louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01466140: Effects of Writing Down the Request for Help on Patient Satisfaction in General Practices
Official title: Effects of Writing Down the Request for Help With Regard to Patient Satisfaction in General Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Doctor Satisfaction
Duration of Consultation
Keywords: Patient Satisfaction
Request for help
General practice
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to determine whether exploring the request for help more thoroughly improves patient satisfaction in general practice (primary care).

Detailed description: Patient satisfaction has been an important topic of interest in primary health care during the last decade(s). Many factors during the consultation influence patient satisfaction. One of the aspects in a consultation is the request for help; especially in primary care the request for help has been recognised as an important aspect influencing patient satisfaction. The investigators hypothesized that exploring the request for help more thoroughly would improve patient satisfaction in general practice.

Eligibility criteria: Inclusion Criteria:

* All patients with a new request for help.

Exclusion Criteria:

* Dementia
* Mental disability
* No or little knowledge of the Dutch language
* Illiteracy
* Limited vision

Primary outcomes:
measure: Patient satisfaction measured with the Consultation Satisfaction Questionnaire
timeFrame: 15-30 minutes (after the consultation patients filled in the questionnaire)
Secondary outcomes:
measure: Patient satisfaction measured with the Visual Analog Scale
timeFrame: 15-30 minutes (patients filled in the Visual Analog Scale after the consultation)
measure: Doctor satisfaction measured with the Visual Analog Scale
timeFrame: 15-30 minutes (general pracitioners filled in the Visual Analog Scale after the consultation)
measure: Duration of the consultation
timeFrame: 15-30 minutes (after the consultation the doctor measured the time with a stopwatch)
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Clinics
state: Overijssel
Study officials:
affiliation: Medical Research Centre
name: Henk Bilo
role: STUDY_CHAIR
References:
Clinical trial NCT06840340: Customised Mouthguards on Baseball and Softball Performance
Official title: Effects of Concurrent Activiation Potentation Induced by Customized Mouth Guard on Baseball and Softball Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Manifestations
Control Condition
Keywords: concurrent activation potentiation
bite force
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Whether the use of customised mouthguards is effective in improving the athletic performance of baseball and softball performance

Detailed description: This study recruited 45 baseball and softball players, including 30 fielders and 15 pitchers. Using a randomized crossover experimental design, the study was divided into randomised divided into customised mouthguards trial (MG) and control trial (CON) without temporal positioning. After the participants wore the mouthguard, they performed the vertical jump and grip strength tests sequentially. At the end of the test, depending on the pitcher or fielder, a baseball pitching ability test or a hitting ability test was conducted using a radar baseball tracking system. It is expected to analyze the vertical jump height, grip strength, pitchers' straight and changeup ball speeds, rotation speeds, degree of displacement, on-base and off-base locations. Hitting ability was expected to be documented with respect to initial velocity, elevation, and consistency of elevation.

Eligibility criteria: Inclusion Criteria:

* has won the top 8 national level baseball of softball championships in the last three years.
* no cardiovascular and joint diseases.
* aged 20 or above who are adults
* continuing to train professionally more than 5 days a week for the past year

Exclusion Criteria:

* have not won the top 8 national baseball or softball championships in the past three years.
* have a cardiovascular or joint disease, or any injuries that may be impaired by exercise.
* participants who are underage or not in regular baseball or softball training
* have injury to the temporomandibular joint.

Primary outcomes:
measure: exit velocity
timeFrame: Immediately after wore customized mouthguard or not
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
state: North
Study officials:
affiliation: National Taiwan University of Sport
name: Chih Hui Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720940: Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin
Official title: Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
First posted: 2012-11-02
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.

This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

Participants are invited if they have an infection that requires prolonged vancomycin therapy (\> more than 10 days).


Eligibility criteria: Inclusion Criteria:

* Adults aged 21-80 years
* Documented infection requiring prolonged (\> 10 days) of vancomycin therapy
* Creatinine clearance \> 50 ml/min (using Cockroft-Gault equation)

Exclusion Criteria:

* Patient already received 7 days or more of vancomycin therapy
* Pregnancy
* Severe burns \> 40% body surface area
* Spinal cord injuries
* Participation in another interventional trial in previous 30 days
* Inability to obtain informed consent

Primary outcomes:
measure: nephrotoxicity
timeFrame: occurring any time while on vancomycin treatment up to 14 days post treatment completion
Secondary outcomes:
measure: biomarkers for detection of early nephrotoxicity
timeFrame: measured weekly from the date of randomization until 14 days post completion of vancomycin
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT02386644: Transperineal Ultrasonography and Premature Rupture of Membranes
Official title: Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Premature Rupture of the Membranes
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 105
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.

Detailed description: Women with early and late preterm pregnancies with a complaint of fluid leakage are enrolled in the study. Prior to speculum examination, sagittal view of the birth canal and transverse view of cervix and fornices are obtained with transperineal technique and images are stored. Then speculum examination for pooling, nitrazine test and placental microglobulin-1 tests are performed and results are recorded. Ultrasound images are analysed by an observer blind to physical examination findings. Hypoechogenic fluid appearance of adequate size around the cervix and in the fornices are considered positive. Placental microglobulin-1 test is used as reference. Sensitivity and specificity values are calculated for each test.

Eligibility criteria: Inclusion Criteria:

* Women with early and late preterm pregnancies, (i.e., women above 24th and below 37th week of gestation)
* Pregnant women with a complaint of fluid leakage

Exclusion Criteria:

* Women with term pregnancies (i.e., women above 37th week of gestation)
* Women with unviable pregnancies (i.e., women below 24th week of gestation)
* Women in active labor (i.e., cervical dilatation above 4cm during admission)
* Women with vaginal bleeding

Primary outcomes:
measure: True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Study officials:
affiliation: Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
name: Acar F Koc, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03933644: Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
Official title: Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Leak Pressure
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA.

It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP).

The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA.

The study also evaluates the OLP after 15 minutes and after 30 minutes.


Eligibility criteria: Inclusion Criteria:

* ASA I - 3
* Signed informed consent
* Age 18 - 90 years
* Edentolous (or partial) patients
* Patients scheduled for elective surgery

Exclusion Criteria:

* Patients with a known or predicted difficult airway
* Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
* Patients at risk for aspiration
* Body mass index (BMI) \> 40 kg/m2

Primary outcomes:
measure: Oropharyngeal Leak Pressure
timeFrame: immediately after insertion
Secondary outcomes:
measure: Oropharyngeal Leak Pressure
timeFrame: 15 minutes
measure: Oropharyngeal Leak Pressure
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: MUInnsbruck
Study officials:
affiliation: Departement for Anaesthesia and Intensive Care - Medical University Innsbruck
name: Lukas Gasteiger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499144: A Modified Approach for the Closure of Oral Sinus Communications
Official title: A Modified Approach for the Closure of Oral Sinus Communications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery Site Fistula
Keywords: Extraction
Oro-antral communication
Oro-antral fistula
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case series of a new surgical design
Primary purpose: TREATMENT

Brief summary: The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate


Eligibility criteria: Inclusion Criteria:

* Patient with diagnosis of Oro-antral communication
* Patients with adequate radiographic status
* Patients who read and signed the informed consent
* Patients without periodontal disease
* Patients≥18

Exclusion Criteria:

* Pregnancy or breastfeeding patients
* Patients compliance and patients with mental disorders
* Patients with diabetes
* Patients with osteonecrosis
* Patients with head and neck cancer

Primary outcomes:
measure: Closure of the communication
timeFrame: Day 30
Secondary outcomes:
measure: Pain and discomfort
timeFrame: Day 30
Other outcomes:
Locations:
city: Siena
country: Italy
facility: University of Siena- Department of medical biotechnologies
Study officials:
affiliation: University of Siena
name: Ralph Habib, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02298244: Safety Procedure Pulmonary Artery Denervation in Addition to Pulmonary Vein Isolation Combined With Ganglionated Plexi Ablation in Patients With Persistent Atrial Fibrillation and Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Hypertension, Pulmonary
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes
Cardiovascular Diseases
Lung Diseases
Keywords: Pulmonary Hypertension
Atrial Fibrillation
Pulmonary Arterial Denervation
Safety
Pulmonary Arterial GP Ablation
Lead sponsor: Krasnoyarsk Regional Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some patients with a long history of AF develops PH "reactive" type with an increase in pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular wall. RFA PVI + RFA GP is the "gold standard" in the treatment of patients with persistent AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is adjacent to the roof and part of the front of the left atrium. In the projection of this area are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency denervation of the pulmonary artery improves the quality of life in patients with PH.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic, drug - refractory AF ( inefficiency 1C or III Class antiarrhythmic drugs), history of AF 6 months or more without the restoration of sinus rhythm.
* MPAP ≥25 mmHg
* PCWP≥15 mmHg
* Pulmonary vascular resistance (PVR). The PVR =(mPAP-PCWP)/ carbon monoxide\] \> 2.5 woods unit

Exclusion Criteria:

* Left ventricular ejection fraction \<35%
* Diameter LA\> 60 mm on transthoracic echocardiography in the "M" -Mode or volume of LA more than 140 ml
* Significant regurgitation at the mitral valve
* Uncorrected congenital heart disease
* RFA PVI, RFA GP, PADN in history
* Foregoing heart surgery
* Life expectancy less than 12 months
* WHO group I, III, IV, V pulmonary artery hypertension
* Tricuspid valve stenosis, pulmonary supravalve stenosis.
* Cancer
* Pregnancy
* Thromboembolism LA history
* Hyperthyroidism.

Primary outcomes:
measure: death
timeFrame: 6 months
measure: Perioperative Complications
timeFrame: 6 months
Secondary outcomes:
measure: Mean Pulmonary Artery Pressure
timeFrame: 6 months
measure: recurrence of AF / AFL / AT
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: 6-minute walk distance
timeFrame: 6 months
measure: Pulmonary vascular resistance
timeFrame: 1 month
measure: Assessment of respiratory function
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06493344: The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy
Official title: The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy. Assessment of the Kinematics, Balance and Functional Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Gait, Spastic
Motor Disorders
Functional Neurological Disorder
Keywords: cerebral palsy
crouch gait
physiotherapy
balance
kinematic analysis
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

The children who participated in the study, aged 12 - 15 years old, were diagnosed with spastic cerebral palsy, level III according to the classification of the GMFCS.

Exclusion Criteria:

From the study, they were excluded:

1. children who have received botulinum toxin injection up to 3 months before,
2. children who have had selective rhizotomy surgery up to 1 year before,
3. children who have a baclofen pump,
4. children with uncontrolled epilepsy,
5. children with cognitive deficits who cannot follow verbal instructions.

Primary outcomes:
measure: Kinovea
timeFrame: up to 16 weeks (every 4 weeks)
measure: Gross Motor Function Measure 88 (GMFM-88)
timeFrame: up to 16 weeks (every 4 weeks)
measure: Timed Up and Go
timeFrame: up to 16 weeks (every 4 weeks)
measure: Sit to Stand (STS) test of the NeuroCom® Balance Master®
timeFrame: up to 16 weeks (every 4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Lamía
country: Greece
facility: Department of Physiotherapy - University of Thessaly
state: Phthiotis
Study officials:
affiliation: University of Thessaly
name: George Paras, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.
citation: Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
Clinical trial NCT05640544: Gamma Entrainment Improve the Recovery of Awareness
Official title: Gamma Entrainment Improve the Recovery of Awareness in Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to elucidate the occurrence of Gamma entrainment and optimize the acousto-optic stimulation parameters to induce it in patients with disorders of consciousness (DOC), to explore the prognostic value of gamma entrainment in patients with DOC, and to clarify the effect of gamma entrainment on the recovery of awareness in DOC patients. This study is divided into three parts. The first and third parts are prospective cohort studies, the second part is a randomized cross control study. We recruit DOC patients, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS). The patients receive sound and light stimulation in the Gamma band, and the changes of EEG are observed simultaneously to explore the occurrence of Gamma entrainment. Meanwhile, the changes of clinical behavior of patients before and after stimulation are evaluated.


Eligibility criteria: Inclusion Criteria:

Age 16-80 years; Clinical diagnosis of VS/UWS or MCS according to the CRS-R score within one week after admission; Time post-onset \> 28 days.

Exclusion Criteria:

Previous history of acquired brain injury or psychiatric or neurodegenerative diseases; Clinical diagnosis of epilepsy; Visual or auditory pathway damage; Life threatening comorbidity, coexisting neoplasms, severe organ dysfunction, or unstable clinical condition (e.g., hemodynamic instability or severe respiratory failure); Incomplete clinical data.

Primary outcomes:
measure: The changes of EEG during stimulation procedure
timeFrame: Synchronous recording during stimulation procedure
Secondary outcomes:
measure: CRS-R scale
timeFrame: at two weeks, 3 months, 6 months and 1 year after the onset.
measure: Glasgow Outcome Scale - Extended (GOS-E)
timeFrame: at two weeks, 3 months, 6 months and 1 year after the onset.
measure: Modified Rankin Scale (mRS)
timeFrame: at two weeks, 3 months, 6 months and 1 year after the onset.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Neurology, Xijing Hospital, Air Force Medical University
Study officials:
References:
Clinical trial NCT00714844: Insulin Detemir and Waist Circumference
Official title: Waist Circumference Reduction After Insulin Detemir Treatment in Type 2 Diabetes Patients Previously Treated With NPH Insulin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: insulin therapy
insulin detemir
waist circumference
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients accessing the Diabetologic Centre

Brief summary: The purpose of the study is to investigate the weight-sparing effect of detemir and assess glycemic control and treatment satisfaction when switching from NPH to detemir, to improve metabolic control.


Eligibility criteria: Inclusion Criteria:

* Duration of type 2 diabetes for at least 12 months
* BMI \<40 kg/m2
* HbA1c \>7.5%
* Requiring basal insulin replacement and previously treated with NPH insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mandosi E, Fallarino M, Rossetti M, Gatti A, Morano S. Waist circumference reduction after insulin detemir therapy in type 2 diabetes patients previously treated with NPH. Diabetes Res Clin Pract. 2009 May;84(2):e18-20. doi: 10.1016/j.diabres.2009.02.006. Epub 2009 Mar 17.