louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01662141: Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
Official title: Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Cardiac Surgery
Keywords: Cardiac output
Perivascular Probe
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 33
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Patients (\< 15) in the ICU

Brief summary: The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

Detailed description: The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.

COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.

Eligibility criteria: Inclusion Criteria:

* Children \<15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

Exclusion Criteria:

* Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
* Children with persistent severe arrhythmias.
* Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.

Primary outcomes:
measure: Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.
timeFrame: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Children Hospital, BUS, BIVA
Study officials:
affiliation: University Hospital in Lund
name: Lars Lindberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
Clinical trial NCT00436241: A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
Official title: A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* gastric cancer with unresectable locally advanced and/or metastatic disease;
* \>=1 measurable lesion;
* ambulatory, with ECOG Performance Status \>=1.

Exclusion Criteria:

* previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to enrollment);
* clinically significant cardiac disease or myocardial infarction within last 12 months;
* CNS metastases;
* history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.

Primary outcomes:
measure: Overall response rate
timeFrame: Event driven
Secondary outcomes:
measure: Time to disease progression, overall survival, duration of response, time to response.
timeFrame: Event driven
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Chai Yi
country: Taiwan
city: Chai Yi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Keelung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Yilan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04873141: Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia
Official title: Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia: Experience From Single Center of Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytokine Release Syndrome
Covid-19 Pneumonia
Keywords: Cytokine Release Syndrome
Covid-19 Pneumonia
Tocilizumab
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 24
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 of age (18-all) and suffering from COVID- 19 severe pneumonia

Brief summary: Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients.

Detailed description: This observational study was designed just to visualize the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers.Patients will be followed until Day 29 after randomization.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP, D-Dimers or ferritin levels; Bodyweight ≥ 40kg.

Exclusion Criteria:

* Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; Use of tocilizumab within 3 weeks prior; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC \<1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.

Primary outcomes:
measure: Mortality Rate
timeFrame: 28 days
measure: Time to discharge
timeFrame: 28 days
Secondary outcomes:
measure: Laboratory parameters
timeFrame: 30 days
measure: Oxygen Saturation
timeFrame: 30 days
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Muhammad Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03503617: RehabTouch Home Therapy for Stroke Patients
Official title: RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Lead sponsor: Flint Rehabilitation Devices, LLC
Sponsor class: INDUSTRY
Collaborators: name: Rancho Research Institute, Inc.
First posted: 2018-04-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 85 years old
* Upper extremity weakness measured by a clinical scale
* Absence of moderate to severe pain on affected upper extremity
* Able to understand the instructions to operate RehabTouch

Exclusion Criteria:

* Concurrent severe medical problems, visual deficits, severe neglect or apraxia
* Enrollment to other therapy studies

Primary outcomes:
measure: Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
timeFrame: From Baseline to One-month Post-therapy
Secondary outcomes:
measure: Change in Box and Blocks Test Score
timeFrame: From Baseline to One-month Post-therapy
measure: 10 Meter Walk Test
timeFrame: From Baseline to One-month Post-therapy
measure: Motor Activity Log
timeFrame: One-month Post-therapy
measure: Visual Analog Pain Scale
timeFrame: From Baseline to One-month Post-therapy
measure: Modified Ashworth Spasticity Scale
timeFrame: From Baseline to One-month Post-therapy
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute, Inc.
state: California
Study officials:
affiliation: Rancho Research Institute, Inc.
name: Susan Shaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497417: A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
Official title: A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Infectious Colitis
Keywords: ARIES Clostridium difficile
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 1021
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: All comers

Brief summary: The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.

Detailed description: The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD).

The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility criteria: Inclusion Criteria:

* The specimen is from a patient suspected of having C. difficile associated disease (CDAD).
* The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria:

* The specimen is preserved.
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.

Primary outcomes:
measure: Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
timeFrame: Within the first year of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Albuquerque
country: United States
facility: TriCore Reference Laboratories
state: New Mexico
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Luminex Corporation
name: Ronald Dunn
role: STUDY_DIRECTOR
References:
Clinical trial NCT00213317: Effect of Lumbo-sacral Magnetic Stimulation on Colonic Motility
Official title: Could Lumbo-sacral Magnetic Stimulation Modify Recto-colonic Motility?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Colonic Disease
Fecal Incontinence
Keywords: sacral magnetic stimulation
fecal incontinence
constipation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers without anorectal or neurological disease

Brief summary: The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients.


Eligibility criteria: Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

pregnant women metallic material implanted organic digestive disease neuro-surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Anne-Marie LEROI, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06389617: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block
Official title: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block for Creation of Arteriovenous Fistula in End Stage Renal Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Renal Failure
Lead sponsor: Hospital Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant


Eligibility criteria: Inclusion Criteria:

Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation

Exclusion Criteria:

Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/

Primary outcomes:
measure: To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
timeFrame: 2 days
measure: To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg
timeFrame: 2 days
Secondary outcomes:
measure: To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00819117: Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
Official title: INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Epicardial leads
Cardiac Resynchronization Therapy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

Detailed description: This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.

After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:

* Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
* Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).

All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.

Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Eligibility criteria: Inclusion Criteria:

* Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
* Have a stable pharmacological therapy.

Exclusion Criteria:

* Have a contra-indication to general anesthesia;
* Have a scheduled cardiac surgery;
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
* Have a life expectancy of less than 6 months;
* Are unable to provide informed consent;
* Are unable to comply with the follow-up schedule and tests;
* Are minor (age below 18 years);
* Are pregnant or are planning for pregnancy in the next 6 months.

Primary outcomes:
measure: The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
timeFrame: 6 months follow up after implant
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Torino
country: Italy
facility: Azienda Sanitaria Osperaliera Ordine Mauriziano
Study officials:
affiliation: Ospedale Cisanello, Pisa, Italy
name: Maria Grazia Bongiorni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222217: Gatekeeper for Soiling and Gas Incontinence
Official title: Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gas Incontinence
Soilings, Fecal
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients' selection was based on clinical history, physical examination, preoperative 3D-endoanal ultrasound (EUS) and a continence diary recorded for 21 days. Patients with previous history of chronic diarrhoea were evaluated by the gastroenterology team and if needed, fibre supplementation or other medical treatment was used to obtain a Bristol score of 3-4 before entering the study

Brief summary: Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined.

The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before.

Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses


Eligibility criteria: Inclusion Criteria:

* patients older than 18 years old
* with at least 6 months of GI and/or soiling
* non-responding to conservative treatment and biofeedback.

Exclusion Criteria:

* complete solid and liquid FI
* common Bristol score \> 4
* malignant diseases
* chronic diarrhoea
* inflammatory bowel disease
* acute anorectal disease
* rectal prolapse
* neurological disease,
* obstructive defecation syndrome
* low anterior resection syndrome,
* previous pelvic radiation,
* any anaesthetic contraindication
* St. Mark's score \> 12
* external anal sphincter lesion \> 30º.

Primary outcomes:
measure: Change in the number of gas incontinence and soiling episodes
timeFrame: 6, 12 and 24 months after surgery
measure: Changes in incontinence symptoms
timeFrame: 6, 12 and 24 months after surgery
measure: Patient's Subjective Perception
timeFrame: 6, 12 and 24 months after surgery
Secondary outcomes:
measure: Changes in prostheses location
timeFrame: baseline and one month after surgery
measure: Differences in anal pressures
timeFrame: baseline and three months after surgery
Other outcomes:
Locations:
Study officials:
References: