louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02346643: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region
Official title: BINGO: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Pain Patients

Brief summary: 11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has participated in another clinical investigation within 30 days
9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
10. Subject has been diagnosed with cancer in the past 2 years.

Primary outcomes:
measure: Pain Intensity in Primary Region of Pain
timeFrame: Post treatment at 3, 6 and 12 months
measure: Pain Intensity in Overall Pain
timeFrame: Post treatment at 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska sjukhuest
Study officials:
References:
Clinical trial NCT06093243: Women's Knowledge About Endometriosis
Official title: Women's Knowledge About Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Keywords: Women
knowledge
endometriosis
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of childbearing age with or without endometriosis

Brief summary: In the world, 10% of women of childbearing age have endometriosis with diagnostic mostly between 25 and 30 years old.

Endometriosis is the leading cause of infertility in our country. A diagnosis delay of approximately 6.7 years is observed for endometriosis.

Detailed description: The aim of the study will be to describe knowledge of women about endometriosis.

Eligibility criteria: Inclusion Criteria:

* women older than 18
* women of childbearing age
* with or without gynecological history
* agreed to participate in the study

Exclusion Criteria:

None

Primary outcomes:
measure: knowledge score on endometriosis symptoms
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
References:
Clinical trial NCT06401343: Use of SGLT2i in noHCM With HFpEF
Official title: Sodium-dependent Glucose Transporters 2 Inhibitor in Nonobstructive Hypertrophic Cardiomyoapthy Patients With Heart Failure With Preserved Ejection Fraction: a Prospective, Multi-center,Open-lable,Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertrophic Cardiomyopathy
Heart Failure With Preserved Ejection Fraction
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-05-06
Enrollment: 94
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 study aims to evaluate the impact of Sodium-dependent glucose transporters 2 inhibitor Empagliflozin on the exercise capacity,symptoms of heart failure, cardiac function, myocardial remodeling and quality of life of nonobstructive HCM patients with HFpEF.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of nonobstructive hypertrophic cardiomyopathy;
* At least 18 years old;
* LVEF≥50%
* Elevated NT-proBNP \>300 pg/ml for patients without atrial fibrillation (AF), or \>900 pg/ml for patients with AF at Visit 1;
* NYHA II-IV
* Capable of performing cardiopulmonary exercise test with an RER≥1.0
* Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion Criteria:

* Under-went septal reduction therapy within 3 months before screening;
* Acute decompensation heart failure within 3 months before screening;
* Symptomatic low BP or SBP\<100mmHg;
* eGFR\<30ml/min/1.73m2
* LVOTG ≥30mmHg at rest or under provocation;
* Renal insufficiency with eGFR\<50mL/min/1.73m2
* ICD implantation or CRT planned within 3 months;
* Women who are pregnant, or who plan to become pregnant while in the trial;
* Currently enrolled in another investigational device or drug trial;
* Combining any other clinical condition with a life expectancy less than 1 year.

Primary outcomes:
measure: VO2max on cardiopulmonary exercise tesing
timeFrame: 12 months
Secondary outcomes:
measure: NT-ProBNP
timeFrame: 12 months
measure: NYHA heart failure classification
timeFrame: 12 months
measure: KCCQ-CSS
timeFrame: 12 months
measure: HCMSQ-(SoB)
timeFrame: 12 months
measure: E/A
timeFrame: 12 months
measure: E/e'
timeFrame: 12 months
measure: Peak tricuspid regurgitation velocity
timeFrame: 12 months
measure: Left atrium volume index , LAVI
timeFrame: 12 months
measure: Left Ventricular Mass index, LVMI
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT03497143: Bariatric Surgery and Pharmacokinetics of Lamotrigine
Official title: Bariatric Surgery and Pharmacokinetics Lamotrigine: BAR-MEDS Lamotrigine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Lamotrigine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lamotrigine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Lamotrigine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01930643: Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
Official title: Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Respiratory Failure
Critical Illness Myopathy
Keywords: Electric muscle stimulation
mechanical ventilation
chronic respiratory failure
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.

Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.

Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.

Detailed description: Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).

EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).

Eligibility criteria: Inclusion Criteria:

* Adult patient required mechanical ventilation more than 14 days
* No ability for active endurance exercise because of poor consciousness or limb weakness.

Exclusion Criteria:

* Pregnant women
* Limb wound/infection interfered with electric pad application
* Recent acute myocardial infarction or life-threatening arrhythmia
* Uncontrolled epilepsy
* Dying patients without attempt of ventilator weaning
* Absence of respiratory drive

Primary outcomes:
measure: Ventilator-free Days
timeFrame: 28 days
Secondary outcomes:
measure: Grip Power
timeFrame: 7 days after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Kuang H Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872143: Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Official title: Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mental Disorders
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated

Detailed description: Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

Eligibility criteria: Inclusion Criteria:

* a psychiatric disorder in which available treatment are either ineffective or not tolerated

Exclusion Criteria:

* implantable active devices

Primary outcomes:
measure: Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits
timeFrame: Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: AOU "Federico II" of Naples
Study officials:
affiliation: AOU "Federico II" of Naples
name: giordano d'urso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626143: Effect of Feeding Mode on Infant Growth and Cognitive Function
Official title: Effect of Feeding Mode on Infant Growth and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Nutricion y Tecnologia de los Alimentos (INTA)
First posted: 2015-12-10
Enrollment: 582
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.


Eligibility criteria: Inclusion Criteria:

* Singleton, 0-120 days of age at study entry
* Term infant with birth weight of 2500 to 4500 grams
* Exclusively feed infant formula or exclusively feeding breast milk
* Signed informed consent

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
* Feeding difficulties or formula intolerance
* Receiving complementary feedings

Primary outcomes:
measure: Body weight
timeFrame: 24 months
measure: Auditory Event-related Potential
timeFrame: 24 months
measure: Body length
timeFrame: 24 months
measure: Head circumference
timeFrame: 24 months
Secondary outcomes:
measure: Dietary Intake
timeFrame: 24 months
measure: Medically confirmed adverse events
timeFrame: 24 months
measure: Body Composition: Air Displacement Plethysmography
timeFrame: 6 months
measure: Body Composition: Deuterium Dilution
timeFrame: 12 and 24 months
measure: Blood sample: Micronutrient status
timeFrame: 24 months
measure: Blood sample: Metabolic markers
timeFrame: 24 months
measure: Bayley Scales of Infant and Toddler Development
timeFrame: 12 months
measure: Sleep measures (Amount of time awake & asleep in a 7-day period)
timeFrame: 24 months
measure: Language development: Native3 Phoneme Repertory
timeFrame: 12 months
measure: Language development: Word Discovery
timeFrame: 10 months
measure: Language development: Rule Inference
timeFrame: 10 months
measure: Language development: MacArthur Communicative Development Inventory
timeFrame: 24 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto de Nutricion y Tecnologia de los Alimentos
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, MD
role: STUDY_DIRECTOR
References:
citation: Toro-Campos R, Algarin C, Peirano P, Pena M, Murguia-Peniche T, Wu SS, Uauy R. Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT). BMC Pediatr. 2020 May 18;20(1):225. doi: 10.1186/s12887-020-02087-9.
Clinical trial NCT01686243: Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Placement
Keywords: epidural
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"

The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound.

Measurable outcomes:

* Block performance time.
* Block success rate.
* Needle Depth to epidural space

Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia.

All cases that will be converted to general anesthesia will be counted unsuccessful.

Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina


Eligibility criteria: Inclusion Criteria:

* Adult Patients 30 to 80 years old at time of surgery.
* Patients in whom epidural anesthesia is planned to be used as the for surgery " Surgical epidural"

Exclusion Criteria:

* Current or recent drug abuse (within past 6 months).
* Allergy to local anesthetics
* Patient refusal.

Primary outcomes:
measure: Real-time ultrasound-guided paramedian epidural access:
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sherif Zaky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsharkawy H, Saasouh W, Babazade R, Soliman LM, Horn JL, Zaky S. Real-time Ultrasound-Guided Lumbar Epidural with Transverse Interlaminar View: Evaluation of an In-Plane Technique. Pain Med. 2019 Sep 1;20(9):1750-1755. doi: 10.1093/pm/pnz026.
Clinical trial NCT01655238: Obesity Guidelines for Outpatient Surgery
Official title: Have NCH Obesity Guidelines Made an Impact? Differences in Anesthetizing the Obese Child in Outpatient Sites Versus Main OR at NCH.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 1327
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients

Brief summary: The investigators are concerned about anesthetizing obese children in outpatient locations in case they need prolonged stay, increased respiratory interventions, or need for post-operative narcotics. The investigators will be using a screening guideline to help us determine the higher risk child based on BMI and co-morbid conditions. The investigators will also be doing a retrospective chart review of 300 patients with BMI 95% and looking at various factors during the operative and post-operative period.


Eligibility criteria: Inclusion Criteria:

* Patients 95% or over BMI having outpatient surgery.

Primary outcomes:
measure: Length of stay
timeFrame: 1 week
Secondary outcomes:
measure: Number of subjects with respiratory complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Vidya Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith HL, Meldrum DJ, Brennan LJ. Childhood obesity: a challenge for the anaesthetist? Paediatr Anaesth. 2002 Nov;12(9):750-61. doi: 10.1046/j.1460-9592.2002.00781.x.
citation: Nafiu OO, Reynolds PI, Bamgbade OA, Tremper KK, Welch K, Kasa-Vubu JZ. Childhood body mass index and perioperative complications. Paediatr Anaesth. 2007 May;17(5):426-30. doi: 10.1111/j.1460-9592.2006.02140.x.
Clinical trial NCT05812638: Mental Imagery for Lower Limb Functions
Official title: Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. The poor motor performance of lower limb affects gait severely. The slow velocity and other gait deviations limit the stroke survivors' ability to perform ADL's and interfere with their quality of life.

Hence, rehabilitation is obligatory for these patients to improve their quality of life

Detailed description: motor imagery is helpful in improving mobility in healthy and neurologically impaired patients. When the patient is asked to do a movement, for example the patient is asked to walk along a draw line and then that patient has to imagine this same action in kinesthetic imagery. Neuroimaging shows that brain areas are more or less activated in the same manner. It can be concluded that there is some relation between mental imagery ability and muscular actions. In the stroke patients who have intact ability of mental imagery show activation of cortical areas demonstrating its ability to activate sub cortical areas also. Therefore, these results amplify the concept of using mental imagery for rehabilitation purpose of even deep lesion in motor nervous system.

Eligibility criteria: Inclusion Criteria:

* Stroke patients (both genders)
* Age 40-60 years
* Patients with sub-acute/ chronic stroke (\>3 months)
* Modified Ashworth Ranking Scale 1-3
* MOCA scoring \>24-30

Exclusion Criteria:

* Any active pathological condition
* Visual or hearing impairment
* Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative
* Joint Diseases etc.)
* Psychological issues

Primary outcomes:
measure: Fugl Meyer Assessment Scale - Lower Extremity
timeFrame: week 6
measure: Berg Balance Scale
timeFrame: week 6
measure: Timed Up and Go test
timeFrame: week 6
measure: 10-meter walk test
timeFrame: week 6
measure: Wisconsin Gait Scale
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
Study officials:
affiliation: Riphah International University
name: arshad Malik, Phd
role: PRINCIPAL_INVESTIGATOR
References: