louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02785016: Surgical Management for Suburethral Slings
Official title: Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Suburethral Sling
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have surgically-correctable Stress Urinary Incontinence and undergo a suburethral sling operative procedure.

Brief summary: This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

Detailed description: The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

Eligibility criteria: Inclusion Criteria:

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. The subject has current urinary tract infection.

Primary outcomes:
measure: Cure/improvement rate
timeFrame: 3 months
Secondary outcomes:
measure: Subjective symptom assessment by visual analogue scale
timeFrame: 3 and 6 months
measure: Post-Operative Pain Assessment
timeFrame: 1 day
measure: Standing Cough Stress Test
timeFrame: baseline, 3 and 6 months
measure: King Health Questionnaire
timeFrame: pre-operation, 3 and 6 months
measure: International Consultation on Incontinence Questionnaire
timeFrame: pre-operation, 3 and 6 months
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Blasenzentrum, Cantonal Hospital
state: Thurgau
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker Viereck, Physican
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794416: Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation
Official title: Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* failed initial catheter ablation
* paroxysmal atrial fibrillation

Exclusion Criteria:

* chronic lung disease
* body mass index \>35
* longstanding atrial fibrillation 1 year
* previous stroke or transient ischemic attack
* left atrial thrombus
* left atrial size \>65 mm
* left ventricular ejection fraction \<35%

Primary outcomes:
measure: freedom from any atrial arrhythmia
timeFrame: 12 months
Secondary outcomes:
measure: rate of significant adverse events (SAEs)
timeFrame: 12 months
measure: atrial fibrillation burden by ILR
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokushalov E, Romanov A, Elesin D, Bogachev-Prokophiev A, Losik D, Bairamova S, Karaskov A, Steinberg JS. Catheter versus surgical ablation of atrial fibrillation after a failed initial pulmonary vein isolation procedure: a randomized controlled trial. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1338-43. doi: 10.1111/jce.12245. Epub 2013 Sep 9.
Clinical trial NCT00032916: Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers - 1
Official title: Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Drug Administration Schedule
Infusions, Intravenous
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

Detailed description: This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

Eligibility criteria: Inclusion Criteria:

Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse.

Exclusion Criteria:

Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

Primary outcomes:
measure: Pharmacokinetic parameter comparison
measure: plasma concentration
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890616: Constipation and Gut Transit in DMD Patients
Official title: Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
DMD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DMD patients 5-18 yr of age who are seen in a large interdisciplinary DMD center.

Brief summary: In this research study the investigators want to screen Duchenne Muscular Dystrophy (DMD) patients for signs and symptoms of constipation in patients over 18.

The investigators hypothesized:

* DMD patients have a high prevalence of constipation than in the general population.
* Prevalence of constipation will increase with age and with worsening functional status.

Detailed description: The following procedures will take place during the study.

Constipation Assessment:

* The patient will be asked to complete a questionnaire about any symptoms of constipation.
* A physician from the study team will perform an abdominal physical exam
* The patient will have routine x-rays that monitor for spine compression fractures. These films will also be used to assess stool content.

Clinical Information The following information will also be collected during the clinic visit ;

* Age at diagnosis and genetic mutation
* Age at loss of ambulation if applicable
* Medications
* Functional status

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Duchenne Muscular Dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation).
* Age greater than or equal to 18 years old

Exclusion Criteria:

* None

Primary outcomes:
measure: GI transit times
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ajay Kaul, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03899116: Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients
Official title: Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tourniquet
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet

Brief summary: Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice

Detailed description: Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:

G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.

G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.

G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet

Exclusion Criteria:

* BMI ≥35Kg/ m2
* patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
* contraindication to tourniquet insertion
* patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: 15 minutes after start of deflation of cuff
Secondary outcomes:
measure: hypotension
timeFrame: 15 minutes after start of deflation of cuff
measure: cardiac output
timeFrame: 15 minutes after start of deflation of cuff
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT05091216: The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients
Official title: A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leprosy
Hansen's Disease
Xerostomia
Plaque
Keywords: Leprosy
Hansen's disease (HD)
traditional Chinese medicine mouthwash
oral health
xerostomia
Plaque Index, PLI
Lead sponsor: Lo-Sheng Sanatorium
Sponsor class: OTHER_GOV
First posted: 2021-10-25
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.

Detailed description: The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash.

Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.

Eligibility criteria: Inclusion Criteria:

* Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
* Compliant with the presence of more than four teeth in each of the upper and lower four regions
* Those who have not used antibiotics and mouthwash two months before the test

Exclusion Criteria:

* Moderate to severe dementia
* CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
* Those with a score of less than 17 on the MMSE Simple Mind Scale
* Nasogastric Tube Inserters
* Those who are allergic to mouthwash
* Those who are on course of antibiotics and steroids
* Those who have had dental cleansing within one month

Primary outcomes:
measure: Plaque Index, PLI
timeFrame: 21 days
measure: Xerostomia questionnaire
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Lo-Sheng Sanatorium
Study officials:
affiliation: Lo-Sheng Sanatorium
name: Wei-Hung Hsu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03823716: Inadvertent Hyperventilation During Intraoperative Care in Neonates
Official title: Inadvertent Hyperventilation During Intraoperative Care in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 112
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at Nationwide Children's Hospital.

Brief summary: In order to evaluate current anesthetic practice in the care of preterm infants and neonates, the investigators will retrospectively review surgical procedures in infants who are less than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or in situ upon arrival in the operating room. They will evaluate the mode of ventilation (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP, inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to determine the average minute ventilation.


Eligibility criteria: Inclusion Criteria:

* neonates (\<60 weeks post-conceptual age) undergoing non-cardiac operative procedures in which arterial access is generally present (exploratory laparotomy or thoracotomy)

Exclusion Criteria:

* none

Primary outcomes:
measure: Decreased Partial Pressure of Carbon Dioxide (PaCO2)
timeFrame: During surgical procedure (average of 2-3 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Kristin Chenault, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chenault K, Wakimoto M, Miller R, Tobias JD. The Incidence and Severity of Hypocarbia in Neonates Undergoing General Anesthesia. Respir Care. 2020 Aug;65(8):1154-1159. doi: 10.4187/respcare.07382. Epub 2020 Mar 17.
Clinical trial NCT06207916: International Survey of Childbirth-Related Trauma - Swedish Part
Official title: International Survey of Childbirth-Related Trauma - Swedish Part
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childbirth-related PTSD
PTSD
Postnatal Depression
Fear of Childbirth
Post Traumatic Stress Disorder
Postpartum Sadness
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 619
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who had given birth at the participated clinics and whom answered to the inclusion and exclusion criteria

Brief summary: The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are:

* What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample?
* What are the risk factors for postnatal mental ill-health?

Additional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised.

Participants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.


Eligibility criteria: Inclusion Criteria: having given birth 6-16 weeks previously -

Exclusion Criteria: having given birth to a child that did not survive

-

Primary outcomes:
measure: Prevalence of childbirth-related PTSD
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
Study officials:
References:
Clinical trial NCT00063024: Program to Prevent Osteoporosis in Girls
Official title: Behavioral Strategies to Prevent Osteoporosis in Girls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Bone health
Weight-bearing physical activity
Calcium
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-06-20
Enrollment: 322
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Osteoporosis is a condition defined by decreased bone mass. Osteoporosis generally affects older women and can lead to bone fractures. One way to prevent osteoporosis is to build strong, healthy bones during childhood. This study will evaluate a program designed to improve girls' bones. The program encourages eating foods rich in calcium and participating in physical activity.

Detailed description: Osteoporosis affects more than 25 million people in the United States. The majority of bone fractures in older women are related to osteoporosis. Calcium intake and physical activity are two modifiable behaviors associated with peak bone mass. Interventions targeting these behaviors among youth have tremendous public health potential for preventing osteoporosis. This study will assess the feasibility and effectiveness of a 2-year behavioral program designed to increase calcium intake and physical activity among girls ages 9 to 11.

Thirty Girl Scout troops will be recruited for the study. Girls will be randomized either to the eating and exercise behavior change program or to a control group. Program components focus on behavioral skills development, goal setting, and self-monitoring for dietary calcium intake and physical activity. The program also works to increase social support from peers and parents. The program will take place during 10 weeks of both the 5th and 6th grade years. The program also includes supporting programs during winter and summer breaks. Outcome assessments will be conducted at baseline, and at 6, 12, and 24 months. Primary outcomes will include dietary calcium intake, physical activity, and bone mineral density.

Eligibility criteria: Inclusion Criteria

* Member of a Girl Scout troop with at least eight 5th grade girls
* Member of the Greater Minneapolis or St. Croix Valley Girl Scout organization
* Only troops with unanimous parental consent will be included in the trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Division of Epidemiology, School of Public Health, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Simone A. French, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: