louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06623045: Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes
Official title: Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength
Muscle Activation
Urinary Incontinence (UI)
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Functional fitness training (FFT) is a prominent exercise regimen, that has emerged as the dominant fitness trend of the 21st century , advocating high-intensity exercises with repetitive, impactful movements that often result in increased intra-abdominal pressure (IAP) and neuromuscular fatigue. This demanding training pattern, characterized by minimal rest pauses, has been associated with potential health concerns, particularly urinary incontinence (UI). In athletes, UI is intricately connected to the frequency of exposure to increased IAP during high-impact activities. These activities assume even greater significance in sports, particularly in FFT, where there is an increased frequency of impactful foot contact on the ground and intensive abdominal exercises, potentially correlating with the overload of the pelvic floor muscles and the emergence of dysfunctions. Therefore, this study aims to examine the effects of a 12-week training program focused on Kegel exercises performed with diaphragmatic breathing in nulliparous female FFT athletes. The central hypothesis postulates that after the 12-week intervention, these women will exhibit enhancements in both the muscular activation and contractile capacity of their pelvic floor, leading to a reduction in instances of urine leakage.


Eligibility criteria: Inclusion Criteria:

* Nulliparous FFT female athletes
* had been practicing FFT or weightlifting for at least 2 years
* train a minimum of 3 days/week
* had not previously performed pelvic floor exercises
* had no medical contraindications or previous pelvic floor surgeries

Exclusion Criteria:

* Any criterion that does not meet the inclusion criteria

Primary outcomes:
measure: Strength
timeFrame: From the enrollment to the end of treatment at 12 weeks
measure: muscle activation
timeFrame: From the enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Urinary incontinence (UI)
timeFrame: From the enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
References:
Clinical trial NCT03379545: 3D MR Versus 3D CT for Glenohumeral Arthritis
Official title: Preoperative Magnetic Resonance as an Alternative to Computed Tomography Three-Dimensional Imaging for Characterizing Bone Loss in Shoulder Arthroplasty Candidates With Glenohumeral Osteoarthritis: A Prospective, Blinded, and Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Glenohumeral Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 31
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: This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from glenohumeral OA;
* Radiographic evidence of severe glenoid erosion;
* Indication for TSA based on clinical exam;
* Patient is willing to participate by complying with pre-operative visit requirements;
* Patient is willing and able to review and sign a study informed consent form.

Exclusion Criteria:

* Prior arthroplasty at the affected shoulder;
* Patients with inflammatory arthritis;
* Patients with post-capsulorrhaphy arthritis;
* Patients with post-traumatic arthritis;
* Patients with rotator cuff tear arthropathy;
* Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedures;
* Patients who are pregnant;
* Patients with implanted medical devices that are contraindicated to exposure up to a 3.0-tesla magnetic field.

Primary outcomes:
measure: Glenoid Version
timeFrame: 3 Months
measure: Glenoid Inclination
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joseph D Zuckerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425645: Families Defeating Diabetes
Official title: Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Keywords: gestational diabetes
GDM
prevention
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include:

* the need to identify, then target specific at-risk populations
* significant time-delays before any program effects on T2DM incidence may manifest.

However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families.

FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site.

Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months.

Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.


Eligibility criteria: Inclusion Criteria:

* women aged 18-50 with recent GDM
* able to speak and write English
* overweight (BMI \>25 before pregnancy)
* significant other family members

Exclusion Criteria:

* women with Types 1 or 2 diabetes
* women with BMI under 25

Primary outcomes:
measure: Proportion of study subjects achieving a 7% weight loss
timeFrame: one year post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St Josephs Health Care
state: Ontario
Study officials:
References:
Clinical trial NCT05865145: Effects of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Elderly
Official title: Effects of Two Different Intensities of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Older Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese
Elderly
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants were randomly assigned to two groups prior to their second visit:

the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT).

The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined.

Group A will receive a program of high intensity interval training program Group B will receive a program of Low intensity interval training program


Eligibility criteria: Inclusion Criteria:

* could stand and walk for 30m without becoming out of breath.
* could walk safely without the aid of another person.
* body mass index (BMI) ≥ 30 kg/m2

Exclusion Criteria:

* uncontrolled preexisting health conditions such as:
* uncontrolled hypertension
* uncontrolled diabetes
* uncontrolled heart disease

Primary outcomes:
measure: Perceived Exertion
timeFrame: 4 weeks
measure: Exercise Adherence
timeFrame: 4 weeks
measure: Glucose level
timeFrame: 4 weeks
measure: calcium level
timeFrame: 4 weeks
measure: sodium level
timeFrame: 4 weeks
measure: potassium level
timeFrame: 4 weeks
measure: carbon dioxide level
timeFrame: 4 weeks
measure: chloride level
timeFrame: 4 weeks
measure: blood urea nitrogen (BUN) level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinic faculty of physical therapy at Cairo University
Study officials:
References:
Clinical trial NCT00190645: To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence
Official title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 600
Sex: FEMALE
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: The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.


Eligibility criteria: Inclusion Criteria:

Successfully completed the protocol for Study F1J-MC-SBAV.

-

Exclusion Criteria:

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

-

Primary outcomes:
measure: To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).
Secondary outcomes:
measure: To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire.
Other outcomes:
Locations:
city: Denver
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Colorado
city: Oakville
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559,1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Ontario
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 NCT01217645: Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
Official title: A Phase I, Open-label, Single-Centre Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Major depression disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study to assess the distribution, metabolism and excretion of \[14C\]AZD6765 after a single-dose intravenous administration.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a normal creatinine clearance of ≥60 mL/min
* Subjects who self-identify their race as Asian

Exclusion Criteria:

* History of any clinically significant medical, neurologic or psychiatric disease as judged by the investigator
* History of symptomatic orthostatic hypotension (ie, postural syncope)
* Subjects who have received any radiolabelled study drug within 12 months of the Screening Visit.
* Subjects who are monitored for radioactivity as part of their occupation
* Subjects who have been exposed to radiation levels above background, (eg, throughX-Ray examinations) of \>5mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1mSv per year of life.

Primary outcomes:
measure: The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
timeFrame: Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity
measure: The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765
timeFrame: Urine and feacal samples will be taken from predose until up to 240 hrs from start of infusion to assess radioactivity
Secondary outcomes:
measure: To identify and profile the metabolites in selected samples of urine, faeces and plasma following a single intravenous dose of 150 mg [14C] AZD6765
timeFrame: A Range from predose until up to 240 hrs from start of infusion.
measure: Safety and tolerability after a single IV administration of [14C] AZD6765 by assessing a panel of measures: adverse events, blood pressure and pulse, blood samples, urinalysis, hematology, clinical chem, physical exam, ECG and symptoms of suicidality.
timeFrame: A Range from predose until up to 240 hrs from start of infusion.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles, Inc.
name: Darren Wilbraham, MBBS, DCPSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724445: Empathy in Frames: Animated Cartoons To Reduce HIV Stigma Among South African Young Adults
Official title: Empathy in Frames: Assessing the Impact of Ethnic Concordance in Animated Cartoons on HIV/AIDS Stigma Among South African Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-related Stigma
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 1496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study looks at whether using cartoons that reflect the culture of South Africa can help change how young adults there think about HIV/AIDS. This study will test two types of cartoons in a two-arm (treatment, comparator) randomized controlled trial design-one with Black characters and one with White characters-to see how they affect people's attitudes and knowledge about HIV/AIDS. Randomly allocated participants will be Black seronegative South African adults between 18 and 35 years old. This group was chosen because they're a demographic disproportionately affected by HIV, they're at a high point in their lives for shaping and sharing beliefs, and they're also highly active online, which is where this study takes place.

The cartoons will show the daily struggles of the protagonist living with HIV/AIDS, and end with a call to action. The study aims to highlight how the characters' ethnicity influences how viewers feel about and remember the message. The investigators want to understand if seeing characters who look like them helps people understand and empathize more. The aim of this study is to learn how cultural representation can improve health communication and guide future efforts to reduce stigma in different communities. Ultimately, the investigators hope this study will contribute to better public health messages and create a more accepting environment for people with HIV/AIDS.


Eligibility criteria: Inclusion Criteria:

* Must self-identify as Black South African
* Must be HIV seronegative
* Age range: 18-35 years
* Must currently reside in South Africa
* Must have basic English language comprehension
* Must have internet access to view video content

Exclusion Criteria:

* Prior participation in HIV stigma reduction interventions
* HIV seropositive status
* Non-Black South African identity
* Outside target age range (18-35)

Primary outcomes:
measure: Attitudes towards HIV
timeFrame: Up to 14 days
measure: Health Ethnicity Perceptions
timeFrame: Up to 14 days
Secondary outcomes:
measure: Behavioral intentions
timeFrame: Up to 14 days
measure: HIV knowledge
timeFrame: Up to 14 days
measure: Viewer Engagement with Cartoon
timeFrame: 14 days
Other outcomes:
Locations:
city: Multiple Locations
country: South Africa
facility: Busara Center for Behavioral Economics
Study officials:
affiliation: Columbia University
name: Yanis Ben Amor, PhD
role: STUDY_CHAIR
affiliation: Columbia University
name: Adam Sacarny, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04738045: Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Official title: Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Keywords: Remdesivir
Lopinavir/ Ritonavir
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2021-02-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.

Detailed description: Aim of the study

1. To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
2. To detect time to improvement in oxygenation among both groups.
3. To detect duration of hospitalization and mortality rate in both groups.
4. To detect incidence and duration of mechanical ventilation in both treatment arms.
5. To monitor of adverse events of both drugs.

Eligibility criteria: Inclusion Criteria:

* Hospitalized adult patients with pneumonia evidenced by chest CT scan.
* Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
* And at least one of the following:

  1. Respiratory frequency ≥30/min.
  2. Blood oxygen saturation ≤93% on room air (RA).
  3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
  4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

Exclusion Criteria:

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 5-fold the upper limit of the normal range.
* Pregnancy.
* Known hypersensitivity to drugs or any component of the formulation.
* Serious co-morbidity, including: Hepatic patients child Pugh class C.

Primary outcomes:
measure: Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
timeFrame: "through study completion, an average of 3 months"
Secondary outcomes:
measure: Monitoring of adverse events.
timeFrame: "through study completion, an average of 3 months"
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef University
Study officials:
affiliation: Beni-Suef University
name: Rania M Sarhan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575145: Helping Hospitalized Patients Quit Smoking
Official title: Helping Hospitalized Patients Quit Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Abuse Cigarette
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 600
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 study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.

Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.

The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.


Eligibility criteria: Inclusion Criteria:

Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up

Exclusion Criteria:

Current active treatment for tobacco use initiated prior to hospitalization

Primary outcomes:
measure: 7-day point prevalence tobacco abstinence at 6 months after hospitalization
timeFrame: 6 months after hospitalization
Secondary outcomes:
measure: Self-efficacy
timeFrame: Immediately after the delivery of the brief intervention (day of enrollment)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan MB, Borah BJ, Moriarty JP, Warner DO. Association between smoking cessation and post-hospitalization healthcare costs: a matched cohort analysis. BMC Health Serv Res. 2019 Dec 2;19(1):924. doi: 10.1186/s12913-019-4777-7.
citation: Nolan MB, Borah BJ, Moriarty JP, Warner DO. Economic Analysis of a Geographically Defined Cohort of Hospitalized Patients Who Smoke. Mayo Clin Proc. 2018 Aug;93(8):1034-1042. doi: 10.1016/j.mayocp.2018.02.022. Epub 2018 Jul 4.