louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06281028: SOLACEA-H in Heparin-sparing Haemodialysis
Official title: SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dialysis Membrane Reaction
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-02-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, multicenter, randomized
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU)

Detailed description: This is a randomised, crossover, open-label, prospective, multicentre post-marketing clinical follow-up study comparing two medical devices used (SOLACEA-H dialyser vs HYDROLINK-NVU dialyser) for their intended purpose.

Each patient will be followed for approximately 2 months, depending on the number of sessions in the anticoagulant reduction phase.

Patients will be offered the study by the investigator during a dialysis session as part of routine practice. If the patient accepts and signs the informed consent form, he or she will receive a succession of dialysis sessions including first the SOLACEA-H then the HYDROLINK-NVU membrane, or vice versa, depending on randomisation.

Eligibility criteria: Inclusion Criteria:

* On haemodialysis for at least 3 months
* Dialysis in a haemodialysis department of the Ramsay-Santé group
* No active infection
* Medically stable
* Blood flow ≥ 300 ml/min
* Haemoglobin level stable and within recommended norms for a dialysis patient, id est \> 10g/dl
* Bipunction
* No known allergy to SOLACEA H or HYDROLINK-NVU
* Willingness to comply with study procedures for the duration of the study
* For women of childbearing age: effective contraception, or absence of active pregnancy (negative pregnancy test)
* Member or beneficiary of a social security scheme
* Patient having been informed and having signed an informed consent form

Exclusion Criteria:

* Patient on oral anticoagulants for the duration of the study
* Patient on dialysate for the duration of the study
* Patient Medically unstable or fragile
* Severe hepatic impairment
* Patient hospitalised without consent
* Concurrent participation in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breast-feeding or parturient women
* Patient unable to receive heparin
* Known allergy to latex or phthalates

Primary outcomes:
measure: SOLACEA-H vs HYDROLINK-NVU efficacy
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Privé La Louvière
Study officials:
References:
Clinical trial NCT03474328: AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Official title: AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol-Related Disorders
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 60
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key therapeutic goal. However, there are no effective pharmacological therapies for maintaining abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol use, but is difficult to scale widely.

AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the app/breathalyser and changes in self-reported alcohol consumption.

Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of compatible smartphone. The exclusion criteria are: inability to provide consent. Participants will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use (units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored remotely).


Eligibility criteria: Inclusion Criteria:

* presence of ARLD
* age 18-70
* intent to maintain abstinence
* possession of compatible smartphone

Exclusion Criteria:

- inability to provide consent.

Primary outcomes:
measure: Self-reported alcohol consumption (average/week)
timeFrame: 3-month study period
Secondary outcomes:
measure: Compliance with the app (no. of logins, duration spent on the app)
timeFrame: 3-month study period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05828628: CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study
Official title: A Prospective Imaging and Translational Tissue Study in CNS Lymphoma to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CNS Lymphoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 36
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: Patients with newly diagnosed primary CNS lymphoma

Brief summary: A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.

Detailed description: As a single centre exploratory study, this trial will recruit patients with newly diagnosed primary CNS lymphoma and will look at the molecular aspects of the disease in the tissue collection and imaging response assessments using CCA with respect to progression free survival.

Eligibility criteria: Inclusion Criteria:

* Subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to CNS involvement, a consultee can provide consent on their behalf. Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with English or Scottish law as applicable (see 7.2.1)
* A radiological or histological diagnosis of primary CNS lymphoma.
* Have not received prior CNS directed therapy. Prior use of steroids is permitted.
* Participants aged ≥18 years old.

Exclusion Criteria:

- Involvement of lymphoma outside of the CNS

Primary outcomes:
measure: Plasma ctDNA detection
timeFrame: 5 Years
measure: Contrast clearance analysis
timeFrame: 5 Years
Secondary outcomes:
measure: Plasma ctDNA detection from end of treatment
timeFrame: 5 Years
measure: Plasma ctDNA detection rate at baseline
timeFrame: 5 Years
measure: Plasma ctDNA detection at end of treatment
timeFrame: 5 Years
measure: Plasma ctDNA detection rate at disease progression
timeFrame: 5 Years
measure: Radiological data provided by CCA
timeFrame: 5 Years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust, Downs Road
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Ian Chau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00327028: Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Phenytoin, Diphenine
Antiepileptic drugs
Efficacy
Lead sponsor: Centre of Chinese Medicine, Georgia
Sponsor class: OTHER
Collaborators: name: Rea Rehabilitation Centre, Georgia
First posted: 2006-05-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.

Detailed description: Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.

Eligibility criteria: Inclusion Criteria:

* Out patients
* Bronchial asthma has been known at least for 1 year
* Absence of long-term remissions of asthma (lasting more than 1 month)
* Poorly controlled asthma, due to various reasons
* Non-smokers

Exclusion Criteria:

* Presence of concomitant acute or chronic severe diseases
* Abnormal baseline haematology, blood chemistry or urinalysis
* Allergy or adverse reactions to investigational drug
* Age younger than 18 years old
* Long-term history of smoking
* Pregnancy or lactating

Primary outcomes:
measure: At 3 months of treatment
measure: Change from baseline of the PEFR and FEV1
measure: Number of patients without asthma symptoms
Secondary outcomes:
measure: At 3 months of treatment
measure: FEV1 before and after salbutamol inhalation
measure: The daily (daytime and night-time) symptoms scores
measure: Use of other antiasthmatic medication
Other outcomes:
Locations:
Study officials:
affiliation: CRO Evidence
name: Tamara Tchelidze, MD
role: STUDY_DIRECTOR
affiliation: Centre of Chinese Medicine
name: Manana Pruidze, MD, PhD
role: STUDY_CHAIR
affiliation: "Rea" Rehabilitation Centre
name: Merab Lomia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553028: Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery
Official title: Prospective Monocentric Randomized Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteosynthesis
Mazor Robot
Spinal Surgery
Arthrosis; Spine
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 300
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: Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel.

This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications.

Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful.

The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.


Eligibility criteria: Inclusion Criteria:

* Male, female, over 18 years old,
* Any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease),
* Patient having given his free, informed and written consent to participate in the study,
* Patient able to answer questionnaires, able to communicate in the language of the country of the study,
* Negative pregnancy test,
* Patient affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Minor,
* Psychological disorders,
* Addiction to analgesics,
* Chronic infection,
* History of instrumented lumbar surgery,
* BMI greater than or equal to 40kg/m²,
* Pregnant or breastfeeding woman,
* Patient participating in another clinical study,
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.

Primary outcomes:
measure: Evaluation of screw placement by a CT scan
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Clinique Saint Martin
Study officials:
References:
Clinical trial NCT00163228: Functional Evaluation of the Total Knee Prostheses:Rising From a Chair
Official title: Functional Evaluation of Total Knee Arthroplasties,Protocol for Rising From a Chair.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: C05.550.114.606.500
C05.550.114.606.508
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2005-09-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. At last, the TKA group will be compared to a THP group.


Eligibility criteria: Inclusion Criteria:

* unilateral TKA

Exclusion Criteria:

* TKA bilateral
* recent THP
* movement disorders like Parkinson's disease, insults, that disturb equilibrium and movements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: ORL, Radboud University Nijmegen Medical Centre
Study officials:
affiliation: ORL, Radboud University Nijmegen Medical Center
name: Nico Verdonschot, Phd
role: STUDY_CHAIR
affiliation: ORL, Radboud University Medical Centre
name: Maarten de Waal Malefijt, MD
role: STUDY_CHAIR
References:
citation: Boonstra MC, Schreurs BW, Verdonschot N. The sit-to-stand movement: differences in performance between patients after primary total hip arthroplasty and revision total hip arthroplasty with acetabular bone impaction grafting. Phys Ther. 2011 Apr;91(4):547-54. doi: 10.2522/ptj.20090376. Epub 2011 Feb 24.
citation: Boonstra MC, Schwering PJ, De Waal Malefijt MC, Verdonschot N. Sit-to-stand movement as a performance-based measure for patients with total knee arthroplasty. Phys Ther. 2010 Feb;90(2):149-56. doi: 10.2522/ptj.20090119. Epub 2009 Dec 10.
Clinical trial NCT01698528: Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Official title: Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes
Keywords: Diabetes
diabetes technologies
telemedicine
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2012-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.


Eligibility criteria: Inclusion:

* 18 years or older
* Has type 2 diabetes, starting on basal insulin therapy
* Hemoglobin A1c between 9-14%
* Has Wi-Fi internet connection at home
* Is willing to monitor blood glucose at least once per day
* Is willing to inject and self-titrate insulin dose
* Able to read and communicate in English proficiently

Exclusion:

* Has severe visual impairment impacting visual acuity
* Has severe hearing impairment impacting communication
* Has Type 1 diabetes
* Pregnant or lactating women
* Alcohol dependency
* Require multiple daily insulin injections

Primary outcomes:
measure: Glycemic Control as Determined by the Change in Absolute HbA1c Level
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants Reaching Target of HbA1c ≤ 7%
timeFrame: 3 months
measure: Change in Average Participation Satisfaction
timeFrame: 3 months
measure: Number of Participants With Hypoglycemia
timeFrame: 3 months
measure: Time Health Care Providers and Subjects Spend on Managing the Insulin Titration
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: William Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491228: Anaemetro I.V. Infusion 500mg Drug Use Investigation
Official title: METRONIDAZOLE IV DRUG USE INVESTIGATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaerobic Infection
Infectious Enterocolitis
Amebic Dysentery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-04-09
Enrollment: 107
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who satisfy all of the inclusion criteria are subject to this study.

Brief summary: Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice


Eligibility criteria: Inclusion Criteria:

* Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.

Exclusion Criteria:

* No exclusion criteria are set out in this study.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reaction (ADR)
timeFrame: Maximum 8 weeks
Secondary outcomes:
measure: Clinical Response Rate
timeFrame: Maximum 8 weeks
measure: Clinical Response Rates by Target Diseases
timeFrame: Maximum 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01103193: Nitrous Oxide - Sevoflurane-Remifentanil Interaction
Official title: Nitrous Oxide - Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia
Keywords: ASA class I/II patients, with surgery under general anesthesia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: patients are allocated to one of the two study groups.

In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.

During the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.

The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia class I and II patients
* aged 18-60 years
* scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* neurological disorder
* diseases involving the cardiovascular system, pulmonary disease, gastric diseases, endocrinological diseases
* recent use of psycho-active medication, including alcohol

Primary outcomes:
measure: To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil
timeFrame: Every 12 minutes during induction and maintenance of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo Vereecke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: