louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01852734: Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Official title: Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Arterial Embolization
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective non-randomised study is to examine whether two different microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination.

Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization.

Another purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in OUH analysed retrospectively.

Detailed description: Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres until blood flow stop ( " cut the tree" appearance).

Group 2: 26 patient will be treated with Embosphere; 500-900 µm until "near-stasis" flow stop in the uterine artery.

Clinical and Technical success will be examined, and radiological follow-up 3 and 12 months after embolization using MR contrast-enhanced examination in a Bead Block group and only 3 months control in Embosphere group to assess total fibroid burden infraction degree and eventually residual contracts fibroid enhancement.

Quantitative MRI dominant fibroid characteristic for and 3 months after an intervention to examine eventually potential of as a possible predictor of the volumetric response of the uterine fibroid.

Retrospective study compromised all patient treated between January 2001 until January 2011 with follow up to January 2014, and re-intervention as well as complications rate analysis.

Eligibility criteria: Inclusion Criteria:

* symptomatic uterus fibroma

Exclusion Criteria:

* pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis)
* gravidity
* uterus malignancy
* big subserosal fibroma with stalk diameter of \<2 cm
* menopausal women
* don,t want to be included into the study

  * concomitant adenomyosis

Primary outcomes:
measure: clinical effect
timeFrame: one year
Secondary outcomes:
measure: reinterventions rate
timeFrame: one year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Stevo Duvnjak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05813834: Ultrasound-guided Genicular Nerves Block
Official title: US-guided Genicular Nerves Block for Pain Control After Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Double Blinded, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genicular Nerve Block for Pain in ACL Arthroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Genicular Nerves Block
Primary purpose: TREATMENT

Brief summary: Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.

in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Detailed description: In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Eligibility criteria: Inclusion Criteria:

* both genders
* age 18 - 65
* ASA i, ii, iii

Exclusion Criteria:

* ROM less than 90
* advanced renal or liver diseases
* patient refusal
* substance abuse
* site infection
* known sensitivity to any of study drugs

Primary outcomes:
measure: post operative VAS
timeFrame: 24 hours
Secondary outcomes:
measure: total morphine consumption
timeFrame: 24 hours
measure: time to first morphine analgesia
timeFrame: 24 hours
measure: range of motion
timeFrame: 24 hours
measure: post operative MAP
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: Dalia K Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550834: Wheelchair Indoors Curling With SCI patients_RCT
Official title: The Effects of Indoors Curling Exercise in Persons With Chronic Spinal Cord Injury on Control Capabilities of Trunk Movements: a Randomized-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: Core stability
Indoors curling exercises
Motivation
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: Clinique Romande de Readaptation
name: Uniklinik Balgrist, Zürich
First posted: 2015-09-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an Indoor Curling Exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.

Detailed description: Spinal cord injury (SCI) is a catastrophic event that can be devastating and costly in human and social terms. These patients require multidisciplinary and interdisciplinary treatment. Physiotherapy is important factor in SCI rehabilitation.

The objectives of physiotherapists are manifold and include the development of the force of healthy muscles, the teaching of transfer techniques, the maintenance of joint motion and of the body map, and the reestablishment of sitting balance in order for the patients to regain their autonomy.

Maintaining postural stability when seated is a challenge for people with a SCI as their sensory and motor systems in their trunk, lower and upper extremities have been damaged to different degrees. To train this postural stability, physiotherapists include many interventions. Physical activities in sport therapy are some of them. In addition to usual physical activities (basketball, tennis, wheelchair running,...) the investigators propose to practice wheelchair Indoors Curling Exercise with wooden Curling Stones.

Eligibility criteria: Inclusion Criteria:

* Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia
* Complete spinal cord status (ASIA Score)
* Sitting capabilities ≥ 4 hours
* Capability to bench 20° forward in trunk flexion
* Signed informed consent after being informed

Exclusion Criteria:

* Progressives pathologies
* Problem in vestibular system
* Severely impaired vision
* Tetraplegia without hand function
* Acute pain
* Contraindications on ethical grounds
* Previously reduced capabilities of cooperation
* Know or suspected non-compliance

Primary outcomes:
measure: Sitting balance
timeFrame: 8 weeks
Secondary outcomes:
measure: Intrinsic Motivation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique romande de réadaptation CRR-SUVA
state: Valais
city: Zurich
country: Switzerland
facility: Uniklink Balgrist
Study officials:
References:
Clinical trial NCT04472234: BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility
Official title: Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
IVF
Infertility, Female
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 82
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.


Eligibility criteria: Inclusion Criteria:

* patients aged 23-33 years who underwent IVF due to unexplained infertility
* patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day
* patients who did not smoke or use alcohol
* patients did not work in the plastic industry

Exclusion Criteria:

* patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications
* patients diagnosed with endometriosis
* patients with freeze-all cycles
* women with metabolic disease (such as hypertension or diabetes mellitus)
* patients with a known genetic problem (male or female)

Primary outcomes:
measure: Exposure to BPA
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sanlıurfa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT01482234: Text Messages and Physical Activity Among Teens
Official title: TXT Me: Texting Motivational Messages Encouraging Adolescent Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
exercise
walking
pedometers
goal setting
text messages
motivation
intrinsic motivation
extrinsic motivation
self determination theory
prompts
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-11-30
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether text messages can be used as a way to increase the amount of physical activity teens get each day.

Detailed description: This research will develop an innovative intervention that promotes physical activity to 14-17 year olds (roughly high school aged youth). It is guided by Self Determination Theory and seeks to enhance adolescents' feelings of physical activity autonomy, competence, and relatedness, key psychological needs related to motivation to be physically active. The physical activity to be promoted is walking, which has broad appeal and can be performed as part of usual-day activities. Since youth are heavy users of cell phones and texting, the intervention will send theoretically-grounded text messages designed to enhance physical activity.

Eligibility criteria: Inclusion Criteria:

* 14-17 years old
* access to a computer with high speed internet access
* home email address
* cell phone that can send/receive text messages
* text message plan
* fluent in English

Exclusion Criteria:

* mental or physical limitations that impair ability to fully participate in the program and/or complete baseline and post assessment data collection.

Primary outcomes:
measure: physical activity
timeFrame: 3 months
Secondary outcomes:
measure: Psychological need satisfaction in exercise
timeFrame: 3 months
measure: Behavioral Regulation in Exercise
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Deborah Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson D, Cantu D, Ramirez B, Cullen KW, Baranowski T, Mendoza J, Anderson B, Jago R, Rodgers W, Liu Y. Texting to Increase Adolescent Physical Activity: Feasibility Assessment. Am J Health Behav. 2016 Jul;40(4):472-83. doi: 10.5993/AJHB.40.4.9.
citation: Thompson D, Cantu D, Bhatt R, Baranowski T, Rodgers W, Jago R, Anderson B, Liu Y, Mendoza JA, Tapia R, Buday R. Texting to Increase Physical Activity Among Teenagers (TXT Me!): Rationale, Design, and Methods Proposal. JMIR Res Protoc. 2014 Mar 12;3(1):e14. doi: 10.2196/resprot.3074.
Clinical trial NCT04935034: Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
Official title: Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The is a 4 arm single-blinded crossover study
Primary purpose: PREVENTION

Brief summary: The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms:

i) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink

Detailed description: This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours.

On the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast.

1. mixed micelles
2. olive oil
3. fish oil
4. fat-free

Participants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit.

Eligibility criteria: Inclusion Criteria:

Healthy men and women

Exclusion Criteria:

Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.

An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.

Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months

Primary outcomes:
measure: Change in 25-hydroxyvitamin D (25(OH)D)
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
References:
Clinical trial NCT06306534: Auditory Intranerve Stimulation Study
Official title: Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Auditory; Nerve
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
3. Age ≥ 18 years
4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion Criteria:

1. Disabilities in addition to hearing impairment which might interfere with the study procedure
2. Pregnant and breast feeding woman or other vulnerable population

Primary outcomes:
measure: Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
timeFrame: 4 weeks
Secondary outcomes:
measure: Collection of adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School, Director of otorhinolaryngology
name: Thomas Lenarz, Prof. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04251234: Light at Night Study
Official title: Light at Night Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Light Sensitivity
Keywords: Circadian
Light Intensity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.

Detailed description: The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.

Eligibility criteria: Inclusion Criteria:

* BMI 18-30 kg/m2
* Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary
* Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center
* Willing and able to maintain stable sleep schedule during study.
* Participants will be breathalyzed and undergo urine drugs screens at every lab visit
* Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs

Exclusion Criteria:

* Color blindness

Primary outcomes:
measure: Melatonin levels
timeFrame: Up to approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Helen Burgess, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00980434: S-100B and Neuron-specific Enolase (NSE) in Spinal Trauma
Official title: The Clinical Use of S-100B and NSE in Spinal Cord Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: vertebral fracture
spinal cord injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from daily practice

Brief summary: The investigators are studying the clinical worth of the serum markers S-100B and NSE in patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury.


Eligibility criteria: Inclusion Criteria:

* vertebral fracture
* injuries to the vertebral spine

Exclusion Criteria:

* head trauma
* polytrauma

Primary outcomes:
measure: Neurological Symptoms
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Head of Department
name: Vilmos Vecsei, M.D. Professor
role: STUDY_CHAIR
References:
citation: Loy DN, Kim JH, Xie M, Schmidt RE, Trinkaus K, Song SK. Diffusion tensor imaging predicts hyperacute spinal cord injury severity. J Neurotrauma. 2007 Jun;24(6):979-90. doi: 10.1089/neu.2006.0253.
citation: Marquardt G, Setzer M, Seifert V. Serum biomarkers for experimental acute spinal cord injury: rapid elevation of neuron-specific enolase and S-100 beta. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207967.91316.8D. No abstract available.
citation: Marquardt G, Setzer M, Seifert V. Protein S-100b for individual prediction of functional outcome in spinal epidural empyema. Spine (Phila Pa 1976). 2004 Jan 1;29(1):59-62. doi: 10.1097/01.BRS.0000103661.78939.02.
citation: Marquardt G, Setzer M, Seifert V. Protein S-100b as serum marker for prediction of functional outcome in metastatic spinal cord compression. Acta Neurochir (Wien). 2004 May;146(5):449-52. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.