louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03976232: Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
Official title: Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Chronic Low-back Pain
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Sleep problems in patients with CLBP are a very common complication and is the most neglected part of the management. Though previous literature suggested that sleep problems need to be managed in patients with CLBP, no physical therapy or manual therapy techniques has been checked for their efficacy to manage the same. Therefore, there is a need to check the efficacy of various physical therapy and manual therapy techniques so that sleep problems associated with CLBP can be managed effectively by physical means. The main purpose of the study is to check the efficacy of tDCS and CST to improve sleep, pain and quality of life in patients with CLBP.


Eligibility criteria: Inclusion Criteria:

1. People with chronic low back pain (more than 3 months)
2. Both males and females.
3. 18-50 years
4. Able to follow verbal commands.

Exclusion Criteria:

1. Diagnosed with primary sleep disorders
2. Pregnancy
3. Taking any medication for a psychological disorder
4. Acute or subacute LBP
5. Diagnosed with any other systemic disorder.
6. Spinal tumour.
7. Radicular pain and nerve root compression.
8. Severe spinal stenosis, spondylolisthesis, fibromyalgia.
9. Unstable angina and other cardiovascular disorders.
10. Malignancy.
11. History of other systemic and inflammatory disease.

Primary outcomes:
measure: Polysomnography
timeFrame: changes between baseline to 2 weeks and 6 weeks
measure: Pittsburgh sleep quality Index scale.
timeFrame: changes between baseline to 2 weeks and 6 weeks
Secondary outcomes:
measure: Modified Oswestry disability index
timeFrame: changes between baseline to 2 weeks and 6 weeks
measure: NPRS
timeFrame: changes between baseline to 2 weeks and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05914532: New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI
Official title: In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Keywords: Axial Spondyloarthritis
Systemic Immune Inflammation Index
Systemic Inflammation Response Index
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1:healthy controls working in our hospital,

Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria

Brief summary: investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).

Detailed description: The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count\*monocyte count/lymphocyte count and SII= neutrophil count\*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.

Eligibility criteria: Inclusion Criteria:

* SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
* 51 healthy controls working in our hospital,

Exclusion Criteria:

infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women

Primary outcomes:
measure: Comparison of SIRI and SII between Patient and Healthy Control
timeFrame: Baseline
Secondary outcomes:
measure: Correlation analysis of SIRI and SII with scales and laboratory findings
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Resarch Hospital
Study officials:
affiliation: İstanbul Training and Research Hospital
name: Burak Tayyip DEDE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.
Clinical trial NCT05394532: Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
Official title: Effect of Steno Diabetes Dialogue Cards Teaching Instrument on Diabetes in Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
HbA1c
Self-management
Keywords: type 1 diabetes mellitus
Steno Balance Card
group health education
blood sugar control
self-management
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 83
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled.


Eligibility criteria: Inclusion Criteria:

* 10-18years ord Type 1 DM.
* Able to read and write Chinese.

Exclusion Criteria:

* Communication and cognitive impairments.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: self management
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Fangyi Lin
state: Beitou
Study officials:
References:
Clinical trial NCT04522232: Laparoscopic Hysterectomy With Prior Uterine Artery Ligation
Official title: Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Artery Injury
Hysterectomy
Keywords: Hysterectomy
Laparoscopy
Uterine Artery Ligation
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Helwan University
name: Cairo University
name: Al-Azhar University
First posted: 2020-08-21
Enrollment: 127
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Both grouped were compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up.


Eligibility criteria: Inclusion Criteria: any benign uterine pathology such as:

* fibroid uterus
* endometrial hyperplasia with failed hormonal therapy
* DUB with failed medical and hormonal treatment
* uterine prolapse.

Exclusion Criteria:

* gynecologic malignancy
* presence of contraindications to laparoscopy.

Primary outcomes:
measure: blood loss
timeFrame: during the Laparoscopy
measure: operation time
timeFrame: during the Laparoscopy
Secondary outcomes:
measure: intraoperative or postoperative complications
timeFrame: during the Laparoscopy and during the hospital stay (24 hours postoperative)
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar university hospital (new Damietta)
Study officials:
affiliation: National Research Centre, Egypt
name: Mazen Abdel-Rasheed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722732: Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma
Official title: Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periampullary Carcinoma
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-29
Enrollment: 36
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: the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial

Detailed description: the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.

Eligibility criteria: Inclusion Criteria:

1. Patients of both the sex aged between \>18 years.
2. Patients with a diagnosis of resectable periampullary carcinoma on imaging.
3. Patients with ASA grade 1 or 2

Exclusion Criteria:

* 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above

Primary outcomes:
measure: intraoperative blood loss in ml, quantitative
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: G B Pant Hospital
state: Delhi
Study officials:
affiliation: GBPant Hospital
name: H H Nag, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02343432: Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
Official title: Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Anesthesia
Adverse Effect
Spinal
Epidural
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
Collaborators: name: University of Gaziantep
First posted: 2015-01-22
Enrollment: 75
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study was aimed to investigate the impact of using different epidural volumes.

Patients with acute discogenic pain were included in the study.

Detailed description: Objectives: This study was aimed to investigate the impact of using different epidural volumes.

Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone \[80 mg\] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) \[O= no pain, 10 = unbearable pain\], SLET(straight leg elevation test) \[0° = worst, 85° = best\], and Oswestry Disability Index; ODI \[0% to 20%:minimal disability , 80% to 100%:bed bound patients\] before and 2 weeks after the EPSI.

Eligibility criteria: Inclusion Criteria:

* acute discogenic pain with less than three months duration not responding to other modalities of conservative management \[NSAIDs, physiotherapy, bracing, etc.\],
* radiological disc bulging accompanying unilateral root impingement symptoms,
* an Oswestry daily activity score more than 20 percent, and
* resistance to treatment.

Exclusion Criteria:

* Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.

Primary outcomes:
measure: VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
timeFrame: 2 weeks
measure: SLET(straight leg elevation test) [0° = worst, 85° = best]
timeFrame: 2 weeks
measure: Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Gaziantep
name: Lütfiye Budak
role: STUDY_DIRECTOR
References:
citation: Runu R, Sinha NK, Pai R, Shankar PR, Vijayabhaskar P. Our experience with epidural steroid injections in management of low backpain and sciatica. Kathmandu Univ Med J (KUMJ). 2005 Oct-Dec;3(4):349-54.
Clinical trial NCT05570032: Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients
Official title: Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: NCS University System
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single group quasi-experimental study was conducted at Rafsan Neuro Rehab Center, Peshawar from October 2021 to February 2022. The sample size of study was 40 post stroke patients who were diagnosed on physical findings and other investigation like CT and MRI. The inclusion criteria were set as post-stroke patients for more than 3 months with 20 and above score on MAS scale and age of 55 to 65 years, while the exclusion criteria were defined as participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia, patients having recurrent episodes of stroke, stroke patient with dementia and score on MAS scale below 20.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were set as post-stroke patients for more than 3 months
* 20 and above score on MAS scale
* age of 55 to 65 years

Exclusion Criteria:

* The exclusion criteria were defined as
* participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia,
* patients having recurrent episodes of stroke,
* stroke patient with dementia
* score on MAS scale below 20.

Primary outcomes:
measure: TUG test
timeFrame: 8 weeks
measure: MAS scale
timeFrame: 8 weeks
measure: Forward stepping test
timeFrame: 8 weeks
measure: Functional reach test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hazrat Bilal
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Medical University Peshawar
name: Shakir Ullah, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449732: Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Official title: Evaluation of the Pupil Dilation Reflex (PDR) Using a Pupillary Pain Index (PPI) Stimulation Protocol in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Monitoring, Intraoperative
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.

Detailed description: An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients from the age of 28 days till 18 years undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.

Eligibility criteria: Inclusion Criteria:

* Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
* ASA I-II

Exclusion Criteria:

* History of eye deformity, invasive ophthalmologic surgery
* Known cranial nerve(s) deficit
* Infection of the eye
* Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society)
* Chronic opioid use (\>3 months)
* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
* Preoperatively administrated benzodiazepins or antiemetics

Primary outcomes:
measure: Stimulation Intensity
timeFrame: During pupil measurements in the perioperative period
Secondary outcomes:
measure: Pupillary Pain Index score
timeFrame: During pupil measurements in the perioperative period
measure: Blood pressure
timeFrame: During PDR measurements
measure: Heart rate
timeFrame: During PDR measurements
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Nathalie Kegels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Vera Saldien, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02899832: A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms
Official title: A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: children
spasms
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 3 and 6 years old presenting infantile spasms

Brief summary: This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians


Eligibility criteria: Inclusion Criteria:

* Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

Exclusion Criteria:

* Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

Primary outcomes:
measure: changes in HbO
timeFrame: Day 0
measure: changes in Hbr
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Paris
country: France
facility: Fondation Ophtalmologique Rothshild
Study officials:
affiliation: CHU Amiens
name: Fabrice WALLOIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: