louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02934646: Powered Exoskeleton for the Treatment of Elbow Spasticity
Official title: Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Spasticity
Stroke
Keywords: Robotics
Upper Extremity
Lead sponsor: Auxilium Vitae Volterra
Sponsor class: OTHER
Collaborators: name: Azienda USL Toscana Nord Ovest
name: Scuola Superiore Sant'Anna di Pisa
First posted: 2016-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.

Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.


Eligibility criteria: Inclusion Criteria:

1. Upper limb spasticity due to neurological impairment;
2. Cognitive abilities sufficient for understanding instructions;
3. Absence of severe pain assessed as Visual Analogic Score (VAS) \< 4 (range 0-10).

Exclusion Criteria:

1. Unstable general clinical conditions;
2. Unability to keep sitting posture;
3. Tendon retractions limiting upper limb joints range of motion.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Range of Motion
timeFrame: 2 weeks
measure: Maximum Extension Torque
timeFrame: 2 weeks
measure: Zero-Torque Angle
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01418846: Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients
Official title: Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumology
Hematology
Internal Medicine
Pediatrics
Keywords: voriconazole
saliva
pharmacokinetics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at the pneumology ward, adult hematology ward and all hospitalized pediatric patients, treated with voriconazole.

Brief summary: The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.


Eligibility criteria: Inclusion Criteria:

* patients from the adult hematology ward treated with voriconazole
* pediatric patients treated with voriconazole, age 5-18 years
* patients from the pneumology ward treated with voriconazole

Exclusion Criteria:

* Age under 5 years
* Women who are pregnant or lactating
* Mucositis stage 3 or 4 (WHO)
* Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates.
* Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.

Primary outcomes:
measure: Voriconazole pharmacokinetics in saliva and plasma in different patient populations
timeFrame: One day at steady state of voriconazole plasma levels
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Cystic Fibrosis Clinic
state: East Flanders
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
city: Brussels
country: Belgium
facility: University Hospital Brussels - Cystic Fibrosis Clinic
Study officials:
affiliation: Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
name: Kim Vanstraelen, R.Ph.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184246: The Depth of Endotracheal Tube Insertion
Official title: The Depth of Endotracheal Tube Insertion - Use of Direct Laryngoscopy and Videolaryngoscopy (GlideScope), Comparison of Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Keywords: Videolaryngoscopy (GlideScope)
Direct laryngoscopy
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional group will be intubated by videolaryngoscopy, control group by direct laryngoscopy
Primary purpose: PREVENTION

Brief summary: The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.

Detailed description: 100 patients scheduled for elective neurosurgical procedures will be randomized into two groups. Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used. Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0). Sufentanil will be used to block tracheal reflexes. In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation. Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I - III

Exclusion Criteria:

* postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction

Primary outcomes:
measure: the depth of primary insertion of tracheal tube
timeFrame: in a minute after intubation
Secondary outcomes:
measure: sums of manipulation with tracheal tube
timeFrame: 2 minutes after intubation
measure: complications after intubation
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Pavel Dostal, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03900546: Arterial Tone Influence on Cardiac Output Measured by PRAM
Official title: Influence of Arterial Tone Changes on Cardiac Output Measurement by Pressure Recording Analytical Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Critically Ill
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.

Brief summary: This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.

Detailed description: Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.

Eligibility criteria: Inclusion Criteria:

* invasive blood pressure monitoring on site
* need to start or change the dose of noradrenaline infusion for clinical reason

Exclusion Criteria:

* age \<18
* arrhythmia
* severe valvular insufficiency
* pregnancy
* low quality arterial signal

Primary outcomes:
measure: Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM
timeFrame: Before and 30 minutes after noradrenaline dose variation
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Study officials:
affiliation: Università Politecnica delle Marche
name: Abele Donati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04051346: Dietary Oxalate and Innate Immunity in Kidney Stone Disease
Official title: Dietary Oxalate and Innate Immunity in Kidney Stone Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: dietary oxalate
diet therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate).

Detailed description: Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects (men and women) between the ages of 18 and 60 years of age
* No calcium oxalate kidney stones or other medical conditions
* Normal comprehensive metabolic panel (CMP)
* Non tobacco users
* Not pregnant
* BMI between 20-30 kg/m2
* Willing to abstain from vigorous exercise and vitamins/supplements during the study
* Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn

Exclusion Criteria:

* Inability to sign and read the informed consent
* Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements
* Physician refusal
* Pregnant women
* Active medical problems
* History of kidney stones or any medical condition that could influence absorption or excretion of oxalate
* Tobacco users
* Taking medications or dietary supplements
* BMI \>30 or \<20

Primary outcomes:
measure: Change in Urinary Oxalate
timeFrame: Days 3-4 and 13-14
measure: Change in Crystalluria
timeFrame: Days 3-4 and 13-14
measure: Change in Monocyte Cellular Energetics and Mitochondrial Function
timeFrame: Days 1, 4, 11, and 14
measure: Change in Monocyte Subtypes
timeFrame: Days 1, 4, 11, and 14
measure: Change in Monocyte Transcriptomics
timeFrame: Days 1, 4, 11, and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tanecia Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154946: Clinical Implication of DAC (Detrusor After-contraction)
Official title: A New Approach to Clinical Implication of Detrusor After-contraction (DAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voiding Dysfunction
Keywords: detrusor after-contraction
urodynamic
LUTS
urinary bladder, overactive
bladder dysfunction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 2309
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: 2,309 patients more than 18 years old with neurogenic or non-neurogenic voiding dysfunction who performed urodynamic studies

Brief summary: The aims of this study are

* to confirm whether detrusor after-contraction (DAC) is a true contraction or not with a new approach
* and to understand clinical implication of DAC

Detailed description: The definition of detrusor after-contraction (DAC) is usually accepted as the increase of detrusor pressure (Pdet), whether it is sudden or not, after cessation of urinary flow. The amount of increase in Pdet is sometimes included in the definition of DAC (14, 15, 20 cmH2O or at least two times the level of the maximal Pdet during the voiding phase). However, it is clear that the lack of a well-established definition may induce much bias in the interpretation of the clinical implication of DAC. The previous studies showed a wide range of prevalence.1-4 DAC seemed to occur more frequently in children and the occurrence rate usually decreased with age in urodynamic studies.

Eligibility criteria: Inclusion Criteria:

* Indications and selection of patients for conduction of urodynamic studies (UDS) were followed as the recommendation of ICS (international continence society).

Exclusion Criteria:

* Patients with indwelling catheters, urinary tract infection and urinary stones were excluded from this study

Primary outcomes:
measure: to confirm whether DAC is a true contraction or not
timeFrame: up to 2 years (2007.Jan-2008.Dec)
Secondary outcomes:
measure: Past medical history including neurological disorders and pelvic irradiation were also included in the database
timeFrame: up to 2 years (2007.Jan-2008.Dec)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seung-June Oh, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruarte AC, Podesta ML, Medel R. Detrusor after-contractions in children with normal urinary tracts. BJU Int. 2002 Aug;90(3):286-93. doi: 10.1046/j.1464-410x.2002.02827.x.
Clinical trial NCT06339346: Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection
Official title: Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Colorectal Adenocarcinoma
Keywords: colorectal cancer
pathological risk factors
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pT1 colorectal cancer (of adenocarcinoma subtype only) diagnosed from January the 1st, 2009 to December the 31st, 2020, with first endoscopic resection, in the area of Finistère (France)

Brief summary: Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.

Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.

It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.

The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients with pT1 colorectal cancer (of adenocarcinoma subtype only) diagnosed from January the 1st, 2009 to December the 31st, 2020, with first endoscopic resection, in the area of Finistère (France)

Exclusion Criteria:

* other than adenocarcinoma
* other than T1
* primary surgical management
* neoadjuvant treatment
* refusal to data collection

Primary outcomes:
measure: Analysis of lymph node invasion rates as a function of tumor characteristics
timeFrame: 10 years
Secondary outcomes:
measure: Population demographics
timeFrame: 10 years
measure: lesion characteristics
timeFrame: 10 years
measure: management
timeFrame: 10 years
measure: recurrence
timeFrame: 10 years
measure: survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT03627546: HCV Seek, Test and Rapid Treatment for Young PWID
Official title: A Randomized Study of a Rapid HCV Treatment Initiation Strategy (HCV Seek, Test and Rapid Treatment) Compared to Standard Care in Young People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Drug Use
Keywords: PWID
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-08-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment

Detailed description: ST\&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).

Eligibility criteria: Inclusion Criteria:

* Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking

Exclusion Criteria:

* Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir

Primary outcomes:
measure: The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care
timeFrame: Week 48
Secondary outcomes:
measure: The Proportion of Participants Who Initiate Treatment for HCV
timeFrame: Week 48
measure: Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure
timeFrame: 48 wks
measure: Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48
timeFrame: 48 wks
measure: Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
timeFrame: Baseline and 48 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Lower East Side Harm Reduction Center
state: New York
Study officials:
affiliation: Weill Cornell MC
name: Kristen Marks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260046: Effect of Sufentanil on the Postoperative Pain
Official title: Analgesic Effect of Intraoperative Sufentanil on Postoperative Pain in Patients Undergoing Robot-assisted Nephrectomy: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo elective robot-assisted nephrectomy surgery
* American Society of Anesthesiologists grade 1,2,3
* Age \> 18 years old

Exclusion Criteria:

* Refuse to participate to the study
* Allergic history of opioid
* chronic pain
* opioid user before surgery
* MAO inhibitor user
* Severe respiratory insufficiency

Primary outcomes:
measure: opioid consumption
timeFrame: During post-anesthesia care unit(PACU) stay, until 1 hour
Secondary outcomes:
measure: Richmond Agitation-Sedation scale
timeFrame: During post-anesthesia care unit(PACU) stay, until 1 hour
measure: Incidence of postoperative nausea and vomiting
timeFrame: During post-anesthesia care unit(PACU) stay, until 1 hour
measure: Number of patients who administered antiemetics
timeFrame: During post-anesthesia care unit(PACU) stay, until 1 hour
measure: Pain score
timeFrame: immediately after surgery, 15minutes, 30minutes, 60minutes after surgery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References: