louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06599190: Effect Of Abdominal Hypopressive Training On Stress Urinary Incontinence
Official title: Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Stress Urinary Incontinence
Keywords: stress incontinence, and female athelete
Lead sponsor: Badr University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They will be randomly distributed into 2 groups equal in numbers:

Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.
Primary purpose: TREATMENT

Brief summary: Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.

Detailed description: They will be randomly distributed into 2 groups equal in numbers:

Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.

Eligibility criteria: Inclusion Criteria:

1. Female athletes suffering from SUI.
2. They will be diagnosed with SUI using bladder stress test.
3. Their ages will range from 14-18 years old.
4. Their body mass index (BMI) will range from 18.5-24.9 kg/m2.
5. They are single females.

Exclusion Criteria:

The female athlete will be excluded if they had:

1. Urinary tract infection.
2. Family history of genito-urinary tract cancer.
3. Diabetes mellitus.

Primary outcomes:
measure: Assessment of urine loss
timeFrame: 24 hours pad test for12 weeks
measure: assesment of pelvic floor muscle contraction and tonning
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of symptoms and health related quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Cairo
country: Egypt
facility: El Zohour Club
state: Cairo
Study officials:
affiliation: professor doctor
name: Abeer ElDeeb, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04419090: Cascade Genetic Testing of Familial Hypercholesterolemia
Official title: Cascade Genetic Testing of Familial Hypercholesterolemia: the CATCH Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hypercholesterolemia
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Heart Foundation
First posted: 2020-06-05
Enrollment: 379
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Familial hypercholesterolemia (FH) is a frequent genetic disorder (1/200) associated with an increased risk of early-onset myocardial infarction. To improve detection and treatment of patient with FH, cascade genetic testing in families is recommended by many cardiovascular prevention guidelines. However, the implementation of national genetic cascade screening is challenging, because legal protection to guarantee privacy of data do not authorize physicians to directly contact at-risk relatives. Using current mobile information technologies and a centralized web-based platform, we designed an ethical genetic cascade screening program for FH to be tested in Switzerland.


Eligibility criteria: Inclusion Criteria:

* patients with severe hypercholesterolemia and familial or personal history of early-onset cardiovascular disease = Dutch Lipid Clinic Network score (DLNC) \>= 6 points.

Exclusion Criteria:

* Patients without at least one contactable first-degree family members

Primary outcomes:
measure: the yield of detection of familial hypercholesterolemia (FH)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Center for primary care and public health (Unisanté), University of Lausanne
Study officials:
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: David Nanchen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834690: Uses of Immunosuppression Therapy in Patients With Liver Transplantation
Official title: Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evidence of Liver Transplantation
Keywords: Liver transplantation/epidemiology
Liver transplantation/pharmacology
Health status/drug effects
Agents, immunosuppressive agents
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 314
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects: Patients who had liver transplantation in Kaohsiung Chang Gung Memorial Hospital

Brief summary: Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.

Detailed description: Specific aims are proposed to achieve in this study:

1. To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan.
2. To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.

Eligibility criteria: Aim 1:

Inclusion Criteria:

* age at liver transplantation is at least 20 years

Aim 2:

Inclusion Criteria:

* age at liver transplantation is at least 20 years

Exclusion Criteria:

* deceased patient
* cannot obtain inform consent
* age \<20 years

Primary outcomes:
measure: incidence of graft and patient mortality, treatment-related complications
timeFrame: 5 years
Secondary outcomes:
measure: health-related quality of life
timeFrame: 5 years
Other outcomes:
measure: quality-adjusted life expectancy (QALE), loss-of-QALE
timeFrame: 5 years
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chien-Ning Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00684190: Drug Interaction Study Between AZD3355 and Nexium
Official title: An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophageal Reflux Disease
Keywords: Reflux Inhibitor
GERD
PPI Interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
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 evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Females no childbearing potential
* Clinically normal physical findings

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during day 7 each treatment period
Secondary outcomes:
measure: 4-BOH cholesterol
timeFrame: Sampling occasions during day 7 one treatment period (AZD3355 alone)
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Eva Ersdal, PhD
role: STUDY_DIRECTOR
affiliation: Quintiles AB, Uppsala, Sweden
name: Jan Vouis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.
Clinical trial NCT01390090: Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections
Official title: Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections: Does Accuracy Improve Efficacy?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Subjects Will Have Failed Conservative Treatment
Keywords: piriformis muscle
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine.

Brief summary: Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be scheduled for a piriformis muscle (PM) corticosteroid injection.


Eligibility criteria: Inclusion Criteria:

* Subject Scheduled to receive piriformis injection for buttock pain
* Baseline pain visual analogue scale (VAS) value of at least 4 on a scale of 0-10 points
* Subjective complaint of pain in the buttocks with radiation down the thigh and/or leg
* Objective clinical diagnosis of piriformis syndrome
* Reproduction of pain with maneuvers that stretch or contract the piriformis muscle over the sciatic nerve

Exclusion Criteria:

* Litigation
* Those receiving long-term (\>6 months) remuneration for their pain or seeking new or increased long-term remuneration
* Those unable to read English and complete the assessment instruments
* Diagnosis of systemic inflammatory arthritis (e.g. rheumatoid, lupus)
* Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
* Possible pregnancy or other reason that precludes the use of fluoroscopy. Fluoroscopy is the current standard of care for piriformis injections. Its use in this study is no different than the standard of care and will be no different if the subjects are enrolling in the study or not
* Contra-indication to corticosteroid, including known allergies or sensitivities

Primary outcomes:
measure: Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle.
timeFrame: Following fluoroscopic guidance of the needle placement and prior to the injection, the needle position will be evaluated by ultrasound.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: D J Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06363890: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia
Official title: Frequency and Etiology of Travelers' Diarrhea in Australian Adult Tourists Traveling to Southeast Asia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Travelers Diarrhea
Keywords: travelers diarrhea
australian
epidemiology
Lead sponsor: Lumen Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1200 Australian adult tourists traveling to Southeast Asia

Brief summary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.


Eligibility criteria: Inclusion Criteria:

* Adult aged \> 18 years residing in Australia.
* Planned travel for 14 to 28 days starting in the next 30 days to selected countries in Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam.
* Willing to participate in the clinical study and available for all planned study activities through approximately 28 days post-travel.
* Access to a smartphone and mobile phone services while traveling (either by local SIM card, WiFi, or international roaming service on the individual's home-country mobile phone).

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent.

Primary outcomes:
measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: AK Clinical Research
Study officials:
References:
Clinical trial NCT05603390: Heart Failure With Mildly Reduced Ejection Fraction Registry
Official title: Heart Failure With Mildly Reduced Ejection Fraction Registry (HARMER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study consecutively includes patients with heart failure with mildly reduced ejection fraction (HFmrEF) from 2015 to 2022.

Brief summary: Heart failure (HF) affects about 1% of patients younger than 55 years, whereas the prevalence of HF increases \> 10% in patients with at least 70 years of age. Despite HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF), the clinical significance of HF with mildly reduced ejection fraction (HFmrEF) has gained more importance within the past years. Those patients are characterized by a left ventricular ejection fraction (LVEF) of 41-49%. However, within the current European guidelines, limited treatment recommendations in this subgroup of HF are yet available as a consequence of the limited number of studies in this field. The "Heart Failure With Mildly Reduced Ejection Fraction Registry" aims to characterize patients with HFmrEF and investigated the prognostic impact of interventional and pharmacological therapies in this subgroup of HF patients.


Eligibility criteria: Inclusion Criteria:

* Patients with HFmrEF (i.e., LVEF 41-49%)
* Patients with at least 18 years of age

Exclusion Criteria:

* Patients younger than 18 years of age

Primary outcomes:
measure: All-cause mortality
timeFrame: 2 years.
Secondary outcomes:
measure: Change of LVEF
timeFrame: 2 years.
measure: Change of NT-pro BNP
timeFrame: 2 years.
measure: Heart-failure related hospitalization
timeFrame: 2 years.
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
Study officials:
affiliation: First Department of Medicine, University Medical Centre Mannheim, Germany.
name: Michael Behnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409590: Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Official title: Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
weight gain
atypical neuroleptics
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia
* Atypical neuroleptics

Exclusion Criteria:

* Medical illness preventing exercise

Primary outcomes:
measure: Weight loss
timeFrame: One year
Secondary outcomes:
measure: Abdomen circumference
timeFrame: One year
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
state: Ramat Gan
Study officials:
affiliation: Sackler School of Medicine
name: Revital Amiaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005890: Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: immunologic disorders and infectious disorders
rare disease
sepsis
septic shock
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2000-06-05
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: OBJECTIVES:

I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children with septic shock.

II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in children with adrenal dysfunction and septic shock.

Detailed description: PROTOCOL OUTLINE:

Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU. Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes. Corticotropin is measured by immunoradiometric assay and cortisol is measured by radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded at baseline and at 60 minutes.

Patients receive routine management for septic shock and multiple organ system failure.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients admitted to the PICU with septic shock; Hypotension (systolic blood pressure less than 2 standard deviations below age normal) plus 3 or more of the following: temperature greater than 38 or less than 36 degrees Celsius; heart rate greater than 90th percentile for age; respiratory rate greater than 90th percentile for age; WBC greater than 12,000/mm3 or less than 4,000/mm3 or greater than 10% band forms; perfusion abnormalities including lactic acidosis, oliguria, or an acute alteration in mental status

Arterial or central venous catheter in place

--Prior/Concurrent Therapy--

At least one month since prior corticosteroids

--Patient Characteristics--

Renal: No nephrotic syndrome requiring glucocorticoids

Pulmonary: No asthma requiring glucocorticoids

Other: No condition requiring glucocorticoids (e.g., adrenal insufficiency); No uncontrolled diabetes mellitus; No prior adrenal dysfunction (plasma cortisol concentration less than 19 mcg/dL 30 and 60 minutes post corticotropin stimulation); No hypersensitivity to corticotropin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Richard J. Brilli
role: STUDY_CHAIR
References: