louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05533398: Stress Ball Use on Anxiety
Official title: Effect of Stress Ball Use on Anxiety in Haemodialysis Patients: A Single-blind Randomized Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Hemodialysis Complication
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Stress management in dialysis patients plays a key role in reducing these negativities and in maintaining both physical and mental well-being. In dialysis patients, on the other hand, the effectiveness of stress ball use on comfort and stress was evaluated, and no study was found that evaluated its effect on anxiety.

Detailed description: Stress ball is one of the non-pharmacological methods used to distract individuals when they consciously focus on a stimulus. With the squeezing of the ball, the nerves in the hands are stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide an acupressure effect. At the same time, it is the easiest and cheapest method that allows the mind to get away from stress and maintain the mental well-being of the person.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* Having any health problems related to the hand/arm to use the stress ball
* Patients who did not want to participate in the study

Primary outcomes:
measure: Change From Baseline Depression Level at 12 Dialysis Session
timeFrame: Up to 2 months
measure: Change From Baseline Anxiety Level at 12 Dialysis Session
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
References:
citation: Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
citation: Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.
citation: Cantekin I, Tan M. The influence of music therapy on perceived stressors and anxiety levels of hemodialysis patients. Ren Fail. 2013;35(1):105-9. doi: 10.3109/0886022X.2012.736294. Epub 2012 Nov 15.
Clinical trial NCT03413098: The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed description: Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F\&P trial nasal mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant

Primary outcomes:
measure: Ease of use
timeFrame: 2 weeks
measure: Acceptability
timeFrame: 2 weeks
Secondary outcomes:
measure: Objective leak data
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hastings
country: New Zealand
facility: Hastings Memorial Hospital
city: Wellington
country: New Zealand
facility: WellSleep
Study officials:
affiliation: Sponsor Employee
name: Sarah Gunson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03882398: Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease
Official title: Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease Population: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Exercise
Physical Activity
Quality of Life
Keywords: Neurodegenerative disorders
physical activity
balance
endurance
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: TITLE: Effects of a high-intensity progressive-cycle program on quality of life and motor symptomatology in Parkinson's disease population

BACKGROUND: The benefits of aerobic exercise in persons with Parkinson's disease (PD) have been widely studied; however, little research has been done on the effect of high-intensity aerobic exercise in this group.

HYPOTHESIS: The high-intensity aerobic training in pedaliers, combined with balance training, improves motor symptoms and quality of life in a population with Parkinson Disease, Hoehn \& Yahr 1-3.

OBJETIVES: To ascertain whether high-intensity aerobic training with exercise peddlers and balance training can improve motor symptoms and quality of life in a PD population of Hoehn \&Yahr (H\&Y) disability score 1-3.

METHODOLOGY Setting: Rehabilitation centers in secondary care. Design: A pilot randomized controlled trial. Participants: A total of 14 patients participated in the 8-week study. Interventions: They were comprised of a control group (n=7) that followed a balance protocol and an experimental group (n=7) that performed high intensity (70%) aerobic workout using an exercise peddler + a balance protocol once a week.

Main Outcome Measures: The primary outcome measures included the 8-Foot Up and Go, test, 6-minute walk test, test 2-minute step tets, Parkinson Disease Questionnaire-39 (PDQ39), Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson Disease, Hoehn \& Yahr score of 1-3.

Exclusion Criteria:

* History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout

Primary outcomes:
measure: Sintomatology of Parkinson Disease
timeFrame: 12 weeks
measure: Quality of life in Parkinson Disease: PDQ39
timeFrame: 12 weeks
measure: Physical Conditions
timeFrame: 12 weeks
measure: Balance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Universidad de Vigo
Study officials:
References:
Clinical trial NCT06388798: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic
Official title: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Psychoeducation
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-29
Enrollment: 78
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Summary:

Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation.

Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic.

Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey.

Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA).


Eligibility criteria: Inclusion Criteria:

* Working in a psychiatric clinic,
* Being a nurse

Exclusion Criteria:

* Not working in a psychiatric clinic

Primary outcomes:
measure: Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group.
timeFrame: 3 day
measure: Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation
timeFrame: 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Nermin Erdoğan, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02552498: Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the gingiva in order to characterize the kinetics of the blood flow changes in human subjects.

Detailed description: During surgical endodontics the cortical bone is exposed by elevating a full- thickness tissue flap. Cutting across mucosal blood vessels disturbs perfusion and causes ischemia. On the other hand, preserving sufficient blood flow of the soft tissue segment is important for the postoperative wound healing. In order to minimize the damage of the microvasculature of the operated area, the incision should be properly designed.

The investigators will model surgical incisions by strangulation of the gingiva of healthy human subjects based on the commonly applied endodontic incision such as horizontal, vertical and papilla base. The primary aim is to determine the effect of a short term disruption of the blood flow at the respective region on the surrounding area in order to assess the functionally active collateral circulation. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term of strangulation. The secondary aim is to assess the time course of the restoration of the circulation on the affected area.

Eligibility criteria: Inclusion Criteria:

* general good health

Exclusion Criteria:

* pregnancy
* smoking
* general diseases
* medicine taking except contraceptives

Primary outcomes:
measure: Change from baseline in blood flow during and after ischemia
timeFrame: baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00176098: Hypnosis for Eye Surgery
Official title: Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cataract
Keywords: Cataract surgery
Hypnosis
C11.510.245
F04.754.424.771
Suggestion
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.


Eligibility criteria: Inclusion Criteria:

* Cataract

Exclusion Criteria:

* Uncorrected hearing disability
* Pharmacological beta-blockade

Primary outcomes:
measure: Reduction of perioperative stress
measure: Improvement of patient comfort and safety
Secondary outcomes:
measure: Correlation of hypnotic depth with bispectral index (BIS)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
Study officials:
affiliation: Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
name: Thomas Frietsch, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05474898: IONTOPHORESIS Versus Ultrasound in Mechanical Neck Pain
Official title: Magnesium Sulphate Iontophoresis Versus High- Power Pain Threshold Ultrasound in Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effects of Magnesium Sulphate Iontophoresis versus High Power Pain Threshold Ultrasound on pain, function and range of motion on active MTrPs found in the upper trapezius.

Detailed description: Myofascial pain syndrome (MPS) is a musculoskeletal chronic pain disorder that affects the majority of pain population and characterized by the presence of trigger points. MPS is usually associated with tenderness, spasm, movement limitation and referred pain .

Myofascial trigger points (MTrPs) are hyperirritable taut fibers of skeletal muscle. The taut fibers within the muscle create palpable nodules that may cause local pain, and refer pain elsewhere with soft tissue examination .

Eligibility criteria: Inclusion Criteria:

* Subjects, with age ranged from 19-23 years (Forman et al, 2014) from both genders. The subjects had active MTrPs in the upper fibers of trapezius muscle.

Exclusion Criteria:

* • History of whiplash injury.

  * History of cervical spine surgery.
  * Cervical radiculopathy or myelopathy.
  * Having undergone physical therapy within the past three months before the study.
  * Non- rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection.
  * Rheumatologic condition as poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Primary outcomes:
measure: pain intensity
timeFrame: up to four weeks
Secondary outcomes:
measure: Pain pressure threshold (PPT)
timeFrame: up to four weeks
measure: neck disability
timeFrame: up to four weeks
measure: range of motion
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT06565598: Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
Official title: Observation on the Efficacy of Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonfunctional Kidney
Renal Cancer
Keywords: Laparoscopic radical nephrectomy
Transperitoneal approach
Robotic surgery
Tubeless
Lead sponsor: The First People's Hospital of Xiushui
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization

Detailed description: In this study, a multi-center retrospective study was conducted to evaluate the clinical efficacy of single-layer robot-assisted peritoneal retroperitoneal radical nephrectomy in patients with nephrectomy, and to compare the safety and effectiveness of traditional robot-assisted peritoneal radical nephrectomy

Eligibility criteria: Inclusion Criteria:

* Patients with various causes requiring radical nephrectomy

Exclusion Criteria:

* patients who could not tolerate laparoscopic surgery for various reasons
* patients whose preoperative blood pressure and blood glucose were not controlled to normal
* patients with contralateral nonfunctioning kidney or solitary kidney
* Multiple organ surgery at the same time

Primary outcomes:
measure: intraoperative blood loss
timeFrame: 24 months
measure: postoperative time of getting out of bed
timeFrame: 24 months
measure: postoperative hospital stay
timeFrame: 2-5 Days
measure: Whether to convert to laparotomy or not
timeFrame: 24 months
measure: Operation time
timeFrame: 1-3 Hours
measure: whether the tumor was completely removed
timeFrame: 24 months
Secondary outcomes:
measure: Clavien-Dindo grading
timeFrame: 24 months
Other outcomes:
Locations:
city: Jiujiang
country: China
facility: First People 's Hospital of Xiushui
Study officials:
References:
Clinical trial NCT03199898: Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
Official title: Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Lung/Growth & Development
Respiration, artificial
Reproducibility of Results
Observer Variation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Helse Nord-Trøndelag HF
First posted: 2017-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants born \<35 weeks of gestational age. the included infants will be stratified in 3 gestational age groups.

Brief summary: Depending on their gestational age, preterm infants need several weeks with different types of breathing-support due to immature development of the lungs, respiratory muscles, chest-wall and respiratory center in the brain. WHO's recommendation on interventions to improve preterm birth outcomes underline the need for more research on respiratory support in infants born preterm. This study will test inter-rater and intra-rater reliability of the Silverman-Andersen Retraction Score, which is a systematic clinical scoring tool for the respiratory work and the severity of respiratory distress in preterm infants. It will examine if there is consistency in the assessments done by doctors and nurses, and also if the observations correlate with technological monitoring. This easy to use scoring tool will help to determine the grade of respiratory distress, to assess respiratory exacerbation, to decide when to start weaning from respiratory support, and to give the best respiratory treatment to the child. This study will contribute to optimize care for preterm infants with respiratory distress.


Eligibility criteria: Inclusion Criteria:

* born \<35 weeks gestational age

Exclusion Criteria:

* need of muscle relaxation
* hemodynamic instability

Primary outcomes:
measure: inter-rater reliability of Silverman-Andersen Retraction Score
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Elisabeth Selvaag, md
role: STUDY_DIRECTOR
References: