louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06637475: Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
Official title: Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaginal Laxity
Keywords: vaginal laxity, pelvic floor, electrical stimulation
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list).
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in women with vaginal laxity.


Eligibility criteria: Inclusion Criteria:Complaining of vaginal laxity To be between 18-60 years old, Being sexually active, Volunteering to participate in the study, Becoming literate -

Exclusion Criteria:

Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Having undergone surgery for POP/incontinence (within the last 1 year) Pregnancy presence Having enough laxity to require surgery Having a neurological disorder Receiving estrogen therapy

-

Primary outcomes:
measure: Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
timeFrame: Change from basline at 8 weeks
Secondary outcomes:
measure: Pelvic floor symptoms Pelvic Floor Distress Inventory-20 (PTDE-20)
timeFrame: Change from basline at 8 weeks
measure: Sexual function Female Sexual Function Index (FSFI)
timeFrame: Change from baseline at 8 weeks
measure: Pelvic floor muscle morphometry (levator ani thickness)
timeFrame: Change from baseline at 8 weeks
measure: Pelvic floor muscle strength and endurance
timeFrame: Change from baseline at 8 weeks
measure: Vaginal wall and mucosa thickness
timeFrame: Change from basline at 8 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT02200575: Pharmacovigilance and Patient Compliance in Hypertensive Patients
Official title: Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 10333
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: Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists

Brief summary: Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.


Eligibility criteria: Inclusion Criteria:

- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)

Exclusion Criteria:

- corresponding to the contraindications listed in the summary of product characteristics of the drug

Primary outcomes:
measure: Assessment of changes in heart rate
timeFrame: Baseline, up to 8 weeks after start of treatment
measure: Assessment for patients with changes in laboratory values
timeFrame: Baseline, up to 8 weeks after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 8 weeks after start of treatment
Secondary outcomes:
measure: Changes in mean systolic and diastolic blood pressure values
timeFrame: Baseline, up to 8 weeks after start of treatment
measure: Changes in mean systolic and diastolic blood pressure values
timeFrame: Baseline, up to 8 weeks after start of treatment
measure: Evaluation of treatment compliance as percentage of tablets planned
timeFrame: Up to 8 weeks after start of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01425775: The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
disease activity markers
vitamin D
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin D supplementation.

248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18, TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12 months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were classified as vitamin D insufficiency, and levels \< 10 ng/ml as vitamin D deficiency.The mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women and males of the same body mass index and ethnicity

Exclusion Criteria:

Patients with:

* other inflammatory disorders,
* hepatic disease
* renal disease
* malignant disease.

Primary outcomes:
measure: Decrease in SLE disease activity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.
Clinical trial NCT00962975: A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is \<100.


Eligibility criteria: Inclusion Criteria:

* adult patients \>/=18 years of age
* previous participation in other donor protocol
* chronic hepatitis B
* no other anti-HBV treatment after completion of previous donor protocol
* female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study

Exclusion Criteria:

* hepatic decompensation (Child-Pugh class B and C)
* antiviral, antineoplastic or immunomodulatory treatment
* evidence of alcohol and/or drug abuse

Primary outcomes:
measure: The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
timeFrame: assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
Secondary outcomes:
measure: Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
timeFrame: assessed every 2 months on treatment and up to week 24 of follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Grafton
country: New Zealand
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01993875: Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Official title: A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo Pharma Americas, LLC
name: Takeda
name: Sucampo AG
First posted: 2013-11-25
Enrollment: 164
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: To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.


Eligibility criteria: Inclusion Criteria:

* Medically-confirmed diagnosis of chronic idiopathic constipation
* Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
* Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

* Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.

Primary outcomes:
measure: Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
timeFrame: within 1 week
Secondary outcomes:
measure: Consistency of SBMs at Week 1
timeFrame: at Week 1
measure: Overall Stool Consistency at Week 1
timeFrame: at Week 1
measure: Mean Change From Baseline in Stool Consistency at Week 1
timeFrame: Baseline and Week 1
measure: Overall Straining at Week 1
timeFrame: Week 1
measure: Mean Change From Baseline in Straining at Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: DeLand
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: Marlton
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Salt Lake City
country: United States
state: Utah
city: West Bend
country: United States
state: Wisconsin
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT01451775: Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Official title: Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 18
Sex: ALL
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: Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
measure: Maximum Measured Concentration (Cmax)
timeFrame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Secondary outcomes:
measure: Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.
timeFrame: Screening until end of trial, average of 45 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.79.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02673775: Air Pollution Study: The Effect of Ozone on the Lung
Official title: Activated Macrophages and Ozone Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Air Pollution
Keywords: Macrophage
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2016-02-04
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Detailed description: Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood, urine, and exhaled breath samples will also be collected at each visit.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women

Exclusion Criteria:

* Cardiovascular disease
* Respiratory disease
* Diabetes
* Pregnancy
* HIV infection
* History of smoking within the last 5 years
* Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
* Orthopedic or rheumatological conditions that would interfere with cycle use

Primary outcomes:
measure: Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.
timeFrame: 24 hours after exposure.
measure: Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.
timeFrame: 48 hours after exposure
measure: Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
timeFrame: 72 hours after exposure.
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Environmental and Occupational Health Sciences Institute
state: New Jersey
Study officials:
affiliation: Rutgers School of Public Health
name: Howard M. Kipen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03700775: Hypertension Management Using Telemonitoring
Official title: Remote Hypertension Management Using Home Blood Pressure Telemonitoring and a Standardized Treatment Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Telemedicine
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Singe center prospective cohort study
Primary purpose: TREATMENT

Brief summary: This is a prospective study evaluating the feasibility and safety of remote hypertension management using a central telemonitoring program among patients with elevated blood pressure (BP) at the University of Mississippi Medical Center (UMMC).

Detailed description: Patients with elevated BP, identified by the electronic medical record, will be recruited for study enrollment. Patients will be mailed a telemonitoring kit including an electronic tablet equipped with a wireless BP cuff that transmits measurements directly to the UMMC electronic medical record and monitored by the UMMC Center for Telehealth. Patients will participate in a 6 month intervention period during which they will transmit daily BP recordings with regular contact by a Telehealth nurse coordinator who will provide education and encourage healthy lifestyle habits. Every 2 weeks BP medications will be adjusted according to an evidence-based treatment algorithm managed by the Center for Telehealth pharmacist using a standardized physician-approved protocol. Data analysis will track metrics of study enrollment, study completion, safety, therapeutic intensification, and BP change from baseline.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Patient of UMMC clinician approving the study
3. At least 2 clinic encounters in the past 12 months with systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg

Exclusion Criteria:

1. Stage 4 or 5 chronic kidney disease
2. Systolic heart failure (LVEF \<50%) or major cardiovascular event (MI, stroke) within 3 months
3. Resistant hypertension (prescribed 3 or more antihypertensive medications at target doses) or known secondary cause of hypertension
4. Pregnancy or inability/unwillingness to use birth control for women of child-bearing potential
5. Institutionalized, dementia, limited life expectancy, uncontrolled mental illness, substance abuse, or other conditions that would prohibit ability to perform regular home BP monitoring

Primary outcomes:
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
measure: BP control rates
timeFrame: 12 months
measure: Antihypertensive medication adjustments
timeFrame: 6 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References:
Clinical trial NCT01892475: TAKing Steps for Incentives
Official title: TAKing Steps for Incentives (TAKSI) - A Randomized Controlled Trial to Motivate and Sustain Physical Activity Using Financial Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Incentives
Keywords: Physical Activity
Incentives
Mental Accounting
Older adults
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 314
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the overall effects of incentives on physical activity among older taxi drivers, and whether mental accounting exists in this context.

Detailed description: As part of the 4-month Randomized Controlled Trial, participating taxi drivers will be assigned to 1 of 2 groups where they will receive either cash or taxi rental credits for meeting specified monthly step goals measured via a step counter. Subsequently, for an additional 3 months, drivers will be incentivized to wear step counters to test if effects of the rewards are sustained once the reward is no longer in place. Effects will be quantified in terms of step activity; and in terms of changes in Body Mass Index (BMI), Resting Heart Rate (HR), Blood Pressure (BP), self-reported General Health, Health-Related Quality of Life (HR-QOL) and work productivity.

Eligibility criteria: Inclusion Criteria:

* Must be a taxi driver who is a hirer, and who drives for at least 8 hours daily over 5 days
* Aged between 50 to 75
* English/Mandarin-speaking

Exclusion Criteria:

* Report difficulty doing 10 minutes of aerobic activities without stopping, walking up 10 stairs without stopping or performing basic activities of daily living
* Have any medical conditions that limit their ability to walk as a means of physical activity

Primary outcomes:
measure: Steps taken
timeFrame: 7 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 7 months
measure: Resting Heart Rate
timeFrame: 7 months
measure: Blood Pressure
timeFrame: 7 months
measure: Self-reported General Health
timeFrame: 7 months
measure: Health-Related Quality of Life (HR-QOL)
timeFrame: 7 months
measure: Work Productivity
timeFrame: 7 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Graduate Medical School
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Eric A Finkelstein, Ph.D, M.H.A.
role: PRINCIPAL_INVESTIGATOR
References: