louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03202524: Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
Official title: Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Ascites Hepatic
Keywords: Paracentesis
Albumin
Plasma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: Large volume paracentesis with albumin administration is the standard of care for patients with refractory ascites complicating end-stage liver disease. However, the use of albumin is frequently limited due to expense and occasional short supply. The goal of this study is to demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for volume expansion at the time of a large volume paracentesis.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria
3. Ability to provide informed consent (Grade 0 to 1 HE)
4. Grade 3 ascites or refractory ascites
5. Ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month
6. No diuretic use

Exclusion Criteria:

1. Inability to obtain informed consent
2. Age less than 18
3. Hepatic Encephalopathy Grade \> 1
4. Septic shock
5. Active infection
6. Respiratory failure
7. Heart failure with reduced ejection fraction of ≤ 50%
8. Moderate or severe pulmonary hypertension
9. History of stroke
10. Unstable coronary artery disease
11. Chronic kidney disease (GFR \<60)
12. GI bleed within 2 weeks
13. Any licorice within 2 weeks of starting the study
14. Any Beta Blocker use within the last 2 weeks
15. Any diuretic use within 2 weeks
16. Absence of paracentesis within 2 weeks
17. Absence of volume expanders within 2 weeks
18. INR \> 1.7

Primary outcomes:
measure: Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
timeFrame: 6 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Samuel Sigal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526224: Teriflunomide Tecfidera LMCE
Official title: Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tecfidera
Teriflunomide
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with MS who have used dimethyl fumarate or teriflunomide and had magnetic resonance imaging at baseline (before starting disease modifying therapy (DMT) in question), 12 months after starting DMT, and 24 months after starting DMT.

Brief summary: This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)


Eligibility criteria: Inclusion Criteria:

* Diagnosed with MS according to McDonald criteria
* Age 18-65 years
* Relapsing disease course
* Expanded Disability Status Scale (EDSS) score of ≤ 5.5
* MRI obtained at baseline (medication start date), 12 months, and 24 months
* Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label
* Clinical information available over the 24 month follow-up
* None of the exclusion criteria

Exclusion Criteria:

* Diagnosis of non-relapsing MS
* Use of experimental drug or investigational procedure during the study period
* Pregnancy during study period
* Severe hepatic impairment
* Relapse within 30 days prior to any of the 3 MRIs
* Corticosteroid use within 30 days prior to the MRIs
* Teriflunomide patients who have used leflunomide
* Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone
* Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation

Primary outcomes:
measure: Percent change in CGM between teriflunomide and dimethyl fumarate
timeFrame: 24 months
measure: LM CE lesions at 24 months
timeFrame: 24 months
measure: CGM atrophy and LM inflammation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
References:
citation: Zivadinov R, Bergsland N, Carl E, Ramasamy DP, Hagemeier J, Dwyer MG, Lizarraga AA, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of Teriflunomide and Dimethyl Fumarate on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective, Observational, Case-Control Pilot Study. J Clin Med. 2019 Mar 12;8(3):344. doi: 10.3390/jcm8030344.
Clinical trial NCT00961324: A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
Official title: A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 54
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: This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-65 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve during one dosing interval at steady state
timeFrame: 0-24 hours (derived on treatment days 6, 9 and 12)
Secondary outcomes:
measure: Area under the NN1250 concentration-time curve during one dosing interval at steady state
timeFrame: 0-24 hours (derived on treatment days 6, 9 and 12)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012 Sep;14(9):859-64. doi: 10.1111/j.1463-1326.2012.01627.x. Epub 2012 Jun 7.
citation: Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.
citation: Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.
Clinical trial NCT01184924: Evaluation of the Arthritis Foundation Tai Chi Program
Official title: Evaluation of the Arthritis Foundation Tai Chi Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: Arthritis
Tai Chi
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2010-08-19
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to assess the effectiveness and feasibility of the arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most prevalent chronic condition in the US and a leading cause of disability, is characterized by chronic pain and progressive impairment of joints and soft tissues. Promoting physical activity is a key public health strategy to addressing arthritis management, but more scientific data regarding effectiveness and feasibility are need to support the promotion of the AF Tai Chi Program as an exercise intervention for people with arthritis.


Eligibility criteria: Inclusion Criteria:

* Self-Reported doctor diagnosed arthritis
* Age 18 years or older
* Able to move independently without assistance

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Cognitive impairment
* Serious medical conditions: History of MI, stroke, prescribed beta-blockers, surgery in past 6 months, uncontrolled hypertension, chest pain, diabetes mellitus
* Severe impairment of physical functioning
* Participation in Tai Chi exercise in last 3 months

Primary outcomes:
measure: Arthritis symptoms.
timeFrame: Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
measure: Arthritis Self Efficacy (ASE)
timeFrame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
measure: Falls Surveillance
timeFrame: Baseline, 8 weeks from baseline assessment, 16 weeks from baseline assessment.
measure: 50 Foot Walk Test
timeFrame: Baseline, 8 weeks from baseline assessment
measure: Multidirectional Reach Test
timeFrame: Baseline, 8 weeks from baseline assessment
measure: Timed Chair Stands Test
timeFrame: Baseline, 8 weeks from baseline assessment
measure: Single Leg Stance (SLS)
timeFrame: Baseline, 8 weeks from baseline assessment
Secondary outcomes:
measure: Secondary outcomes are psychosocial measures.
timeFrame: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina at Chapel Hill, Thurston Arthritis Research Center
name: Leigh F Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929524: Intranasal Ketamine as a Sedative for Venipuncture
Official title: Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Respiratory Tract Disease
Acute Pain
Diseases of the Digestive System
Keywords: Ketamine
Intranasal administration
Pediatric nursing
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 39
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial, controlled, double-blind, parallel two-arm.

Detailed description: Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.

Eligibility criteria: Inclusion Criteria:

* Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
* Aged 3 months to 12 years;
* Requiring venipuncture independent research.

Exclusion Criteria:

* Severe neurological sequelae;
* Patients who need immediate venipuncture at risk;
* Presence of active nosebleeds;
* Patients using drugs sedative and analgesic continuos;
* Children who have experienced clinical change with ketamine.

Primary outcomes:
measure: Decreased venipuncture Time
timeFrame: Expected 3 minutes difference between the 2 groups
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Jefferson Piva
role: STUDY_DIRECTOR
References:
Clinical trial NCT02135224: the Effects of Epidural Fentanyl on Vaginal Delivery
Official title: The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Dilatation
Bishop Score
Duration of Delivery
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists physical status I or II
* nulliparous
* normal singleton uncomplicated pregnancies of more than 38 weeks
* cephalic presentation of the fetus
* anticipated vaginal delivery
* active stage of labour
* cervical dilatation between 3-5 cm
* regular uterine contractions
* normal cardiotocographic recordings.

Exclusion Criteria:

* medical problems during pregnancy
* BMI≥40 kg m-2
* opioid allergy
* prior administration of opioids or other analgesics

Primary outcomes:
measure: cervical dilatation
timeFrame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
Secondary outcomes:
measure: Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
timeFrame: every 60 min from the time the first epidural dose is administered up to delivery
Other outcomes:
measure: duration of delivery
timeFrame: min between first epidural dose and delivery of the baby
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
Study officials:
affiliation: University of Athens
name: Chryssoula Staikou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02561624: Hati Salama (Secure Voucher)
Official title: Expanding the Successful E-voucher System to Improve Malaria Prevention and Fight New Global Health Threats Through Innovative Health Partnerships and Mobile Phone Technology in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: mHealth
Text message
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Mennonite Economic Development Associates
First posted: 2015-09-28
Enrollment: 5219
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.


Eligibility criteria: Inclusion Criteria:

* Pregnant women capable of providing informed consent

Primary outcomes:
measure: Increased uptake of long-lasting insecticide treated nets from retailers using an electronic voucher through text messaging.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Pamoja Tunawez
Study officials:
affiliation: Queen's University
name: Karen Yeates, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04185324: Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study
Official title: Effectiveness of Visual Cues and Verbal Storytelling in Teaching Preschool Children Zippering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Typical Preschoolers Who Can Not Zipper
Lead sponsor: Salus University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 28
Sex: ALL
Minimum age (years): 42
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two cohort
Primary purpose: TREATMENT

Brief summary: Preschoolers are assigned to a control group or a comparison group to examine the efficacy of a new intervention to teach the skill of engaging and pulling up a zipper.

Detailed description: Purpose: This pilot study compares the efficacy of a standard teaching zippering vest presented with general verbal prompts to a modified teaching zippering vest presented with a related story and vocabulary in the acquisition of zippering skills among typically developing preschoolers. Institutional Review Board approval and parent consent was obtained.

Design: An experimental two group pre-post test design was used. Setting: Research occurred in a local preschool. Participants: Participants were recruited from fifty 3.6-to 4.11-year-old preschoolers.

Intervention: Eligible children received 3 zippering practice sessions with either a standard zippering vest (control group) or a modified vest with added visual and language cues (comparison group).

The treatment protocol for both cohorts of participants was administered over a three-week time period to minimize the impact of normal development.

Eligibility criteria: Inclusion Criteria: Child must be typically developing as assessed by the Developmental Assessment of Young Children 2 (DAYC-2) developmental screening.

Child must be between 42 and 60 months of age. Child must be unable to zip by a) parent report and b) three observed attempts to zipper -

Exclusion Criteria:

Child must meet inclusion criteria and be present at school during three researcher visits to the preschool within three consecutive weeks.

-

Primary outcomes:
measure: Zippering steps completed
timeFrame: all data was collected within three weeks for each child to minimize the impact of typical development
Secondary outcomes:
Other outcomes:
Locations:
city: Jenkintown
country: United States
facility: Little Joes preschool
state: Pennsylvania
Study officials:
affiliation: Salus University
name: Fern Silverman, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05669924: Neural Correlates of Acute Pain Dynamics
Official title: The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Mesolimbic system
Dopamine circuits
Psychophysics
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Pregnant
* History of chronic pain
* History of neurological diagnosis
* History of psychiatric diagnosis

Primary outcomes:
measure: Effect of methylphenidate on acute pain dynamics
timeFrame: 6 months
measure: Nucleus accumbens activation with acute pain dynamics
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Andrew D Vigotsky, MS
role: PRINCIPAL_INVESTIGATOR
References: