louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02408627: EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Pilipili NV
name: Imec
First posted: 2015-04-03
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.

Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.

Minimum 2 - maximum 10 epilepsy patients will be included.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.


Eligibility criteria: Inclusion Criteria:

* Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG

Exclusion Criteria:

* Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG

Primary outcomes:
measure: EEG signal quality (visual and clinical) (scale)
timeFrame: 10 minutes
measure: EEG signal quality (technical) (signal to noise ratio)
timeFrame: 10 minutes
measure: User experience (questionnaire)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT04218227: Dropout Factors in Chronic Pain Management
Official title: Dropout Factors in Chronic Pain Management : What Are the Predictors ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have had a chronic pain diagnosis (all body-parts and all type of pain included) and must have been included in one of the outpatient chronic pain non-pharmacological management programme with an interdisciplinary approach proper to our pain department at the Hospital University of Liège (Belgium).

Brief summary: Chronic pain concernes one in four adults in Belgium. Because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life chronic pain patients. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. However, a major problem in clinical research is patient dropout. To our knowledge, no study has investigated dropout rates in hypnosis clinical research. The aim of this study is, therefore, to better understand the predictors of dropout in several non-pharmacological treatments in chronic pain management.


Eligibility criteria: Inclusion Criteria:

* Major
* Fluency in French
* Chronic pain diagnosis

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism

Primary outcomes:
measure: Amount of drop-out
timeFrame: T1 (before treatment)
measure: Amount of dropout between treatment groups
timeFrame: T1 (before treatment)
measure: Influence of therapist's expertise in hypnosis
timeFrame: T1 (before treatment)
measure: Link between state-financial help and drop-out
timeFrame: T1 (before treatment)
measure: Influence of motivation
timeFrame: T1 (before treatment)
measure: Influence of pain description
timeFrame: T1 (before treatment)
measure: Influence of sleep difficulties
timeFrame: T1 (before treatment)
measure: Influence of insomnia
timeFrame: T1 (before treatment)
measure: Influence of anxiety
timeFrame: T1 (before treatment)
measure: Influence of depression
timeFrame: T1 (before treatment)
measure: Influence of pain disability
timeFrame: T1 (before treatment)
measure: Influence of the impact of pain
timeFrame: T1 (before treatment)
measure: Influence of attitudes and beliefs about pain
timeFrame: T1 (before treatment)
measure: Influence of quality of life
timeFrame: T1 (before treatment)
measure: Influence of locus of control
timeFrame: T1 (before treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Hospital University of Liège
Study officials:
References:
Clinical trial NCT01148927: Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia
Official title: A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term survivors of adult acute lymphoblastic leukemia treated with modified Dana Farber Cancer Institute ALL protocol (91-01).

Brief summary: Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.

This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:

* EORTC QLQ C30 to assess global health and major health domains
* Brief Pain Inventory (BPI)
* Personal Health Questionnaire (PHQ9) to assess psychosocial distress
* Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire
* Peripheral Neuropathy Questionnaire

The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.


Eligibility criteria: Inclusion Criteria:

* previously diagnosed with adult ALL or T-lymphoblastic lymphoma
* Age \>/= 18
* Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
* Understand English and are able to fill out questionnaires

Primary outcomes:
measure: To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Joseph M Brandwein, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912027: Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Instability
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 30
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: The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.


Eligibility criteria: Inclusion Criteria:

* age older than 15 years
* Traumatic anterior shoulder instability
* Recurrent instability
* Glenoid defects larger than 25%
* Clinical and radiographic data at pre-operation and follow-up

Exclusion Criteria:

* Younger than 18 years
* Non-traumatic shoulder instability
* Primary episode of instability
* Glenoid defects less than 25%
* Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear

Primary outcomes:
measure: The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film .
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijng
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospitial
name: Chunyan Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229827: Optimal Timing for Repair of Left to Right Shunt Lesions
Official title: Optimal Timing for Repair of Left-to-Right Shunt Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventricular Septal Defects
Persistent Common Atrioventricular Canal
Keywords: pediatric health
cardiac
pediatric population
congenital heart surgery
left to right shunt lesions
heart surgery
Atrioventricular canal defects
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the congenital surgery database

* Patients who have undergone repair of ventricular septal defects
* Patients who have undergone repair of atrioventricular canal defects

Brief summary: The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.

Detailed description: In the past, children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band. This prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements. The primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals. The secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy. This study will be conducted through a retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* Patients in the congenital surgery database
* Patients who have undergone repair of ventricular septal defects
* Patients who have undergone repair of atrioventricular canal defects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562627: Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Official title: Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee arthroplasty
local infiltration analgesia
TKA
epidural analgesia
operation
surgery
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2007-11-22
Enrollment: 102
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: Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Detailed description: Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Eligibility criteria: Inclusion Criteria:

* patients at least 18 years of age
* scheduled for elective total knee arthroplasty
* ASA I-III
* signed written informed consent

Exclusion Criteria:

* age \< 18
* ASA \> III
* moderate or severe cardiac disease, bronchial asthma
* allergy against ropivacaine, ketorolac or morphine
* analgetic abuse
* pregnancy or nursing women
* severe psychiatric disease
* moderate to severe dementia

Primary outcomes:
measure: Pain at Rest (VAS)
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Opioid Use
timeFrame: 48 hours postoperative
measure: Time to Readiness for Discharge
timeFrame: up to 10 days postoperative
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Asker and Baerum Hospital
Study officials:
affiliation: Asker and Baerum Hospital
name: Ulrich J Spreng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.
Clinical trial NCT02304627: Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Official title: Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Age 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as informed consent
* Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

Primary outcomes:
measure: Area under the serum insulin 338 concentration-time curve
timeFrame: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points
Secondary outcomes:
measure: Area under the serum insulin 338 concentration-time curve
timeFrame: From 0 to 288 hours after a single dose (SD)
measure: Maximum observed serum insulin 338 concentration
timeFrame: From 0 to 288 hours after a single dose (SD)
measure: Area under the plasma capric acid concentration-time curve
timeFrame: From 0 to 24 hours after a single dose
measure: Maximum observed plasma capric acid concentration
timeFrame: From 0 to 24 hours after a single dose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2.
Clinical trial NCT04463927: The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
Official title: The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity.

Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

Detailed description: A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity

Eligibility criteria: Inclusion Criteria:

* having an examination for retinopathy of prematurity for the first time,
* age was between 28-35 weeks

Exclusion Criteria:

- having no congenital anomalies

Primary outcomes:
measure: Premature Infant Pain Profile
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University
Study officials:
affiliation: Adiyaman University
name: Tuba KOÇ ÖZKAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01787227: A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel
Official title: A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infection
Bronchitis
Bronchiolitis
Pneumonia
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical specimens collected from patients with clinical signs and symptoms of respiratory tract infection who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.

Brief summary: xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).

The objective of this study is to establish diagnostic accuracy of the xTAG RPP.


Eligibility criteria: Inclusion Criteria:

* The specimen is a nasopharyngeal swab.
* The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
* The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.

Exclusion Criteria:

* The specimen is not a nasopharyngeal swab.
* The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Primary outcomes:
measure: Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
timeFrame: Within the first year after sample extraction
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Lake Success
country: United States
facility: North Shore-LIJ Health System Laboratories
state: New York
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: Luminex Molecular Diagnostics
name: Jeremy Liu, Ph.D
role: STUDY_DIRECTOR
affiliation: St. Joseph's Health Care London
name: James Mahony, Ph.D, FCCM, FAAM
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis Children's Hospital
name: Richard Buller, PhD, D (ABMM)
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott and White Hospital & Clinic
name: Arundhati Rao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore-LIJ Health System Laboratories, NY
name: Christine Ginocchio, Ph.D., M.T.(A.S.C.P.)
role: PRINCIPAL_INVESTIGATOR
References: