louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01642459: The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.
Official title: The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Fistula
Keywords: arteriovenous fistula
hemodialysis
aneurysm
vascular stenosis
cannulation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 10
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: PREVENTION

Brief summary: The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.

Detailed description: Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.

Eligibility criteria: Inclusion Criteria:

* MHD patients with autogenous AVF.
* Newly setup AVF in 3 months.
* Fore- or Upper arm AVF.
* Flow of \>800ml/min detected by using the ultrasound dilution technique.

Exclusion Criteria:

* AVF after neoplasty.
* Arteriovenous grafts.
* Anticipated live time less than one year.
* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Primary outcomes:
measure: Prevalence of AVF aneurysm and stenosis.
timeFrame: 12 months
Secondary outcomes:
measure: Proportions of AVF dysfunction in different groups.
timeFrame: 12 months
measure: The size of venous aneurysm.
timeFrame: 12 months
measure: Diameter of venous stenosis.
timeFrame: 12 months
measure: Percentages of unsuccessful cannulations.
timeFrame: 12 months
measure: Events of AVF obstruction.
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friedship Hospital
state: Beijing
Study officials:
affiliation: Kidney Disease Faculty of Capital Medical University
name: Dongliang Zhang, Doctor
role: STUDY_CHAIR
affiliation: Nephrology Department of Beijing Friendship Hospital
name: Wenying Cui, Bachelor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01388959: A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma
Official title: Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-75 years of age
* Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
* Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)

Exclusion Criteria:

* Active viral hepatitis
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients not willing to sign informed consent form

Primary outcomes:
measure: Treatment response rate according to World Health Organization criteria (Group A)
timeFrame: Day 50
measure: Normalization of B-cell lymphoma 2 levels
timeFrame: Day 50
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Duration of treatment response
timeFrame: 3 years
Other outcomes:
Locations:
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01178359: Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
Official title: Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiac Arrest
Keywords: cardiac arrest
ventricular fibrillation
nitrite
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medic One Foundation
First posted: 2010-08-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than 20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac arrest and our group is eager to test this hypothesis in a clinical trial. Our overall hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will increase the proportion of patients who will survive cardiac arrest. In preparation for a clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary goal of this study.

Detailed description: Sixteen patients will be randomized to receive normal saline (n=5) or doses of IV nitrite (n=11). During the nitrite infusion and for 120 min after the infusion is completed, blood pressure and heart rate will be monitored.

The first 3 patients randomized to receive IV nitrite will receive the lowest dose (1 mg) of IV nitrite and compared to one placebo treated patient. If there is no significant decrease in blood pressure or elevation in heart rate, we will then dose escalate to the 6 mg dose in 4 patients and placebo in two patients. Dose escalation to the highest (14 mg) dose will again be contingent on the absence of significant hypotension or tachycardia in the drug treated patients compared to the pooled (n=3) placebo treated patients. The final block of patients will be randomized to the high nitrite dose (n=4) or placebo (n=2). Final comparisons of all groups will be made to the pooled (n=5) placebo group

Eligibility criteria: Inclusion Criteria:

* Successfully resuscitated from cardiac arrest by paramedics in the field Age 18 or older Comatose IV access

Exclusion Criteria:

* traumatic cause of cardiac arrest known DNAR Patient requiring vasopressors at time of randomization SBP \<105 PaO2 of less than 90% on FiO2 of 1.0

Primary outcomes:
measure: Blood pressure
timeFrame: 2 hour
measure: nitrite concentration levels in blood
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Francis Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547859: Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism
Official title: Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: microcirculation
cardiac surgery
metabolism
capnometry
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 30
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: post cardiac surgery patients in the first two hours of ICU treatment

Brief summary: The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.

Detailed description: Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.

Eligibility criteria: Inclusion Criteria:

* cardiac surgery
* informed consent
* age \> 18

Exclusion Criteria:

* pregnancy
* off pump procedure
* rectal fecal contamination

Primary outcomes:
measure: Relation between MFI (by SDF) and capno
timeFrame: 6 months
Secondary outcomes:
measure: Relevance of changes in flow and metabolism
timeFrame: 6 months
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Department of ICU
state: PO box 888
Study officials:
affiliation: Frisius Medisch Centrum
name: E.C. Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.
Clinical trial NCT02427659: VR High Tech Pain Control Burn Wound Care
Official title: High Technology Pain Control During Burn Wound Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burn
Keywords: VRD
Virtual Reality as Distraction during Procedure
Burn Wound Care
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2015-04-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.

Detailed description: This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.

Subjects in all three groups will receive the following questionnaires:

Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history

Primary outcomes:
measure: "Pain" as measured by McGill Short Form Pain Questionnaire
timeFrame: up to an hour
measure: "Pain" as measured by Nurse Graphic Rating Scale
timeFrame: up to 3 hours
measure: "Pain and anxiety" as measured by Graphic Rating Scale
timeFrame: up to an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University fo Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03506659: Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée
Official title: Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Difference, Individual
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group open label Monocentric
Primary purpose: DIAGNOSTIC

Brief summary: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Detailed description: Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Background:

Sudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.

Main objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.

Methodology :

Recruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire

Analysis of the results after the recruitment has been completed.

Eligibility criteria: Inclusion Criteria:

* Adult

Exclusion Criteria:

* Patients group : Not have a chronic neuropathy

Primary outcomes:
measure: Difference of timing for Electrochemical skin conductance
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: ERASME Hospital
Study officials:
affiliation: Erasme hospital
name: Turgay TUNA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595659: Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Official title: Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidents, Traffic
Keywords: Risk
Young drivers
Alcohol
Passengers
Gender
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Among the many risk factors that contribute to young drivers' crash involvement, two are critical: peer passenger presence, which is unique to young drivers, and the influence of alcohol, a universal risk for drivers but one against which young drivers are most susceptible. Clarification of how passenger presence interacts with alcohol consumption to increase risk is needed. The impact of experimentally manipulated passenger characteristics and alcohol quantity on risky driving is observed using driving simulation and a random assignment experimental design with a sample of 18-21 year old male and female drivers.


Eligibility criteria: Inclusion Criteria:

* being 18 to 21 years of age (18 years old is the legal age for alcohol consumption in the province of Quebec)
* past experirence with drinking at least 2 alcoholic beverages in one episode
* having a provisional driving license
* driving in the past 3 months

Exclusion Criteria:

* health problem that contraindicates participation
* pregnant or breastfeeding
* signs of problem drinking
* positive BAC or recent drug use measured at arrival

Primary outcomes:
measure: Risky driving in a simulator
timeFrame: within 1 hr after alcohol dose
Secondary outcomes:
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Marie Claude Ouimet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914559: Glucose Response in Persons with Type 2 Diabetes
Official title: Plasma Glucose and Insulin Response in Adults with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized crossover design with oral nutrition supplement interventions.

Detailed description: This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Eligibility criteria: Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg/dl
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Patients with anemia
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Patients with anemia
* Currently participating in another clinical trial

Primary outcomes:
measure: Area under the blood glucose curve
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curve
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Nestle Health Science
name: Krysmaru Araujo Torres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00281359: A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Official title: A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
dynamic splinting
contractures
heat therapy
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Action Medical Research
First posted: 2006-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.

Detailed description: When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?

Eligibility criteria: Inclusion Criteria:

children with cerebral palsy -

Exclusion Criteria:

absent thermal sensation -

Primary outcomes:
measure: Range of motion
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
state: Shropshire
Study officials:
affiliation: Robert Jones and Agnes Hunt Orthopaedic Hospital
name: John Patrick
role: PRINCIPAL_INVESTIGATOR
References: