louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05574595: Effect on Pain and Comfort Associated With Fistula Puncture
Official title: The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Patients
Keywords: pain
comfort
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis.

Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen'd was used to calculate the size.

Detailed description: It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012).

Participant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice.

As far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture.

Eligibility criteria: Inclusion Criteria:

* be volunteering,
* 18 years or older,
* receiving hemodialysis treatment for at least 6 months
* not any hearing problem.

Exclusion Criteria:

* have hearing problem
* not be volunteering.

Primary outcomes:
measure: The Efficacy of Music on Pain Level
timeFrame: 7 days
Secondary outcomes:
measure: The Efficacy of Music on Comfort Level
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Gümüşhane Universıty
name: Nurşen KULAKAÇ, pHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041795: Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Nervous System Diseases
Chemotherapy-Induced Peripheral Neuropathy
Lead sponsor: NeoTherapeutics
Sponsor class: INDUSTRY
First posted: 2002-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
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 will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.


Eligibility criteria: * Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy.
* Sensory or motor neuropathy must be \>/= grade 2 per Common Toxicity Criteria at baseline.
* In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable.
* Patient must have normal hematological cell counts.
* Patient must have a life expectancy of \>/= 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Mission Hills
country: United States
facility: Providence Holy Cross Medical Center
state: California
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
Study officials:
References:
citation: Grundman M, Farlow M, Peavy G, Kim HT, Capparelli E, Schultz AN, Salmon DP, Ferris SH, Mobs R, Thomas RG, Schafer K, Campbell K, Hake AM, Schoos B, Thal LJ; Alzheimer's Disease Cooperative Study. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci. 2002 Jun;18(3):283-93. doi: 10.1385/jmn:18:3:283.
citation: Di Iorio P, Virgilio A, Giuliani P, Ballerini P, Vianale G, Middlemiss PJ, Rathbone MP, Ciccarelli R. AIT-082 is neuroprotective against kainate-induced neuronal injury in rats. Exp Neurol. 2001 Jun;169(2):392-9. doi: 10.1006/exnr.2001.7654.
citation: Rathbone MP, Middlemiss PJ, Gysbers JW, Andrew C, Herman MA, Reed JK, Ciccarelli R, Di Iorio P, Caciagli F. Trophic effects of purines in neurons and glial cells. Prog Neurobiol. 1999 Dec;59(6):663-90. doi: 10.1016/s0301-0082(99)00017-9.
citation: Middlemiss PJ, Glasky AJ, Rathbone MP, Werstuik E, Hindley S, Gysbers J. AIT-082, a unique purine derivative, enhances nerve growth factor mediated neurite outgrowth from PC12 cells. Neurosci Lett. 1995 Oct 20;199(2):131-4. doi: 10.1016/0304-3940(95)12029-4.
Clinical trial NCT02432495: Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fractures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 65 years or older with an ASA score of 2 or higher who had undergone either anterior screw fixation or halo immobilization of type II odontoid fractures

Brief summary: The management of type II odontoid fractures in geriatric trauma victims remains a source of substantial controversy. The purpose of this study was to compare anterior screw fixation with halo-vest-immobilization in patients with type II odontoid fractures.


Eligibility criteria: Inclusion Criteria:

* patients aged 65 years or older with an ASA (= American society of anesthesiologists) score of 2 or higher
* complete sets of collected data and a follow-up monitoring of at least five years

Exclusion Criteria:

* type III odontoid fractures
* patients with incomplete data sets
* patients with penetrating mechanism of injury or congenital cervical spine anomalies

Primary outcomes:
measure: neurological deficits
timeFrame: at least 60 months follow up
measure: radiographic outcome (documentation of boney union)
timeFrame: at least 60 months follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02834195: Types of Upper Limb and Hand in Patients With Cerebral Palsy
Official title: Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
reliability
upper limb and hand patterns
classification
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 111
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebral palsy

Brief summary: Cerebral palsy (CP) has been defined as "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain".

Investigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns.

The aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.


Eligibility criteria: Inclusion Criteria:

* cerebral palsy

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in upper limb pattern classification of each examiner between day 1 and month 2
timeFrame: examiner classification at day 1 and at month 2.
measure: Change in hand pattern classification of each examiner between day 1 and month 2
timeFrame: examiner classification at day 1 and at month 2.
measure: Change between examiner classification and the expert examiner classification
timeFrame: Expert examiner classification (day 1) and examiner classification (week 4)
measure: Change between examiner classification and the expert examiner classification
timeFrame: Expert examiner classification (day 1) and examiner classification (week 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A
Study officials:
affiliation: Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
name: Sandrine TOUZET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580095: Artificial Intelligence for Improved Echocardiography
Official title: Technology Revisiting Ultrasound Solutions of Tomorrow - Artificial Intelligence for Improved Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2020-10-08
Enrollment: 88
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 purpose of this study is to assess the effect of artificial intelligence algorithms on image quality in echocardiography.

Detailed description: The study population will be recruited from appointed patients at the Clinic of Cardiology, St. Olavs Hospital. After being informed about the study, all patients giving informed consent and meeting the eligibility requirements will undergo their standard clinical echocardiographic exam performed by a sonographer at the clinic. Two additional examinations will then be performed by a different sonographer and an expert cardiologist, respectively.

In one of the study arms the sonographer randomized to perform the second exam will use the AI algorithm (intervention).

Eligibility criteria: Inclusion Criteria:

* Capacity to consent

Exclusion Criteria:

* Indication for echocardiographic contrast agents

Primary outcomes:
measure: Left ventricular apical foreshortening
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
measure: Image quality
timeFrame: 0 days
measure: Inter-observer variation of left ventricular size
timeFrame: 0 days
measure: Inter-observer variation of left ventricular function
timeFrame: 0 days
measure: Validation of AI algorithm to detect foreshortening
timeFrame: 0 days
measure: Inter-observer variation of left atrial size
timeFrame: 0 days
measure: Inter-observer variation of left atrial function
timeFrame: 0 days
measure: Development of AI algorithm for real-time assessment of left atrium
timeFrame: 0 days
measure: Variation by methodology
timeFrame: 0 days
Locations:
city: Trondheim
country: Norway
facility: St. Olav University Hospital
Study officials:
References:
Clinical trial NCT06428695: Education Session to Improve Program Adherence
Official title: Implementation of Education on Calorie Tracking Application to Improve Adherence to a Calorie Restricted Weight Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Management
Keywords: calorie tracking
weight loss
weight management program
food intake
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subject population will consist of adults 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2
Primary purpose: SUPPORTIVE_CARE

Brief summary: To examine is user knowledge of a dietary self-monitoring (DSM) calorie tracking app and improving patient adherence to daily caloric food intake to help with weight loss.

Detailed description: The research question guiding this project is: In adults with a BMI greater than 25 kg/m2, does a 1-hour education session on using a calorie-tracking application improve adherence to a calorie-restricted weight management program over eight weeks? This project aimed to increase patient knowledge with the DSM tool. To Increase adherence to the calorie-restricted diet program and, finally, to increase weight loss in the program participants of the 8-week program

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2

Exclusion Criteria:

* Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2

Primary outcomes:
measure: Perceived Competence Scale (PCS) Score
timeFrame: Baseline
measure: Perceived Competence Scale (PCS) Score
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Melanie Smith, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343495: UV and Bluelight Dosimetry
Official title: Pilot Studies of UV-A, UV-B, and Blue-light Dosimetry Sensors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Environmental Exposure
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

Brief summary: The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Subjects speaking English

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and unable to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape or rubber bands/elastic
* Lack of proficiency in English
* Skin disorders affecting skin integrity

Primary outcomes:
measure: Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings.
timeFrame: Time Frame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06370195: Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome
Official title: Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson's Syndrome
Lead sponsor: Buraidah Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Detailed description: Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.

This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Drooling amount
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: day 1 and day 10
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 10
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Louis Wi
role: STUDY_DIRECTOR
References:
Clinical trial NCT04366895: 3D -Printed Single Implant Overdentures
Official title: 3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Detailed description: Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.

Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Eligibility criteria: inclusion criteria

* the participant should be completely edentulous ranging in age from 35 to 75 years
* Angle's class I skeletal relationship
* normal facial symmetry
* adequate inter-arch space not less than 12mm
* should be a cooperative patient -

Exclusion Criteria:

* temporomandibular disorders
* uncontrolled diabetes
* bleeding disorders or anticoagulant therapy
* flabby tissues or sharp mandibular residual ridge
* neuromuscular disorders
* Angle's class II and III skeletal relationship.
* Patients who were heavy smokers
* chemotherapy or radiotherapy or with severe psychiatric disorders

Primary outcomes:
measure: Implant survival
timeFrame: 1 year
Secondary outcomes:
measure: Survival rate of overdentures
timeFrame: 1 year
measure: maximum biting force (MBF)
timeFrame: 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Msa Uni
Study officials:
affiliation: Lecturer
name: Dina Elawady, PHD
role: PRINCIPAL_INVESTIGATOR
References: