louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01093547: Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
Official title: Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: End Stage Renal Disease
Continuous Ambulatory Peritoneal Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.


Eligibility criteria: Inclusion Criteria:

* must be over 18-years old and under 75-years old
* Peritoneal Equilibration Test (PET) result of high, high average or low average transport
* non-diabetic patient
* be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
* prevalent patients that have been in peritoneal dialysis at least 30 days
* wish to participate

Exclusion Criteria:

* Have a Charlson score of \>7 and have a life expectancy of less than 12 months
* HIV positive
* present with peritonitis in the month prior to randomisation
* present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
* have active cancer
* pregnant women
* patients with known allergy to starch-based polymer
* patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures
* women incapable of maintaining an effective and accepted contraception method

Primary outcomes:
measure: HOMA index
timeFrame: 4 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Ultrafiltration of long-dwell exchange
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Hospitalization rate
timeFrame: 12 months
measure: Time during hospitalization
timeFrame: 12 months
measure: Incidence of Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Bogota
country: Colombia
Study officials:
affiliation: Baxter, RTS Colombia
name: Mauricio R Sanabria, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141447: Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
Official title: Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hemorrhage
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.


Eligibility criteria: Inclusion Criteria:

* clinic-based D\&E at 18 weeks gestational age and above
* speaks English or Spanish

Exclusion Criteria:

* refuses IV
* history of coagulopathy
* anticoagulant use in the preceding five days
* chorioamnionitis or sepsis
* suspected placenta accreta spectrum
* intrauterine fetal demise
* multiple gestation
* use of misoprostol for cervical preparation

Primary outcomes:
measure: Hemorrhage
timeFrame: day of procedure
measure: Quantitative blood loss
timeFrame: day of procedure
Secondary outcomes:
measure: Procedure time
timeFrame: day of procedure
Other outcomes:
measure: Patient satisfaction and pain scores
timeFrame: day of procedure
measure: Ease of procedure
timeFrame: day of procedure
measure: Rate of additional uterotonics
timeFrame: day of procedure
measure: Cost of additional uterotonics
timeFrame: day of procedure
Locations:
city: Denver
country: United States
facility: Comprehensive Women's Health Center
state: Colorado
Study officials:
References:
Clinical trial NCT00560547: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Official title: An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 0
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 long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* regular long-term hemodialysis therapy with the same mode of dialysis for \>=3 months;
* continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* active malignant disease (except non-melanoma skin cancer).

Primary outcomes:
measure: Percentage of patients maintaining average Hb concentration within target range during evaluation period
timeFrame: Weeks 17-24
Secondary outcomes:
measure: Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range
timeFrame: Weeks 17-24
measure: Dose adjustments; RBC transfusions
timeFrame: Throughout study
measure: AEs, laboratory parameters, vital signs
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aalborg
country: Denmark
city: Fredericia
country: Denmark
city: Roskilde
country: Denmark
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751047: Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children
Official title: Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 154
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.


Eligibility criteria: Inclusion Criteria:

* Children with American Society of Anesthesiologist (ASA) physical status 1, 2
* Children with normal body mass index

Exclusion Criteria:

* Difficult airway management
* pulmonary disease
* upper respiratory infection
* risk of pulmonary aspiration
* intestinal obstruction or abdominal distension
* stroke history or moyamoya disease

Primary outcomes:
measure: Incidence of gastric insufflation
timeFrame: During facemask ventilation (90 seconds)
Secondary outcomes:
measure: The number of patients with adequate tidal volume
timeFrame: During facemask ventilation (90 seconds)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615147: Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
Official title: Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Pulmonary Embolism
Keywords: Any cancer
suspected pulmonary embolism
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 213
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to MSKCC Urgent care unit

Brief summary: The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots.

A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).


Eligibility criteria: Inclusion Criteria:

* All patients evaluated in the urgent care center and determined to need with CT pulmonary angiogram to rule out pulmonary embolism based on signs and symptoms such as dyspnea, pleuritic chest pain, tachycardia, and/or pulse oxygen desaturation will be included.

Exclusion Criteria:

* Inability to obtain CT pulmonary angiogram secondary to lack of IV access, contrast allergy or lack of consent.
* CT pulmonary angiogram not done with routine protocol for rule out pulmonary embolism.
* Less than 21 years of age

Primary outcomes:
measure: The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose.
timeFrame: conclusion of study
Secondary outcomes:
measure: To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.
timeFrame: conclusion of study
measure: To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT01003847: Differential Metabolic Effects of Fenofibrate and Fatty Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
Keywords: Insulin resistance
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients


Eligibility criteria: Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Primary outcomes:
measure: flow-mediated dilation
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: insulin resistance
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT00001147: Blood Sampling for Neurochemical and Genetic Testing
Official title: Blood Sampling for Neurochemical and Genetic Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Nervous System Disease
Healthy
Hypertension
Pheochromocytoma
Keywords: Dopamine
Metanephrine
Norepinephrine
Epinephrine
Catecholamines
Tyrosine Hydroxylase
Monoamine Oxidase
Phenosulfotransferase
Sympathetic Nervous System
Normetanephrine
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study involves sampling blood from both normal volunteers and patients with diseases known or suspected to involve body chemicals called catecholamines. The blood will be used to establish normal values for plasma levels of catecholamines and related neurochemicals; to test for abnormal neurochemical patterns in patients; and to establish a "bank" of DNA from normal volunteers and from patients to be used in future studies about possible alterations of catecholamine-related genes.

Study participants will report to NIH after fasting overnight except for water or noncaloric, noncaffeinated beverages. They must not have taken Tylenol for at least 5 days. Blood will then be drawn. DNA will be extracted and stored in the freezer for future studies.

Detailed description: This project is to allow blood sampling from normal volunteers and patients with dysautonomia, pheochromocytoma, hypertension, or neurogenetic diseases involving catecholaminergic systems. The blood is used to establish normal values for plasma levels of catechols and related neurochemicals; test for abnormal neurochemical patterns in patients; and establish a "bank" of DNA samples from normal volunteers and from patients, to be used in future studies about mutations or polymorphisms of catecholamine-related genes.

Eligibility criteria: INCLUSION CRITERIA:

The subjects are healthy normal volunteers or patients with dysautonomia, pheochromocytoma, hypertension, or neurogenetic diseases involving catecholaminergic systems. Children of any age above 4 years may participate. In the case of minors, consent is obtained from an adult who is legally responsible for the subject.

EXCLUSION CRITERIA:

Subjects in whom anatomic or technical factors preclude insertion of an arm intravenous (i.v.) catheter are excluded. Normal volunteers taking any prescribed medication are excluded. Normal volunteers who smoke cigarettes or consume alcohol daily are excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Goldstein DS, Lenders JW, Kaler SG, Eisenhofer G. Catecholamine phenotyping: clues to the diagnosis, treatment, and pathophysiology of neurogenetic disorders. J Neurochem. 1996 Nov;67(5):1781-90. doi: 10.1046/j.1471-4159.1996.67051781.x.
Clinical trial NCT05214547: Effectiveness of Focal Vibration in Shoulder Pathology
Official title: Focal Vibration Therapy Effectiveness in the Treatment of Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Shoulder
Keywords: Pain, Shoulder
Vibration
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 20
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: We hypothesize that focal vibration therapy will reduce pain, increase the mobilization of the glenohumeral joint, and will improve functionality in patients with adhesive capsulitis.

Detailed description: The underlying mechanism of focal vibration therapy in individuals with adhesive capsulitis still remains unclear. Considering the physiological mechanism of focal vibration therapy, the effect of focal vibration therapy on pain, function, and resting muscle tone in patients with adhesive capsulitis will be evaluated. There are no studies examining the effect of focal vibration therapy on shoulder muscle tone in individuals with adhesive capsulitis.

Eligibility criteria: Inclusion Criteria:

* Patients aged \> 18 years
* Unilateral adhesive capsulitis of the shoulder
* The symptom duration \> 3 months
* Shoulder pain
* The limited glenohumeral joint active range of motion of greater than 50% in at least three specific movements among abduction, flexion, internal rotation, and external rotation

Exclusion Criteria:

* Previous shoulder surgeries
* Massive, minor, and major rotator cuff tears
* Pain and muscle strength loss due to neurological causes
* History or presence of malignancy
* Osteoporosis
* Diabetes

Primary outcomes:
measure: Change from Baseline Shoulder Pain at 4 weeks
timeFrame: At 4 week
measure: Change from 4 weeks Shoulder Pain at 6 weeks
timeFrame: At 6 week
Secondary outcomes:
measure: Change from Baseline Range of Motion of Shoulder Joint at 4 weeks
timeFrame: At 4 weeks
measure: Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks
timeFrame: At 6 weeks
measure: Change from Baseline Shoulder Function at 4 weeks
timeFrame: At 4 weeks
measure: Change from 4 weeks Shoulder Function at 6 weeks
timeFrame: At 6 weeks
Other outcomes:
measure: Change from baseline Shoulder Muscle Tone at 6 weeks
timeFrame: At 6 weeks
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Tülay Çevik Saldıran, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05695547: VR Education in Patients Undergoing Coronary Angiography
Official title: Non-inferiority of Virtual Reality Augmented Education in Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Arteriosclerosis
Keywords: Virtual Reality
Education
Lead sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare standard education with VR augmented education in patients undergoing selective coronary angiography.

Detailed description: The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior toa selective coronary angiography. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help them to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures the patient need to take after the procedure.

Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.

Eligibility criteria: Inclusion Criteria:

* Patients with indication for undergoing coronary angiography

Exclusion Criteria:

* Visual impairment

Primary outcomes:
measure: Quality of VR augmented eduacation assessed by a questionaire
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: