criteria: Inclusion criteria:

* Patients with imagiologic evidence of uretheric stones

Exclusion criteria:

* Women pregnant or breast feeding
* Patients with renal impairment (creatinine \> 2mg/dl)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Safety: General clinical safety by collection of spontaneously reported adverse events
timeFrame: at each visit
measure: Efficacy: Percentage of patients without imagiologic evidence of any stone
timeFrame: 72h to 96 hours after ESWL
Secondary outcomes:
measure: Percentage of patients without imagiologic evidence of any stone
timeFrame: 24 hours after ESWL
measure: Percentage of patients with clinical evidence of stones clearance
timeFrame: 72h to 96 hours after ESWL
measure: Time for stone clearance (clinical evaluation)
measure: Numeric Rating Scale scores
timeFrame: at 24h, (48h, if applicable), 72-96h and 7 days
measure: Need for rescue analgesic medication.
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Carlos Santos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00579202: Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
Official title: The Gambro Polyflux HD-C4 Small Ease of Use Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Keywords: Dialyzer
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2007-12-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients

Brief summary: The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis

Detailed description: Market evaluation protocol.

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.

Eligibility criteria: Inclusion Criteria:

* n/a routine dialysis patients

Exclusion Criteria:

* n/a routine dialysis patients

Primary outcomes:
measure: For each dialyzer, the perceived ease of priming.
timeFrame: During priming of each dialyzer
Secondary outcomes:
measure: Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.
timeFrame: At the completion of each treatment
Other outcomes:
Locations:
city: Lanham
country: United States
facility: Advanced Dialysis Center
state: Maryland
Study officials:
affiliation: Advanced Dialysis Center
name: Rana Irmindra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: