louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03027115: Hernia Surgery Urinary Retention
Official title: Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hernia
Urinary Retention
Lead sponsor: Memorial Health University Medical Center
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to 1 of 2 possible arms, control and treatment
Primary purpose: PREVENTION

Brief summary: Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.

Detailed description: The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.

Eligibility criteria: Inclusion Criteria:

* Male
* 18 years of age
* Presenting with hernia requiring surgical intervention

Exclusion Criteria:

* Intolerability of tamsulosin or related drugs
* Investigator discretion
* Unwillingness or inability to comply with protocol procedures and assessments

Primary outcomes:
measure: Post-operative urinary retention
timeFrame: 2 weeks
Secondary outcomes:
measure: Effect of IPSS
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
Study officials:
References:
Clinical trial NCT00260715: A Community-Based Intervention With Popular Opinion Leaders (C-POL) in Texas
Official title: A Community-Based Intervention With Popular Opinion Leaders (C-POL) in Texas to Achieve Syphilis Elimination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Sexually Transmitted Diseases
Keywords: Risk behavior
Sexually Transmitted Diseases
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Texas A&M University
First posted: 2005-12-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual partners, concurrent sexual relationships, and exchange of sex for drugs or money will decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about highly relevant risk-factors, information sources and resources will increase significantly; and 3) syphilis morbidity will decrease significantly in the intervention community as compared to the comparison community.

Detailed description: The C-POL in Texas project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. The study is being implemented in Texas (Dallas and Houston) with residents of a housing developing and the surrounding community.

The intervention model used for this study is the Popular Opinion Leader (POL) model, which is effective at reducing new HIV infections. The intent of this study was to determine the effectiveness of a diffusion model (e.g. POL) at reducing syphilis infections in affected communities.

For the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. Prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional STDs. During each assessment, cross-sections of the community members were sampled.

Eligibility criteria: Inclusion Criteria:

* Community members who live and/or frequent the affected community. The affected community was one that had significant syphilis morbidity at the onset of the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in syphilis prevalence in affected community.
Secondary outcomes:
measure: Change in risk behaviors, and health care seeking.
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A& M University
state: Texas
Study officials:
affiliation: CDC/NCHSTP/DSTDP/BIRB
name: Samantha Williams, Ph.D.
role: STUDY_CHAIR
affiliation: Texas A&M University
name: Nilesh Chatterjee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268315: A Brief Parental Intervention on Learning and Education in Childhood Cancer
Official title: Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Hyundai Hope On Wheels
First posted: 2022-03-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.

Detailed description: After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.

Eligibility criteria: Inclusion Criteria:

* parent(s) or legal guardian(s) of children with cancer
* preferred language for oral and written communication is English
* 18 years of age or older
* 1 or 2 parents or legal guardians can participate for each child

The child must also meet the following for the parent(s)/legal guardian(s) to participate:

* diagnosis of cancer
* child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
* child is between the age of 3 and 14
* child resides in New Mexico

Exclusion Criteria: Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth \& Families Department).

Primary outcomes:
measure: Feasibility of study recruitment and enrollment
timeFrame: Through study completion, up to 2 years
measure: Fidelity to the intervention protocol
timeFrame: at time of intervention (day 1)
measure: Acceptability of the intervention
timeFrame: immediately post-intervention (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Eric Zimak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349815: JAYDESS Drug Utilization Study in Sweden
Official title: Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Drug Utilization Study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2015-01-29
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in Sweden

Brief summary: * To describe characteristics (demographic, clinical, social) of first time users of Jaydess
* To estimate the duration of use of Jaydess
* To study switching patterns, e.g. what are the hormonal contraceptive methods used before and what are the methods after discontinuing Jaydess
* To study off-label use of Jaydess


Eligibility criteria: Inclusion Criteria:

* Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Duration of use of JAYDESS
timeFrame: Up to 6 years
measure: Indication for use
timeFrame: At insertion
Secondary outcomes:
measure: Age at insertion and removal
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03528915: Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates
Official title: Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmia Neonatorum
Keywords: neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 881
Sex: ALL
Minimum age (years): 36
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns

Brief summary: The French guidelines for the use of Rifamycine eye drops in delivery room to prevent neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of conjunctivitis should be treated, compared to previous guidelines, treating all newborns. currently, there are no data describing risk factors for neonatal conjunctivitis. This study evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.


Eligibility criteria: Inclusion Criteria:

* Newborns at the University Hospital of Amiens\> 36SA,
* Admitted in maternity at the exit of nursery

Exclusion Criteria:

* Newborns at the Amiens University Hospital \<36SA
* Eye drops for any medical reason within the first day of life.

Primary outcomes:
measure: Occurrence of conjunctivitis during the first 8 days of life in newborns
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT03279315: An Iodine Balance Experiment
Official title: Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Deficiency
Nutritional Requirements
Keywords: Iodine
Balance experiment
EAR
Chinese women
Euthyroid
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants received a diet with iodized table salt or non-iodized table salt
Primary purpose: BASIC_SCIENCE

Brief summary: A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.

Detailed description: The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.

Eligibility criteria: Inclusion Criteria:

* The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.

Exclusion Criteria:

* The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.

Primary outcomes:
measure: Total iodine intake and total iodine excretion
timeFrame: 12 days
measure: Total iodine excretion
timeFrame: 12 days
measure: urinary iodine concentration (UIC)
timeFrame: At the beginning of the experiment
measure: Thyroid function
timeFrame: At the beginning of the experiment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04702815: Visual Dependence and Multisensory Balance Rehabilitation After Stroke
Official title: Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Balance; Distorted
Gait, Unsteady
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic stroke patients with the first stroke will be recruited from the 3 departments of physical and rehabilitation medicine, regional hospitals.

Brief summary: This cross-sectional study aims to investigate the prevalence of post-stroke visual dependence, and the effects of visual dependence on balance and gait. It also determines whether visual dependence could differentiate stroke patients with a history of falls from without.

Detailed description: Stroke participants will be recruited to measure the level of visual dependence, muscle strength, neurological recovery, balance ability, vertigo symptom, gait pattern and activities of daily living. This will calculate the prevalence of post-stroke visual dependence, and investigate the negative impact of visual dependence on balance and walking functions. This also determines whether the value of visual dependence could differentiate stroke patients with a history of falls from without a history of falls.

Eligibility criteria: Inclusion Criteria:

* 1) first stroke with 20-80 years of age
* 2) the time since onset is more than 6 months
* 3) can walk independently at least 10 meters without any walking devices and orthosis
* 4) normal cognitive function with scoring more than 24 on the Mini Mental State Examination scale
* 5) can understand and follow commands
* 6) can give informed consent

Exclusion Criteria:

* 1) other neurological disorders which could affect balance assessment
* 2) cerebellar stroke
* 3) diagnosis with central or peripheral vestibular diseases.

Primary outcomes:
measure: Perceived visual dependence
timeFrame: Baseline
measure: Postural visual dependence
timeFrame: Baseline
measure: A history of falls
timeFrame: Baseline
Secondary outcomes:
measure: Physical impairment of paretic leg and foot
timeFrame: Baseline
measure: Five Times Sit to Stand Test
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: Baseline
measure: Timed Up and Go test
timeFrame: Baseline
measure: Modified Clinical Test of Sensory Integration and Balance
timeFrame: Baseline
measure: Falls Efficacy Scale - International
timeFrame: Baseline
measure: Situational Vertigo Questionnaire
timeFrame: Baseline
measure: Gait pattern
timeFrame: Baseline
measure: Barthel index
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Shu-Chun Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859115: Effects of TENS on Myocardial Protection in Patients Undergoing AVR
Official title: Effects of TENS on Myocardial Protection in Patients Undergoing AVR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Protection
Keywords: transcutaneous electrical nerve stimulation
sevoflurane
propofol
anesthesia
myocardial protection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing aortic valve replacement are randomized to receive TENS (transcutaneous electrical nerve stimulation) or sham stimulation at one arm for 30 min under various anesthetic conditions: no anesthesia (preanesthesia), sevoflurane or propofol anesthesia. Cardioprotective effects of TENS are compared through Langendorff rat heart perfusion system using plasma dialysate from patients.

Detailed description: Patients undergoing aortic valve replacement are randomized to one of six groups: preanesthesia-TENS (transcutaneous electrical nerve stimulation), preanesthesia-sham, sevoflurane-TENS, sevoflurane-sham, propofol-TENS, propofol-sham. Patients receive TENS or sham stimulation (without electrical pulse generation) at one arm for 30 min under no anesthesia (preanesthesia) or sevoflurane or propofol anesthesia.

In all patients, blood samples are obtained before and after TENS or sham procedure to make plasma dialysate to perfuse rat hearts subjected to ischemia-reperfusion injury through Langendorff system.

Cardioprotective effects are determined by comparing infarct sizes of rat hearts perfused with human plasma dialysate, which reflects cardioprotective effects of TENS in human subjects. By comparing infarct size differences, the myocardial protective effects of TENS in various anesthetic conditions can be determined in human subjects undergoing aortic valve replacement.

Eligibility criteria: Inclusion Criteria:

* patients undergoing aortic valve replacement

Exclusion Criteria:

* co-medications: metformin, nitroglycerine, nicorandil
* discomfort at TENS or loss of intact skin
* uncontrolled hypertension or diabetes mellitus
* severely impaired renal or hepatic function
* peripheral vasculopathy or neuropathy
* did not consent to participate
* pregnancy

Primary outcomes:
measure: Infarct size after TENS
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Yunseok Jeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YJ, Jung DE, Nam K, Bae J, Lee S, Jeon Y. Effects of transcutaneous electrical nerve stimulation on myocardial protection in patients undergoing aortic valve replacement: a randomized clinical trial. BMC Anesthesiol. 2022 Mar 9;22(1):68. doi: 10.1186/s12871-022-01611-x.
Clinical trial NCT01142115: Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Official title: Comparative Study of Two Different Urine Catheters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.

Detailed description: Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Male
* signed informed Consent,
* Neg. urine multistix

Exclusion Criteria:

* Abnormalities,
* diseases or surgical procedures performed in the lower urinary-tract

Primary outcomes:
measure: Discomfort Measured on the Visual Analog Scale (VAS)
timeFrame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Secondary outcomes:
measure: Irritation During Voiding After Catheterization
timeFrame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
measure: Ease of Use Measured on a 5 Point Scale: Insertion Effort
timeFrame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
measure: Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
timeFrame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
measure: Visible Blood
timeFrame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
measure: Haematuria
timeFrame: 2 hours after catheterisation at visits 1 and 2
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, dep. 2112
Study officials:
affiliation: Coloplast A/S
name: Rikke Otttesen, CTM
role: STUDY_DIRECTOR
References: