louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04762927: Metric Properties of de Morton Mobility Index
Official title: Metric Properties of de Morton Mobility Index in Rehabilitation Patients With Musculoskeletal Impairments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Keywords: DEMMI
outcome measurement
physiotherapy
clinimetric properties
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with musculoskeletal impairments with or without impairments of peripheral nerves

Brief summary: Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated.

Detailed description: Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome measures. Known-groups validity will be demonstrated by differences in DEMMI scores between patients who were not able to walk and those who were able to walk with or without walking aid. Predictive validity of DEMMI at admission for functional independence at discharge from rehabilitation will be estimated. The minimal clinically important difference of DEMMI, responsiveness and floor or ceiling effects will also be estimated.

Eligibility criteria: Inclusion Criteria:

* admission to inpatient rehabilitation
* written informed consent

Exclusion Criteria:

* associated impairments of the central nervous system or other severe health conditions

Primary outcomes:
measure: de Morton Mobility Index - change
timeFrame: Approximately 30 days (difference between admission and discharge)
Secondary outcomes:
measure: Ten-meter Walk Test
timeFrame: Approximately 30 days (difference between admission and discharge)
measure: Six-minute Walk Test - change
timeFrame: Approximately 30 days (difference between admission and discharge)
measure: Functional Independence Measure - change
timeFrame: Approximately 30 days (difference between admission and discharge)
measure: EQ-5D-3L - change
timeFrame: Approximately 30 days (difference between admission and discharge)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Aleksander Zupanc, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01480427: Assessment of Quality of Life in Food Allergic Children
Official title: Assessment of Quality of Life in Food Allergic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: Children aged 0-12 years
IgE mediated food allergy
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 60
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population of children 0-12 years old

Brief summary: The purpose of this study is

1. To validate in french quality of life questionnaires for food allergic children
2. To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition
3. To validate a didactic game for food allergic children


Eligibility criteria: Inclusion Criteria:

* French speaking children with confirmed IgE mediated food allergy
* Aged 0-12 years old

Exclusion Criteria:

* Inclusion in another trial
* Chronic severe diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Lausanne Hospitals
name: Jacqueline Wassenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wassenberg J, Cochard MM, Dunngalvin A, Ballabeni P, Flokstra-de Blok BM, Newman CJ, Hofer M, Eigenmann PA. Parent perceived quality of life is age-dependent in children with food allergy. Pediatr Allergy Immunol. 2012 Aug;23(5):412-9. doi: 10.1111/j.1399-3038.2012.01310.x. Epub 2012 May 3.
Clinical trial NCT04929327: Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting
Official title: Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting Versus Total Etch Resin Based Sealant in High Caries Risk Patients After One Year Follow up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries; Initial
Pit and Fissure Caries
Keywords: Pit and fissure sealant
Sandblasting
Air abrasion
Retention rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.


Eligibility criteria: Inclusion Criteria:

* Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
* Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

Exclusion Criteria:

* An individual with no previous caries experience and well coalesced pits and fissures.
* Partially erupted teeth.

  * Teeth with cavitation or caries of the dentin.
* Teeth with dental fluorosis, Hypocalcification

Primary outcomes:
measure: Retention rate
timeFrame: Change from baseline at 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Cairo University
name: Rawda Hesham H. Abd ElAziz, Post Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02279927: Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy
Official title: Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ureterolithiasis
Nephrolithiasis
Keywords: Ureteroscopy
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2014-10-31
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: A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

Detailed description: Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments

Eligibility criteria: Inclusion Criteria:

* Patients who are planned for ureteroscopy \\ retrograde intra renal surgery (RIRS) for stone treatment

Exclusion Criteria:

* known ureteral stricture
* severe immune deficiency
* patients after urinary diversion surgery
* patients with single \\ ectopic\\ implanted kidney
* double collecting system
* severe thrombocytopenia
* patients taking anticoagulant drugs that cannot be stooped before the operation

Primary outcomes:
measure: Stone free rate
timeFrame: 1 month
Secondary outcomes:
measure: Duration of operation
timeFrame: Immediate
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel MC
name: Yuval Freifeld
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496727: Serratus Anterior Block for Video-assisted Thoracoscopic Surgery
Official title: Analgesic Effectiveness of Serratus Anterior Block for Video-assisted Thoracoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: pain, VATS
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VATS ( Video-assisted thoracoscopy)

Brief summary: Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. The serratus plane block is used in our clinic for postoperative analgesia in VATS operations. The aim of this study was to evaluate the postoperative pain scores and use of analgesia in patients performed with the serratus plane block in VATS operations in a

1-year period.

Detailed description: Approval for the study was granted by the Clinical Research Ethics Committee and all procedures were carried out in accordance with the Helsinki Declaration. A retrospective examination was made of the anesthesia forms of patients underwent VATS May 2016 and June 2017. Due to incomplete data of 1 of these 35 patients, that case was excluded from the study. The patients were divided into two groups. 24 patients were performed SAPB and iv PCA (intravenous patient controlled analgesia) and 10 patient's pain management were provided with only PCA. No block was administered to 10 patients because of anticoagulant therapy and patient refused block application. The demographic data of the patients (age, gender, operation type, and duration) were obtained from the anesthesia forms. The postoperative pain scores of the patients, evaluated with a visual analog scale (VAS) at 1, 6, 12 and 24 hours postoperatively and the postoperative doses of analgesia used were taken from the block pain follow-up forms

Eligibility criteria: Inclusion Criteria:

VATS( Video-assisted thoracoscopy) operation

a.Serratus anterior plane block b.patient controlled analgesia

Exclusion Criteria:

missing data written consent

Primary outcomes:
measure: Postoperative analgesic consumption
timeFrame: up to 24 hour
Secondary outcomes:
measure: Post-operative pain scores
timeFrame: up to 24 hour
Other outcomes:
measure: Complications
timeFrame: Postoperative 1 week
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University Hospital
city: Kahramanmaraş
country: Turkey
facility: KahramanmarasSIU
Study officials:
References:
citation: Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
Clinical trial NCT00423527: Levetiracetam in Central Pain in Multiple Sclerosis(MS)
Official title: Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
central pain
levetiracetam
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-01-18
Enrollment: 30
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: Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* ms diagnosis verified
* age \> 18 years
* central pain symptoms for more than 3 months
* central pain diagnosis confirmed by neurological examination
* adequate anticonceptive treatment for women with child bearing potential
* informed consent
* baseline pain of more than 4 on numeric rating scale

Exclusion Criteria:

* other cause of pain
* previous allergic reaction towards levetiracetam
* known adverse drug reaction on levetiracetam
* pregnancy
* severe disease
* inability to follow study protocol
* treatment with antidepressants, other anticonvulsants or opioids

Primary outcomes:
measure: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)
timeFrame: Weekly
Secondary outcomes:
measure: Pain rated on a 0 to 10 point numeric rating scale
timeFrame: Daily
measure: Pain subtypes rated on the same scale.
timeFrame: Daily
measure: Brush-evoked pain
timeFrame: Baseline and end of each treatment period
measure: Pin-prick-evoked pain
timeFrame: Daily
measure: Cold-evoked pain
timeFrame: Daily
measure: Health related quality of life (SF36)
timeFrame: Baseline and end of each treatment period
measure: Pain related sleep disturbance
timeFrame: Daily
measure: Use of escape medication
timeFrame: Daily
measure: Muscle spasms as measured on 2 different scales
timeFrame: Baseline and end of each treatment period
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Neurology, Odense University Hospital
Study officials:
affiliation: Department of Neurology, Odense Unviersity Hospital
name: Søren H Sindrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07014527: Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study
Official title: Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge Atrophy
ATROPHYC EDENTULOUS JAW
Edentulous Maxilla
Edentulous Alveolar Ridge In Mandible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed


Eligibility criteria: Inclusion Criteria:

* Adults patients with severely atrophic alveolar ridges in both maxilla and mandible.

Exclusion Criteria:

* Alveolar bone dimensions that can allow for root form implant placement

Primary outcomes:
measure: Accuracy
timeFrame: immediately postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
Study officials:
References:
Clinical trial NCT03517527: The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients
Official title: The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Metabolic Control
Walking Exercise
Transtheoretical Model
Nurse
Lead sponsor: Munzur University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 152
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: SUPPORTIVE_CARE

Brief summary: OBJECTIVE This study aims to find out the effects of walking exercise training, which is given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior and metabolic control in type 2 diabetic patients.

RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic patients providing the criteria of the study and followed-up by the diabetes polyclinic of Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and pedometer were used to collect the data. TTM based training was given to the intervention group according to the patients' change stages at hospital 10 weeks once per every 2 weeks. PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9 months after the pre-test again.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with type-2 diabetes at least six months before, received basic diabetes information, received insulin and/or oral antidiabetic treatment, whose arterial blood pressure was in systolic ≤ 160 mmHg and diastolic ≤ 100 mmHg, who had HbA1c 7% and over, who were literate and had no communication problems were included in the study.

Exclusion Criteria:

* Those who had developed diabetes-related complications (advanced), were pregnant, diagnosed with cancer, had physical and mental problems that prevent walking were excluded from the study.

Primary outcomes:
measure: Patient Presentation Form
timeFrame: baseline collected
measure: questions that evaluate the metabolic control variables.
timeFrame: Change from Baseline at 9 months
measure: Stages of Change for Exercise Questionnaire
timeFrame: Change from Baseline at 9 months
measure: Exercise Processes of Change Scale
timeFrame: Change from Baseline at 9 months
measure: Exercise Self-Efficacy Scale
timeFrame: Change from Baseline at 9 months
measure: Exercise Decisional Balance Scale
timeFrame: Change from Baseline at 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01239927: Hartmann vs R/A in Peritonitis by Perforated Diverticulitis
Official title: Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peritonitis Caused by Perforated Left-sided Colon Diverticulitis
Keywords: diverticulitis
hartmann
anastomosis
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.


Eligibility criteria: Inclusion Criteria:

* Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria:

Primary outcomes:
measure: 30-day mortality and morbidity after emergency surgery
timeFrame: 30-day
Secondary outcomes:
measure: 30-day mortality and morbidity after elective restoration of intestinal transit
timeFrame: 30 day
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Gian Andrea Binda
Study officials:
affiliation: Division of Colon & Rectal Surgery State University of New York Stony Brook, New York
name: Roberto Bergamaschi, MD
role: STUDY_CHAIR
affiliation: EO Ospedali Galliera, Genova, Italy
name: Gian Andrea Binda
role: STUDY_DIRECTOR
affiliation: EO Ospedali Galliera, Genova, Italy
name: Alberto Serventi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06814873: Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity
Official title: Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatosensory Evoked Potentials, and Electroencephalography
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the functional and structural modification effects on the brain of a non-invasive experimental device applied to the head and forearms of healthy subjects during motor recall training. The experimental device used in this study is the Brain-Machine Interface (hereinafter referred to as BMI), which is under development in the principal investigator's laboratory. The BMI consists of an arithmetic unit that processes the results in real time using a personal computer, a depth ray that displays the results, a transcutaneous electrical stimulator that is driven based on the results of the arithmetic, and an exoskeletal motor assist device that is driven based on the results of the arithmetic.

Detailed description: This study does not fall under the category of 'medical research involving human subjects' or 'clinical research subject to legal regulations' in Japan, and the appointment of a principal investigator (PI) is not required. For the convenience of registry submission, the name of the principal investigator field has been filled with the name of the study representative (a non-physician).

Eligibility criteria: Exclusion Criteria:

* History of neurological disorder

Primary outcomes:
measure: Somatosensory evoked potential
timeFrame: From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.
Secondary outcomes:
measure: Touch typing performance
timeFrame: From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Keio University
state: Kanagawa
Study officials:
References: