louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04827563: Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib
Official title: Risk Factors for Dyspnea and Cardiotoxicity in Patients With Multiple Myeloma Who Receive Carfilzomib: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Shortness of Breath
Dyspnea
Cardiotoxicity
Keywords: multiple myeloma
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with multiple myeloma who are being treated with carfilzomib.

Brief summary: This study will explore why some multiple myeloma patients who receive carfilzomib (an anti-cancer medication) experience shortness of breath while others do not. The purpose of this research is to gather information on the effectiveness of the EndoPAT device, which is FDA-approved to assess the health of a patient's blood vessels. These assessments will help doctors leading the study determine the reasons why patients may develop shortness of breath (dyspnea) when being treated with carfilzomib and ways to better prevent this shortness of breath.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Confirmed diagnosis of multiple myeloma
* Newly-diagnosed multiple myeloma, or relapsed/refractory multiple myeloma with receipt of 1-3 previous lines of therapy and with a 2-week washout from prior therapy
* Receiving carfilzomib as either standard-of-care therapy or as part of a clinical trial

Exclusion Criteria:

* Previous receipt of anthracycline chemotherapy
* Previous receipt of carfilzomib
* Four or more previous lines of therapy
* Active pregnancy at the time of enrollment

Primary outcomes:
measure: Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients
timeFrame: 2 months
Secondary outcomes:
measure: Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function
timeFrame: 2 months
measure: The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea
timeFrame: 2 months
measure: Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function
timeFrame: 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago - Comprehensive Cancer Center
name: Jeanne DeCara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043663: Effects of Virtual Reality on Perioperative Pediatric Anxiety
Official title: Effects of Virtual Reality on Perioperative Pediatric Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoperative Anxiety
Maladaptive Postoperative Behavior
Emergence Delirium
Keywords: virtual reality
pediatric surgery
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.

Detailed description: It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.

Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.

Eligibility criteria: Inclusion Criteria:

* Child between 4 and 12 years old
* Elective ambulatory surgery
* Parents posses a smart phone
* Child and parents understand Spanish or Catalan
* Patient information has been explained
* Informed Consent is signed
* Surgery scheduled in the morning

Exclusion Criteria:

* Child has hearing impairment
* Child has visual impairment
* Child has previous experience of anesthesia
* American Society os Anesthesiologists (ASA) score of III or greater
* Children with history of seizures
* Children under psychiatric treatment

Primary outcomes:
measure: Perioperative Anxiety level
timeFrame: baseline to 1 day
Secondary outcomes:
measure: Salivary Cortisol level
timeFrame: baseline to 1 day
Other outcomes:
measure: Anxiety levels
timeFrame: baseline to 1 day
Locations:
city: Badalona
country: Spain
facility: Teresa Franco
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Teresa Franco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03396263: Online vs. Face-to-face Nutritional Advice in Kuwait (EatWellQ8)
Official title: Randomized Control Trial to Evaluate the Effectiveness of Online Versus Face-to-face Nutrition Advice in Kuwait (The EatWellQ8 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Dietary Habits
Keywords: Personalised nutrition
Mobile web application
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The EatWellQ8 study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, compared with face-to-face nutritional advice, in increasing diet quality.

Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).


Eligibility criteria: Inclusion Criteria:

* aged \> 21 years

Exclusion Criteria:

* aged \< 21 years old
* not living in the UK
* pregnant/lactating
* no or limited access to internet
* following a prescribed diet for any reason
* intolerance or food allergy
* subject with diabetes, or any other metabolic disorder or illness that alters nutritional requirements

Primary outcomes:
measure: Dietary change
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: baseline, 6 weeks, 12 weeks
measure: Physical activity
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
Clinical trial NCT04584463: Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.
Official title: Factors Associated With Neurological Prognosis 30 Days After an ICU Admission for a Myocardial Infarction Complicated by an Out-of-Hospital Cardiac Arrest : an Observationnal Multicentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-Of-Hospital Cardiac Arrest
Myocardial Infarction
Coma
Outcome, Fatal
Neurologic Dysfunction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient older than 18 years old admitted in an ICU following resurected out-of-hospital cardiac arrest due to a type 1 myocardial infarction

Brief summary: This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.

Detailed description: Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome.

This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest.

This is designed to be a observationnal, prospective, multicentric national french study

Eligibility criteria: Inclusion Criteria:

* aged of 18 years old or more
* non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation
* patient admitted in ICU
* the reason for admission is a resurected out-of-hospital cardiac arrest
* the cause of the cardiac arrest is a type 1 myocardial infarction

Exclusion Criteria:

* refractory cardiac arrest (no flow \> 30 minutes in normothermia)
* in-hospital cardiac arrest
* pregnancy
* patient under juridic protection
* opposition of the patient, or of his family is he is unable to consent.

Primary outcomes:
measure: Neurologic outcome (CPC)
timeFrame: 30 day from in-ICU admission
Secondary outcomes:
measure: Neurologic outcome (Rankin)
timeFrame: 30 day from in-ICU admission
measure: death
timeFrame: 30 day form in-ICU admission
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01538186: Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients
Official title: Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Bifurcation Lesions
Keywords: Coronary intervention
PCI of the side branch
Lead sponsor: Krankenhaus Hetzelstift
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective observational study included patients (pts) with PCI of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. We included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Brief summary: This retrospective observational study included patients (pts) with percutaneous coronary intervention (PCI) of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. The investigators included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Two different methods were compared: group A represents patients with a simple strategy without any treatment of the side branch (SB). Group B consisted of patients where the SB was treated (PCI and/or stenting).

For the treatment of bifurcation lesions we used the concept of "provisional stenting", indications for the treatment of the SB were residual stenosis \> 50 %, TIMI flow reduction \< 2. Final-kissing PCI was intended in all patients of group B.

MACE during follow-up was evaluated in all patients.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients with a bifurcation lesion, where the side branch was covered with a stent placed inside the main branch.

Exclusion Criteria:

* Patients with an in-stent-restenosis, patients with a therapy using a drug coated balloon during the procedure (inside the main branch and/or the side branch) and patients where the side branch was not covered by the stent inside the main branch.

Primary outcomes:
measure: Major adverse cardiac outcome
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Neustadt/Weinstrasse
country: Germany
facility: Hetzelstift
state: Rheinland-Pfalz
Study officials:
References:
citation: von Korn H, Stefan V, van Ewijk R, Chakraborty K, Sanwald B, Andel R, Hemker J, Hink U, Ohlow M, Lauer B, Muenzel T. Treatment of coronary bifurcation lesions: stent-covering of the side branch with and without PCI of the side branch: a retrospective analysis of all consecutive patients. BMC Cardiovasc Disord. 2013 Apr 4;13:27. doi: 10.1186/1471-2261-13-27.
Clinical trial NCT01343186: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects
Official title: A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Peginterferon
Healthy subject
Pharmacokinetics
Pharmacodynamics
Safety
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Age between 18 and 45, inclusive
* Body mass index(BMI)between 19 and 26, inclusive
* Sign informed consent

Exclusion Criteria:

* Women of pregnant or lactation
* Known hypersensitivity to interferon or any other components of the study drug
* History of mental disease or genetic disease
* History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
* Significant disease in heart, liver, kidney, lung or any other major organs
* Alcoholic, smokers or drug abusers
* Blood donation, or massive blood loss due to injury or surgery within 3 months
* Other conditions which in the opinion of the investigator preclude enrollment into the study

Primary outcomes:
measure: Measuring interferon levels in blood samples
timeFrame: from 0 to 408 hours following injection
measure: Different blood interferon biomarkers (such as 2,5-OAS, neopterin)
timeFrame: from 0 to 408 hours following injection
Secondary outcomes:
measure: Adverse events
timeFrame: up to 3 weeks following injection
measure: Anti-interferon antibody
timeFrame: baseline and week 2 after injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital of China
Study officials:
affiliation: Beijing 302 Hospital
name: Wei Zhenman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979286: The Effect of Kinesiotaping on Sprint and Dynamic Balance in Children
Official title: The Immediate Effect of Gastrocnemius Kinesiotaping on Sprint and Dynamic Balance in Physically Active Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Performance in Children
Keywords: soccer
child
sprint
dynamic balance
kinesiotaping
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 44
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the acute effects of kinesio taping applied to the gastrocnemius muscles of children enrolled in soccer school on sprint and dynamic balance.Children who meet the required criteria will be randomly placed in the kinesio taping and placebo groups by drawing lots. Dynamic balance and sprint abilities of the participants were evaluated before and immediately after taping. Y Balance Test will be used to evaluate dynamic balance. Measurements were taken in the anterior, posteromedial and posterolateral directions of the right and left sides.10 m and 20 m sprint tests will be used to assess speed ability. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 8-12
* To be actively participating in football training.

Exclusion Criteria:

* Those with orthopedic, neurological and congenital problems.
* Those with any systematic disease.
* Those who have experience taping before.
* Those who have undergone any surgery within the last 1 year.
* Those who have been absent from training for more than 2 weeks in the last three months.

Primary outcomes:
measure: 10m Sprint Test
timeFrame: 1 hour
measure: 20m Sprint Test
timeFrame: 1 hour
measure: Y-Balance Test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT05517486: Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
Official title: Parallel Study to Evaluate the Pharmacokinetics, Dose Proportionality, Safety and Tolerability of GTX-101 (Bupivacaine Hydrochloride Metered Dose Spray) and Subcutaneous Injectable Bupivacaine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Postherpetic Neuralgia
Lead sponsor: Grace Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects.

The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.

Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
* Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator

Exclusion Criteria:

* History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
* History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability

Primary outcomes:
measure: Cmax between 0 hour to 240 hour after study drug administration
timeFrame: From 0 hour to 240 hour after study drug administration
measure: Tmax between 0 hour to 240 hour after study drug administration
timeFrame: From 0 hour to 240 hour after study drug administration
measure: AUC last
timeFrame: From 0 hour to 240 hour after study drug administration
measure: AUC inf
timeFrame: From 0 hour to 240 hour after study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinical Research Unit
Study officials:
affiliation: Clinical Research Unit
name: Eric Sicard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06752486: Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study
Official title: Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain After Photorefractive Keratectomy
VAS Will be Used to Assess Pain Postoperative
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 64
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: The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.

Detailed description: To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* preoperative stable refraction for at least one-year,
* normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.

Exclusion Criteria:

* Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
* amblyopic patients,
* patients with a history of previous ocular surgeries,
* herpetic eye infection, or corneal dystrophies.
* Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
* Diabetics,
* Hypertensives,
* Kidney problems,
* breathing problems
* Adults older than 65 years.
* Previous allergy or adverse reaction to the used drugs.
* History of drug abuse or alcohol abuse problems
* History of mood problems, depression suicidal thoughts or behavior

Primary outcomes:
measure: Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.
timeFrame: 72 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmolgy
Study officials:
References: