louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00907101: Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Official title: Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: P Acnes Colonization
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease
* Subjects who:

  * show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
  * have Baseline P acnes count of \> 10,000 per cm2 CFU of the facial skin (forehead)
  * have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline

Exclusion Criteria:

* Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
* Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
* Subjects who have used other medications which may influence skin surface P acnes levels
* Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study

Primary outcomes:
measure: Change From Baseline in Quantitative Bacteriology Measurements at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Worst Post Baseline Tolerability Assessment - Erythema
timeFrame: Week 4
measure: Worst Post Baseline Tolerability Assessment - Dryness
timeFrame: Week 4
measure: Worst Post Baseline Tolerability Assessment - Scaling
timeFrame: Week 4
measure: Worst Post Baseline Tolerability Assessment - Stinging/Burning
timeFrame: Week 4
Other outcomes:
Locations:
city: Broomall
country: United States
facility: Skin Study Center
state: Pennsylvania
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
citation: Leyden JJ, Preston N, Osborn C, Gottschalk RW. In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes. J Clin Aesthet Dermatol. 2011 May;4(5):22-6.
Clinical trial NCT01176201: 14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
Official title: An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: SLV337
Diabetes
Relative bioavailability
ADME
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

Detailed description: The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Eligibility criteria: Inclusion Criteria

* BMI 18 - 28 kg/m2
* SBP 90-140
* DBP 50-90

Exclusion Criteria

* Seizures,
* Orthostatic hypotension

Primary outcomes:
measure: AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)
timeFrame: Part 1: 5 days Part 2: 8 days
measure: AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)
timeFrame: Part 2: 8 days
measure: Excretion balance of total 14C-radioactivity (Part 2)
timeFrame: Part 2: 8 days
measure: Total 14C-radioactivity (Part 2)
timeFrame: Part 2: 8 days
measure: Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)
timeFrame: Part 2: 8 days
Secondary outcomes:
measure: Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)
timeFrame: Part 1: 19 days Part 2: 15 days
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: Site Reference ID/Investigator# 61345
Study officials:
affiliation: Abbott Healthcare Products BV
name: Anita Vanderlaan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03365401: Efficiency of Surgical Treatment for Lumbar Spinal Stenosis
Official title: Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: surgery
decompression
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.

Detailed description: This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.

Eligibility criteria: Inclusion Criteria:

* Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.
* Persistent pain without progressive neurologic dysfunction
* Duration of symptoms and signs for more than 6 months
* Severity of the disease justifying either surgical or nonoperative treatment

Exclusion Criteria:

* severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment
* spinal stenosis not caused by degeneration
* lumbar herniated disc diagnosed during the last 12 months
* neurologic disease causing impaired function of the lower limbs

Primary outcomes:
measure: change of symptoms
timeFrame: 6, 12, and 24 months
Secondary outcomes:
measure: change of pain relief
timeFrame: 6, 12, and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: pekingUPH department of spinal surgery
name: haiying liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT06001801: The Inspiring Action to Prevent Diabetes Intervention
Official title: Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PreDiabetes
Keywords: Diabetes Prevention Program
Behaviors
Weight loss
Healthy lifestyle changes
Peer Partner
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2023-08-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes.

This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers.

Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.


Eligibility criteria: Inclusion Criteria:

* English or Spanish-speaking
* Body Mass Index (BMI) \> 24.9 kilograms/meters squared (kg/m2)
* The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4%

Exclusion Criteria:

* Diagnosed with schizophrenia
* Active alcohol or other drug abuse
* Are pregnant or planning pregnancy in next 6 months
* Will not be in local area in six months
* Will not be able to attend sessions, in-person or remotely, for three more weeks

Primary outcomes:
measure: Number of group sessions attended by participants
timeFrame: 6 months
Secondary outcomes:
measure: Change in weight
timeFrame: baseline, 6 months
measure: Change in hemoglobin A1c
timeFrame: baseline, 6 months
measure: Change in waist circumference
timeFrame: baseline, 6 months
measure: Change in reported diet quality
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Community Health and Social Services Center, Incorporated
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mary Ellen M Heisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00093301: Levosimendan Versus Dobutamine in Shock Patients
Official title: Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cardiogenic Shock
Septic Shock
Keywords: Shock
Levosimendan
Inotropes
Dobutamine
Heart failure
Sepsis
Lead sponsor: Wentworth Area Health Services
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2004-10-07
Enrollment: 40
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: The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).


Eligibility criteria: Inclusion Criteria:

* Reduced left ventricular systolic function
* Hypotension
* Anuria or oligouria

Exclusion Criteria:

* Less than 18 years old
* Pregnant
* Uncorrected valvular stenosis
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Third degree AV block

Primary outcomes:
measure: Resolution of shock state
Secondary outcomes:
measure: Change in cardiac functions
Other outcomes:
Locations:
city: Penrith
country: Australia
facility: Intensive Care Unit, Nepean Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT06655701: Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis
Official title: Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women

Brief summary: The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.

Detailed description: One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with DXA measurements performed within the last 6 months.
* Based on DXA measurements:

Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).

Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.

* Aged 50-75 years

Exclusion Criteria:

* Refusal to participate in the study.
* History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
* Presence of psychiatric disorders.
* Cognitive impairments.
* Use of medications that could affect the study results.

Primary outcomes:
measure: Presence of Stress Urinary Incontinence:
timeFrame: 0 day
measure: Incontinence Quality of Life Scale (I-QOL):
timeFrame: 0 day
measure: Skeletal Muscle Mass:
timeFrame: 0 day
measure: Handgrip Strength
timeFrame: 0 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References:
Clinical trial NCT04350801: Home-based Cognitive Monitoring in MCI
Official title: Usefulness of a Home-based Cognitive Monitoring in Non-demented Patients With High-risk of Dementia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
blood amyloid beta
home-based cognitive monitoring
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinically diagnosed mild cognitive impairment according to Petersen's criteria

Brief summary: This study is an observational study to confirm usefulness of a home-based cognitive monitoring in non-demented patients with high-risk of dementia

Detailed description: We prospectively enroll subjects who were diagnosed as mild cognitive impairment based on neuropsychological tests battery, brain MRI, and routine blood labs including thyroid function tests, vitamine B12 \& folate levels, and syphilis screening to rule out other secondary causes of dementia. We undergo peripheral blood-based amyloid beta levels and regular home-based cognitive monitoring (every 3 months) to investigate whether amyloid-positive MCIs progress rapidly using home-based cognitive monitoring during 6 months.

Eligibility criteria: Inclusion Criteria:

* persistent cognitive complaints
* aged 50 years old or older
* below -1.0 standard deviation in any domain of detailed neuropsychological tests battery named SNSB (Seoul neuropsychological screening battery)
* no ADL (activities of daily living) limitation
* subjects who agreed to participate

Exclusion Criteria:

* dementia patients
* other structural brain disorders such as hydrocephalus, hemorrhage, or tumors
* other neurological disease such as Huntington's disease, Parkinson's disease, or epilepsy

Primary outcomes:
measure: home-based cognitive monitoring score
timeFrame: 3 months (at baseline, 3 months from baseline, 6 months from baseline)
Secondary outcomes:
measure: Hippocampal atrophy grade
timeFrame: at baseline
measure: Number of lacunes
timeFrame: at baseline
measure: Number of microbleeds
timeFrame: at baseline
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's hospital
Study officials:
affiliation: Uijeongbu St. Mary's Hospital
name: YunJeong Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941001: Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)
Official title: Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS) in Primary Care Using a Digital Consultation Tool During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Asthma Attack
Asthma Persistent
Covid19
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: King's College London
First posted: 2021-06-28
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A digital tool, called ReferID has been developed to facilitate the review of asthma patients. It aims to assist in the identification of patients with uncontrolled and/or severe asthma and to ensure a timely referral to secondary care where appropriate. To validate the tool, patients will be randomised to have a review with a healthcare professional using tool to facilitate the review or to continue receiving usual care. Outcome measures including exacerbation frequency and level of asthma control will be assessed at 12 months.


Eligibility criteria: Inclusion Criteria:

* All asthma patients with 1 of more exacerbations in the last 12 months or receiving high dose inhaled corticosteroids.
* Patients able and willing to provide informed consent.
* Patients aged 18 and over.

Exclusion Criteria:

* Patients who lack capacity.
* Patients who do not have a diagnosis of asthma
* Patients who are unable to provide informed consent
* Patients under the age of 18
* Patients already under a severe asthma centre

Primary outcomes:
measure: Rate of exacerbation frequency
timeFrame: 24 months
Secondary outcomes:
measure: Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6.
timeFrame: 12 months
measure: Salbutamol use (measured by the number of inhalers issued)
timeFrame: 24 months
measure: Emergency care utilisation
timeFrame: 24 months
measure: Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ)
timeFrame: 12 months
measure: Adherence to inhaled corticosteroids
timeFrame: 24 months
measure: Inhaler technique assessed.
timeFrame: 12 months
measure: Number of patients referred to secondary care who are taking part in the study.
timeFrame: 12 months
measure: Number of patients initiated on biologic therapy
timeFrame: 12 months
measure: Number of patients who are found to have an incorrect diagnosis.
timeFrame: 12 months
Other outcomes:
measure: Review and feedback of the ReferID Tool
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05835401: Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
Official title: Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Steroid Abuse
Cardiovascular Abnormalities
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through a randomized, crossover, double-blind, placebo-controlled clinical trial, 20 bodybuilders will participate a acute-day trial with two intervention protocols: 1) placebo and 2) nitrate; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval.


Eligibility criteria: Inclusion Criteria:

* Anabolic steroid use in the past or actually;
* Participation at least one bodybuilding competition;

Exclusion Criteria:

* Previous history of acute myocardial infarction and/or stroke;
* Allergy or intolerance to nitrate, gluten, or milk;
* Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).

Primary outcomes:
measure: Macrovascular function (Flow mediated dilatation%)
timeFrame: up to 2 years
Secondary outcomes:
measure: Plasmatic concentrations of nitrate and nitrite (mmol/L)
timeFrame: up to 2 years
measure: Values of systolic and diastolic blood pressure (mmHg)
timeFrame: up to 2 years
measure: Values of heart rate variability (ms)
timeFrame: up to 2 years
measure: Values of heart rate (beats per minute)
timeFrame: up to 2 years
measure: Values of hand grip strength (kgF)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Cicero Jonas Rodrigues Benjamim, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: