louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05164146: The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
Official title: The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Neurosurgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.


Eligibility criteria: Inclusion Criteria:

1. hypertension
2. patients undergoing neurosurgery
3. ASA I-III
4. 19-75 year-old patients

Exclusion Criteria:

1. emergency
2. Patients admitted on the day of surgery
3. cardiac disease
4. liver failure or liver cirrhosis
5. increased intracranial pressure(IICP)
6. mental change
7. Foreigner
8. iliteracy

Primary outcomes:
measure: incidence of hypotension events
timeFrame: procedure (during induction before the surgery)
Secondary outcomes:
measure: blood pressure
timeFrame: procedure (during induction before the surgery)
measure: heart rate
timeFrame: procedure (during induction before the surgery)
measure: sedline psi
timeFrame: procedure (during induction before the surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sujung Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06332846: Oral Health in Patients Hospitalized Because of Ischemic Stroke
Official title: Assessment of Oral Health in Patients Hospitalized Because of Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Disease
Stroke, Ischemic
Keywords: stroke
oral health
dentition
periodontium
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 118
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consisted of 59 individuals subjects with a first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale (NIHSS)). The control group (59 individuals) matched for age and gender was selected among patients of the Department of Interdisciplinary Dentistry at Pomeranian Medical University in Szczecin.

Brief summary: Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.

The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI).


Eligibility criteria: Inclusion Criteria:

* first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale (NIHSS))

Exclusion Criteria:

* aphasia, disturbances of consciousness, mental disorders- making it impossible to express informed consent,
* surgery of the salivary glands- disrupting the secretion of saliva,
* diseases that disrupt salivary secretion (diabetes mellitus, Sjogren's syndrome, condition after radio-therapy in the area of the salivary glands)

Primary outcomes:
measure: Oral health status
timeFrame: Baseline
measure: Oral hygiene assessment
timeFrame: Baseline
measure: Periodontal status- periodontal pockets
timeFrame: Baseline
measure: Periodontal status-tooth mobility
timeFrame: Baseline
measure: Periodontal status- bleeding
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University in Szczecin
Study officials:
References:
Clinical trial NCT05551546: Functional Medicine Health Coaching
Official title: Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Lead sponsor: The Institute for Functional Medicine
Sponsor class: OTHER
Collaborators: name: Functional Medicine Coaching Academy
First posted: 2022-09-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this research is to evaluate the feasibility and self-reported health outcomes of functional medicine health coaching in elimination diets among clinicians receiving training in functional medicine.

A randomized controlled clinical trial of a 5-session functional medicine coaching and elimination diet intervention will be conducted to achieve the purpose of this study. The research team hypothesizes that functional medicine health coaching to support the elimination diet will improve physical and mental health outcomes better than the control condition of a self-guided elimination diet.


Eligibility criteria: Inclusion Criteria:

* Agree to adopt the elimination diet as outlined by study sponsor with no pre-planned interruption
* Able to understand and write English
* Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

* Eating disorders within the past 10 years
* Currently pregnant or breastfeeding
* Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants

Primary outcomes:
measure: Change from baseline PROMIS-Global Health score
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
measure: Change from baseline Medical Symptoms Questionnaire (MSQ) score
timeFrame: Change from baseline at 10 weeks
measure: Adherence/compliance to the elimination diet
timeFrame: At 10 weeks
Other outcomes:
Locations:
city: Federal Way
country: United States
facility: The Institute for Functional Medicine
state: Washington
Study officials:
affiliation: Functional Medicine Coaching Academy
name: Sandra Scheinbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681746: Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280
Official title: An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 After Oral Administration to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Keywords: Anxiety
GABA receptors
Positron Emission Tomography
PET
phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is carried out in order to determine the relationship between the dose of AZD6280 and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to GABAA receptors


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
* Clinically normal physical findings, medical history and laboratory values.

Exclusion Criteria:

* Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
* History of clinically significant heart arrythmias or heart disease/problems.
* Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.

Primary outcomes:
measure: Positron emission tomography using the radioligand (11C) flumazenil
timeFrame: 4 times per subject
Secondary outcomes:
measure: To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, psychometric tests and laboratory variables.
timeFrame: 6 visits with tests for the 2 subjects in the first group (Panel 1). 4 visits with tests for the 6 remaining subjects. Some tests will be done several times per visit. All tests will not be done at every visit.
measure: Investigate the pharmacokinetics of AZD6280 following single doses of AZD6280 by assessment of drug concentration in plasma.
timeFrame: 3 times for the 2 subjects in the first group (Panel 1). Once for the 6 remaining subjects. Up to 48 hours at each time.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Bo Fransson
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
name: Eva Taavo
role: STUDY_DIRECTOR
References:
citation: Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.
Clinical trial NCT03168646: Arthroscopic Wafer and Ulnar Shortening in Ulnar Abutment
Official title: Comparative Study Between Arthroscopic Wafer and Ulnar Shortening Osteotomy in Ulnar Abutment Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrist Impaction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.


Eligibility criteria: Inclusion Criteria:

* obvious ulnar abutment syndrome with ulnar side wrist pain

Exclusion Criteria:

* ulnar minus or neutral variance
* central and radial wrist pain
* osteoarthritis of the wrist.

Primary outcomes:
measure: mayo scoring system
timeFrame: 6 month
measure: mayo scoring system
timeFrame: 6 month
measure: mayo scoring system
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stockton DJ, Pelletier ME, Pike JM. Operative treatment of ulnar impaction syndrome: a systematic review. J Hand Surg Eur Vol. 2015 Jun;40(5):470-6. doi: 10.1177/1753193414541749. Epub 2014 Jul 30.
citation: Kaufman D, Etcheson J, Yao J. Microfracture for Ulnar Impaction Syndrome: Surgical Technique and Outcomes with Minimum 2-Year Follow-up. J Wrist Surg. 2017 Feb;6(1):60-64. doi: 10.1055/s-0036-1586496. Epub 2016 Aug 5.
citation: Colantoni J, Chadderdon C, Gaston RG. Arthroscopic wafer procedure for ulnar impaction syndrome. Arthrosc Tech. 2014 Jan 24;3(1):e123-5. doi: 10.1016/j.eats.2013.09.008. eCollection 2014 Feb.
Clinical trial NCT06565546: CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
Official title: Feasibility and Efficacy of CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs: A Pilot Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.


Eligibility criteria: Inclusion Criteria:

* \> 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.

Exclusion Criteria:

* ventral hernia \<1.5 cm
* primary ventral hernia repair (VHR) without a mesh
* emergency operative procedure
* receiving chronic opioid therapy (defined as use of opioids on most days for \>3 months)
* allergy to opioids
* women of childbearing potential who have a positive pregnancy result as part of their standard pre-surgical workup

Primary outcomes:
measure: Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care.
timeFrame: 6 months
Secondary outcomes:
measure: Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
Study officials:
affiliation: Assistant Professor
name: Jana Sacco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689346: High Tone Power Therapy for Hemiparetic Cerebral Palsy Children
Official title: High Tone Power Therapy Improves Balance and Quality of Life in Hemiparetic Cerebral Palsy Children: A Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiparetic Cerebral Palsy Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balance reactions and postural control are inadequate in children with CP which affect their daily living activities. So, different treatment modalities have been used to improve balance for cerebral palsy children. Recently, High tone power therapy is a new quantum leap in the field of electro therapy that can be used to stimulate nerves and muscles, so this randomized controlled study will be conducted to investigate the effect of high tone power therapy on balance and quality of life in hemiparetic cerebral palsy children.


Eligibility criteria: Inclusion criteria:

* Age ranged from 6 to 8 years.
* Height not less than one meter.
* Their spasticity will range from 1 to 1+ according to the Modified Ashworth Scale.
* Children have normal flexibility of the lower back muscles as adequate flexibility with normal muscle length is essential for proper joint function and efficient movement.
* Exclusion criteria:
* Children will not follow instructions.
* Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
* Tightness of the hip flexors.

Primary outcomes:
measure: balance assessment
timeFrame: change from base line at 4 weeks.
Secondary outcomes:
measure: quality of life assessment
timeFrame: change from base line at 4 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02241746: Malnutrition in Chinese Hospitalized Patients and Optimizing the Usage of Nutritional Screening Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 856
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary general hospital

Brief summary: The purpose of this study is:

* to diagnose malnutrition in Chinese hospitalized patients with four nutritional screening tools: mini-nutritional assessment - short form, subjective global assessment, malnutrition universal screening tool and nutritional risk screening 2002.
* to optimize the usage of nutritional screening tools based on data-mining methods.


Eligibility criteria: Inclusion Criteria:

* Ages≥18; admitted to hospital≥24h and did not receive operation until 8.am next day.

Exclusion Criteria:

* Patients who were pregnant or breast-feeding, and those who could not be interviewed or provide informed consent were excluded.

Primary outcomes:
measure: prevalence of malnutrition on admission detected by the four nutritional screening tools
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00922246: Insoles in Prevention of Lower Limb Injuries
Official title: Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Overuse Injuries
Keywords: overuse injuries
conscript
prevention
Lead sponsor: Finnish Defense Forces
Sponsor class: OTHER_GOV
First posted: 2009-06-17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To address whether custom made foot insoles could be used for primary prevention of lower limb overuse injuries, the investigators conducted a prospective, randomized controlled study comparing the use of insoles and standard shoes in healthy young adults exposed to increased physical activity.


Eligibility criteria: Inclusion criteria:

* healthy conscripts without any diagnosed deformities of lower limb by physician in premilitary physical examination

Exclusion criteria:

* major orthopaedic or medical conditions (e.g., diabetes, inflammatory arthritis, previous severe trauma (exclusion criteria for the military service)
* patients were excluded from our study if they already had insoles prescribed by a physician or a physiotherapist (eight patients)
* since only 2% of Finnish conscripts are females, they were excluded from the study

Primary outcomes:
measure: The main outcome measure in the present study was a lower limb overuse injury requiring a visit at the garrison physician and requiring suspension from the duty.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Centre of Military Medicine
Study officials:
References:
Clinical trial NCT06851546: Efficacy of Selective Laser Trabeculoplasty Targeting Nasal Versus Inferior 180-degree
Official title: Efficacy of Selective Laser Trabeculoplasty Targeting Nasal Versus Inferior 180-degree
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 102
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: The purpose of this study to optimize Selective Laser Trabeculoplasty (SLT) application when used in the management of open angle glaucoma (OAG)

Detailed description: The purpose of this research is to determine the most effective method in using Selective Laser Trabeculoplasty (SLT) for lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. We will investigate the IOP lowering differences between nasal 180° SLT and inferior 180° SLT,. The second stage will assess the effect of repeating SLT in the opposite 180° sector after 3 months.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Ability to comprehend the study procedures and agreement to proceed with primary SLT treatment
* Diagnosis of primary or secondary open angle glaucoma or glaucoma suspects with ocular hypertension
* Bilateral disease
* Pre-SLT IOP \>21 mmHg measured at least twice during patient's lifetime with or without medication
* Open angles with moderate to intense trabecular pigmentation
* Mild to moderate visual field defects (24-2 standard mean deviations better than the Swedish interactive thresholding algorithm standard of 12 dB)
* No adequate IOP control (low treatment compliance, substantial adverse effects with eyedrops, and at least 2 IOP measurements higher than the individualized target IOP)

Exclusion Criteria:

* Unwilling or unable to give consent
* Unable to attend scheduled post-operative visits
* Previous history of either laser treatment or intraocular surgery, except for non-complicated cataract surgery (performed \>6 months before SLT)
* History of ocular trauma
* Narrow angles
* Retinal detachment
* Active iris neovascularization or active proliferative retinopathy
* Active uveitis
* Monocular patients
* Current use of steroids (ocular, periocular, or systemic)

Primary outcomes:
measure: Difference in mean intraocular pressure (IOP)
timeFrame: Baseline, 3 months, 6 months, 9 months
Secondary outcomes:
measure: Change in intraocular pressure (IOP)
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Intraocular pressure (IOP) lowering eye drops
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Halifax
country: Canada
facility: Eye Care Centre, Victoria General Hospital
state: Nova Scotia
Study officials:
affiliation: Mayo Clinic
name: Arthur Sit
role: PRINCIPAL_INVESTIGATOR
References: