louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02431663: Ketamine in Refractory Convulsive Status Epilepticus
Official title: Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Status Epilepticus
Keywords: refractory convulsive status epilepticus
ketamine
conventional anesthetics
children
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: Ospedali Riuniti Ancona
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: University of Padova
name: Bambino Gesù Hospital and Research Institute
name: Catholic University of the Sacred Heart
name: IRCCS Burlo Garofolo
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Nuovo Regina Margherita Hospital
name: Vittore Buzzi Children's Hospital
First posted: 2015-05-01
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.


Eligibility criteria: Inclusion Criteria:

* Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
* Refractoriness of the drug I and II line
* Written informed consent from parents or legal guardian.
* Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.

Exclusion Criteria:

* contraindications to the use of the medication/s in the study.
* pregnant or suspected pregnant.

Primary outcomes:
measure: Number of participants with resolution of refractory convulsive status epilepticus
timeFrame: participant wil be followed for 24 hours after discontinuation of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Anna Rosati
Study officials:
affiliation: Children's Hospital A. Meyer of Firenze, Italy
name: Anna Rosati, MD, PhD
role: STUDY_CHAIR
References:
citation: Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6.
citation: Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565.
Clinical trial NCT05415163: Vascular Photobiomodulation on Sleep Qualityand Stress
Official title: Effect of Vascular Photobiomodulation on Sleep Quality, Relaxation and Stress Control: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorder
Sleep Disorder
Keywords: stress
sleep disorder
photobiomodulation
laser therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to evaluate the effect of vascular photobiomodulation on sleep quality, relaxation and stress when compared to placebo.

Detailed description: The quality of sleep is directly linked to the quality of human life. Irradiation of blood in the transcutaneous vascular technique is believed to decrease blood viscosity and platelet aggregation; activates superoxide dismutase; promotes increased oxygen content and stimulates microcirculation, it also stimulates increased serotonin production and cortisol reduction. Serotonin functions include sleep initiation, mood improvement, anxiety and depression. Therefore, the objective of the present project is to evaluate the effect of ILIB on salivary biomarkers related to stress and sleep. Therefore, participants with problems related to sleep quality will be selected and divided into 2 groups, group 1 undergoing ILIB Therapy twice a week for 30 minutes and group 2 the same frequency and time of application, but with placebo equipment. At the end of 10 sessions, salivary biomarkers related to stress and sleep and the patients' perception will be evaluated through specific questionnaires on the effect of ILIB on sleep, stress and relaxation.

Eligibility criteria: Inclusion Criteria:

* poor sleep quality.
* Participants who for at least six months have had poor sleep quality (score \> 5 points), measured using the PSQI,

Exclusion Criteria:

* use medications or perform treatments that may affect the sleep cycle
* treatment for hypertension
* asthma,
* attention deficit disorder,
* diabetes.

Primary outcomes:
measure: Quality of sleep
timeFrame: five weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Roque
country: Brazil
facility: Lara Motta
state: SP
Study officials:
References:
Clinical trial NCT02858063: Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
Official title: Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Quality Of Life
Women
Partner
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Université Lille 3
First posted: 2016-08-08
Enrollment: 1045
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women (\<45 years old)treated or previously treated by chemotherapy for a non metastatic breast cancer, in Relationship for at least 6 months

Brief summary: * Selection of patient and preparation of questionnaires
* Presentation of the study by the doctor
* Verbal consent of participants (patient and Partner)
* Delivery of booklets
* Response to documents (questionnaires and written consent) at home, send by mail

Detailed description: 1. Before consultation :

   Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file
2. During the consultation :

   * Presentation of the study by the investigator
   * The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes
   * Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)
3. At home :

   * Signature of the information note and the participation consent form
   * Patients and Partner responds to their questionnaire (including socio-demographique questionnaire)
   * They send the documents thanks to stamped envelopes:

     1. They send information note to the medical center
     2. They send the questionnaires to the university

Eligibility criteria: Inclusion Criteria:

* \>18 years old (patient and partner)
* \<45 years old (patient)
* Patient with a non metastatic breast cancer
* Patient treated or previously treated by chemotherapy
* Patient and her Partner live together for at least 6 months when they complete the questionnaires.

Exclusion Criteria:

* Patient or patner with psychiatric trouble
* Native language other than french

Primary outcomes:
measure: psychometric validation of a questionnaire in Young patients and their partners
timeFrame: 1 year
Secondary outcomes:
measure: compare convergent and or divergent dimensions with patients and theirs partners
timeFrame: 1 year
measure: compare responses of participants according to traitement/ surveillance period
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04542863: The Molecular Imaging Research of F-18 Labeled DX600 PET Probe
Official title: The Molecular Imaging Research of F-18 Labeled DX600 PET Probe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.


Eligibility criteria: Inclusion Criteria:

* Age \>3 years old; both sex;
* ECoG 0 or 1;
* Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
* use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Is Pregnant or ready to pregnant;
* Cannot lie on their back for half an hour;
* Suffering from claustrophobia or other mental diseases;
* Refusal to join the clinical study;

Primary outcomes:
measure: Standard uptake value (SUV)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03331263: Single Dose CHG Pharmacokinetic Study
Official title: Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgical Skin Preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.


Eligibility criteria: Inclusion Criteria:

* Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:

  * non- or ex-smokers
  * body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
  * negative pregnancy test for female subjects
  * healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)

Primary outcomes:
measure: Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
timeFrame: Up to 24 hours after product application
Secondary outcomes:
measure: Number of Subjects With of Treatment Emergent Adverse Events.
timeFrame: Up to 24 hours after product application, overall, up to 3 weeks
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Algorithme Pharma USA LLC
state: North Dakota
Study officials:
affiliation: Algorithme Pharma USA LLC
name: James Carlson, Pharm D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165863: Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement
Official title: Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Disease
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.


Eligibility criteria: Inclusion Criteria:

* Males or females undergoing a total knee prosthesis.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* Hb \> 11 g/dl; Platelet value \> 150.000 plt/mmc;
* Patients with non clinical alteration of ECG;
* Signature of informed consent;

Exclusion Criteria:

* Patients incapable of understanding and of wanting;
* Systemic disorders such as diabetes, rheumatic diseases;
* Patients with malignancy;
* Thyroid metabolic disorders ;
* Abuse of alcohol, drugs and pharmaceutical drugs
* Body mass index \> 40;

Primary outcomes:
measure: clinical improvement of the healing process
timeFrame: 2 weeks
Secondary outcomes:
measure: Dermatology life quality
timeFrame: 3 days, 15 days and 1 month
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Harato K, Tanikawa H, Morishige Y, Kaneda K, Niki Y. What are the important surgical factors affecting the wound healing after primary total knee arthroplasty? J Orthop Surg Res. 2016 Jan 13;11:7. doi: 10.1186/s13018-016-0340-y.
citation: Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am. 2009 Jan;91(1):48-54. doi: 10.2106/JBJS.G.01371.
citation: Rui M, Zheng X, Sun SS, Li CY, Zhang XC, Guo KJ, Zhao FC, Pang Y. A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery. Hip Int. 2018 Jan;28(1):101-105. doi: 10.5301/hipint.5000534.
Clinical trial NCT00836563: Vascular Changes Following Forearm Loop Arteriovenous Graft Placement
Official title: The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Hemodialysis
Arteriovenous Graft
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing forearm arteriovenous loop graft placement

Brief summary: This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.

Detailed description: The purpose of this study is to determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement, and if they do, characterize the timing of these changes.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 19 years
2. Planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days.
3. Cephalic and/or basilic vein diameter greater than or equal to 2.5 mm at the antecubital fossa to the axilla prior to AVG placement

Exclusion Criteria:

1. Age less than 19 years
2. Hemodialysis access other than forearm loop graft surgery placement
3. Cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla
4. Prior hemodialysis access surgery in the arm receiving the forearm loop graft

Primary outcomes:
measure: Upper arm vein diameter
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center/The Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Troy J Plumb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356363: Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs)
Official title: Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: Oncology
oncology care pathway
patients' perception
questionnaire
psychometric validation
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
Collaborators: name: Université de Reims Champagne-Ardenne
First posted: 2024-04-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with cancer regardless of location or stage.

Brief summary: Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.

PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.

In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge.

Detailed description: The aims of the study are to constitute a questionnaire to assess patients' perceptions of their oncology care pathway and to perform its psychometric validation.

Eligibility criteria: Inclusion Criteria:

* cancer patient
* regardless of location or stage
* Fluent in French
* aged more than 18 years old
* Agreeing to take part in the study

Exclusion Criteria:

* With an estimated life expectancy of less than 3 months
* In remission, untreated or without follow-up for more than 12 months
* Protected by law

Primary outcomes:
measure: Psychometric validation
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Godinot
name: DIOURI Loubna
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167735: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. While listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. Participants are asked to repeat back the sentences loud. At fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. Two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. The same conditions will be re-tested once after a minimum of one day. A pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Mild-Moderate/Severe (N2-N4) hearing loss

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Changes in Event-related-pupil-dilations (ERPDs)
timeFrame: 4 weeks
Secondary outcomes:
measure: Oldenburg sentence test
timeFrame: 4 weeks
measure: subjective rating
timeFrame: 4 weeks
Other outcomes:
measure: Non-verbal Trail Making Test A & B
timeFrame: 1 week
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References: