louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03634722: The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.
Official title: Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: transcutaneous electrical nerve stimulation;
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 126
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Primary purpose: PREVENTION

Brief summary: The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.

Detailed description: All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.

Eligibility criteria: Inclusion Criteria:

* severe pelvic organ prolapse(POP-Q:3/4 stage)
* accept pelvic reconstructive surgery

Exclusion Criteria:

* Dominant stress urinary incontinence
* Serious medical problems
* mental disease
* infectious disease

Primary outcomes:
measure: the rate of urinary retention
timeFrame: three days after surgery
Secondary outcomes:
measure: the rate of urinary incontinence
timeFrame: three days; seven days; one month; three months; six months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Beijing Key Laboratory of Female Pelvic Floor Disorders
name: Xiuli Sun
role: STUDY_CHAIR
References:
Clinical trial NCT05795322: Acute Effect of Sound Healing on Pain, Fatigue and Mood
Official title: Acute Effect of Sound Healing on Pain, Fatigue and Mood: A Retrospective Community Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Fatigue
Mood Change
Keywords: Sound healing with tuning forks
Lead sponsor: Innowage Limited
Sponsor class: INDUSTRY
Collaborators: name: Aarogyam UK
name: Suara Sound Academy
First posted: 2023-04-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged between 18-85, having long term illnesses for more than 6-month, completed 30-mins selected sound healing track with tuning forks virtually and shared their impact post session, were evaluated retrospectively.

Brief summary: There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.


Eligibility criteria: Inclusion Criteria:

* People with long term illnesses who attended 'Tuning for Health' virtual session

Exclusion Criteria:

* Who did not complete 30-mins Sound Healing

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: From baseline to 30-minutes post intervention
measure: Change in Fatigue
timeFrame: From baseline to 30-minutes post intervention
measure: Change in Mood
timeFrame: From baseline to 30-minutes post intervention
Secondary outcomes:
measure: Patients Satisfaction
timeFrame: From baseline to 30-minutes post intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam UK CIC
Study officials:
affiliation: Suara Sound Academy
name: Debbi Walker
role: STUDY_DIRECTOR
affiliation: Aarogyam UK CIC
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03867422: Changes in Brain Tissue Pulsatility With Musical Stimuli
Official title: Changes in Brain Tissue Pulsatility With Musical Stimuli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility Imaging (TPI) in a music task. The use of TPI to measure reactivity of Brain Tissue Pulsatility Imaging (BTP) could further elucidate the cerebral basis of music perception.


Eligibility criteria: Inclusion Criteria:

* more or equal 18 years-old and less or equal 45 years-old
* no known hearing problem

Exclusion Criteria:

* professional musician
* history of neurologic, psychiatric or cadiologic disease
* treatment which could impact parameters of brain tissue pulsatility and peripheral nervous system
* opposition to use the data

Primary outcomes:
measure: amplitude of variations in brain tissue pulsatility
timeFrame: Baseline
Secondary outcomes:
measure: heart rate
timeFrame: Baseline
measure: breathing rate
timeFrame: Baseline
measure: skin conductance
timeFrame: Baseline
measure: score of barcelona music reward questionnary (BMQR)
timeFrame: Baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: DESMIDT
Study officials:
References:
Clinical trial NCT05609422: Scooter Board Activities in Diplegic Cerebral Palsy
Official title: Effect of Scooter Board Activities on Trunk Postural Control and Gait in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegia
Keywords: diplegia
cerebral palsy
core stability
trunk control
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The selected subjects will be divided into two groups of equal numbers (control and study).
Primary purpose: TREATMENT

Brief summary: Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.

Detailed description: Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child. A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.

Eligibility criteria: Inclusion Criteria:

1. CP with a diplegia
2. Age 7 to 11 years
3. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
4. They could walk with limitation or holding on according to GMFCS (level I\&II \&III) (Palisano et al., 1997).
5. They were able to understand and follow verbal instructions

Exclusion Criteria:

1. Children with any surgical interference in the upper limb.
2. intellectual disability such that simple tasks could not be understood or executed.
3. Children with any visual or auditory problems.
4. Children with any surgical interference in the lower limb.
5. Children with any structural deformities in joints and bones of lower limbs.
6. Children who suffer from other diseases or associated disorders that interfered with physical activity.

Primary outcomes:
measure: Trunk control measurement scale (TCMS)
timeFrame: 3 months
measure: 2D video-based gait assessment system
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Badr University
state: Cairo
Study officials:
affiliation: lecturer
name: Omnya samy, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05359822: Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report
Official title: Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Computed Tomography for Calicum Scoring
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 7000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to examine if communication of image-based cardiovascular risk to patients undergoing coronary artery calcium scoring (CAC) improves patient understanding of their risk for cardiovascular disease when compared with usual care (physician-only report).


Eligibility criteria: Inclusion Criteria:

* Age range: from 40 to 89
* Referred for CAC at UHHS

Exclusion Criteria:

* Less than 40 years of age or over 89 years old.
* Underwent CAC at other locations besides UHHS.

Primary outcomes:
measure: Change in LDL Cholesterol
timeFrame: baseline-12 months
Secondary outcomes:
measure: Change in Total Cholesterol
timeFrame: baseline-12 months
measure: Change in Triglycerides
timeFrame: baseline-12 months
measure: Change in HDL cholesterol
timeFrame: baseline-12 months
measure: Change in Weight
timeFrame: baseline-12 months
measure: Change in Systolic blood pressure
timeFrame: baseline-12 months
measure: Change in Diastolic blood pressure
timeFrame: baseline-12 months
measure: Change in HbA1c
timeFrame: baseline-12 months
measure: Smoking Cessation Visits as measured by medical record review - yes/no
timeFrame: 12 months
measure: Statin prescriptions written as measured by medical record review - yes/no
timeFrame: 12 months
measure: Aspirin prescriptions written as measured by medical record review - yes/no
timeFrame: 12 months
measure: Stress tests ordered as measured by medical record review - yes/no
timeFrame: 12 months
Other outcomes:
measure: Exploratory: Change in Perception of Risk of Heart Diseases as measured by Perception of Heart Disease Risk score
timeFrame: Baseline, 3 months, 12 months
measure: Exploratory: Change in Motivation to Change Behavior as measured by Motivation to Change Behavior (TSRQ) Survey Behavior
timeFrame: Baseline, 3 months, 12 months
measure: Exploratory: Change in Medication adherence as measured by Medication adherence (MARSS) Survey
timeFrame: Baseline, 3 months, 12 months
Locations:
Study officials:
affiliation: University Hospitals
name: Sadeer Al-Kindi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909622: Trial of Vitamin D Fortified Milk
Official title: A Randomized Trial of Milk Fortified With Vitamin D in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 25-hydroxyvitamin D Serum Concentrations
Keywords: Vitamin D
Milk fortification
Children
Colombia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 144
Maximum age (years): 174
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification varies by dose, duration, and population characteristics; and it is currently unknown whether it could be an efficacious public health intervention to curb the VDD epidemic among children living in tropical areas. We propose to conduct a randomized, controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families with a child participating in an ongoing cohort study will be randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to give the index child two cups of milk per day and to distribute the remaining milk to the rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the intervention period.


Eligibility criteria: Inclusion Criteria:

1. Age between 144 and 174 completed months by the time of enrollment.
2. Intention to stay in the city for the next six weeks.
3. Children living with their biological mothers.
4. Families own a refrigerator.

Exclusion Criteria:

1. History of illness involving calcium or bone metabolism, including stones of the urinary tract.
2. Currently taking vitamin D supplements as treatment of any disease.
3. Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year.
4. Known history of lactose intolerance or other contra-indications or aversion to milk intake.
5. Known hypercalcemia.

Primary outcomes:
measure: Serum concentrations of 25-OH vitamin D
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: FINUSAD - Foundation for Research in Nutrition and Health
city: Chia
country: Colombia
facility: University of La Sabana
Study officials:
affiliation: FINUSAD - Foundation for Research in Nutrition and Health
name: Mercedes Mora, MSc, RD
role: STUDY_DIRECTOR
affiliation: University of La Sabana
name: Henry Oliveros, MD, MSc
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Eduardo Villamor, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02973022: A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2
Official title: A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2016-11-25
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty ACEC employees and 30 residents of a rural Wisconsin county. The researchers will work to make sure the sample is representative of the community in regards to age, gender, and employments status.

Brief summary: The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple (CC\&S) educational sessions on cancer prevention and screening. The researchers will recruit 60 community members: 30 will receive CC\&S training (intervention group) and 30 will not (control group). All 60 will be surveyed about their intent to change their behavior at the beginning of the study and their actual behavior changes and their screening behavior 6 months after enrollment in the study.


Eligibility criteria: Inclusion Criteria:

* Wisconsin resident

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in behavioral intent
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Change in cancer knowledge
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Elizabeth Jacobs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03506022: Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes
Official title: Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients over 18 years with type 1 mellitus diabetes will be included. The exclusion criteria are type-free diabetes (type 1 slow), age \<18 years, a poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
Primary purpose: OTHER

Brief summary: Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control.

This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years
* with type 1 mellitus diabetes

Exclusion Criteria:

* Type-free diabetes (type 1 slow),
* Age \<18 years
* A poor compliance with the follow-up (meetings unfulfilled without justification).
* All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).

Primary outcomes:
measure: Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01446822: Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Official title: Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm of Lateral Wall of Urinary Bladder
Keywords: urinary bladder neoplasm
bipolar transurethral resection
monopolar transurethral resection
obturator nerve
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 44
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: This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.

One of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. This is an important safety aspect for the patient.

Main study question: In patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?


Eligibility criteria: Inclusion Criteria:

* neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
* operability given based on general medical condition
* informed consent

Exclusion Criteria:

* antiplatelet drugs stopped \<7days (except acetylsalicylate \<= 100mg p.o. qd)
* prothrombine time \<70%
* age \<18 years
* patronized Patients
* pregnancy
* severe poor medical condition

Primary outcomes:
measure: Successful resection of bladder tumor
timeFrame: Intraoperative
Secondary outcomes:
measure: Complications
timeFrame: 3 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital of St.Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Daniel S Engeler, MD
role: STUDY_CHAIR
References:
citation: Gramann T, Schwab C, Zumstein V, Betschart P, Meier M, Schmid HP, Engeler DS. Transurethral resection of bladder cancer on the lateral bladder wall without obturator nerve block: extent of adductor spasms using the monopolar versus bipolar technique-a prospective randomised study. World J Urol. 2018 Jul;36(7):1085-1091. doi: 10.1007/s00345-018-2248-0. Epub 2018 Mar 1.