louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097655: Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
Official title: Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Tablets
Infection
Non Nucleoside Reverse Transcriptase Inhibitor
Tolerability
Viral load
Human immunodeficiency Virus
Effectiveness
Treatment-naïve
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Veeda Clinical Research
First posted: 2010-04-02
Enrollment: 3049
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Community sample; HIV-infected patients
* For Belgium: AIDS references centers (probability sample)

Brief summary: The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.

Detailed description: This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility criteria: Inclusion Criteria:

* Patients with HIV infection
* Patients that will be treated with Kaletra tablets independent from their participation in this study

Exclusion Criteria:

* Hypersensitivity against Kaletra or other ingredients
* Severe liver insufficiency
* No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
* Patients who received more than 1 protease inhibitor during their therapy history

Primary outcomes:
measure: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
timeFrame: Baseline (Week 0) to Week 144
measure: Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
timeFrame: Baseline (Week 0) to Week 144
Secondary outcomes:
Other outcomes:
measure: Prevalence of Adverse Events (Weeks 0-144), Per Event
timeFrame: Weeks 0 to 144
measure: Prevalence of Adverse Events (Weeks 0-144), Per Participant
timeFrame: Weeks 0 to 144
Locations:
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Sandra Bloch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06324955: Language During Inhalational Induction
Official title: A Prospective Randomized Study Comparing Positive Language vs Common Language During Inhalational Induction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergence Delirium
Anesthesia; Adverse Effect
Keywords: Anesthesia induction
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.


Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2 (Healthy Patients)
* Non-emergent cases
* 5-10 year olds
* Patients receiving inhalational induction

Exclusion Criteria:

* Non-English speaking
* History of prior inhalational inductions
* Hearing difficulty
* Behavioral difficulty (Autism, Oppositional Defiant Disorder)
* Patients receiving premedication other than midazolam

Primary outcomes:
measure: Induction compliance
timeFrame: Through Study Completion about 1 day
Secondary outcomes:
measure: Length of induction
timeFrame: Through Study Completion about 1 day
measure: Verbal refusal of mask
timeFrame: Through Study Completion about 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John Fiadjoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936555: The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Official title: The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Self-Acupressure
Functional composite
Quality of life
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems.

Detailed description: The application of Self-Acupressure helps in improving the functional composite and quality of life in Multiple Sclerosis patients.

Eligibility criteria: Inclusion Criteria:

* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research

Exclusion Criteria:

* None

Primary outcomes:
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 1. week
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 4. week
measure: Multiple Sclerosis Quality of Life Scale-54
timeFrame: 1.week
measure: Multiple Sclerosis Quality of Life Scale-54
timeFrame: 4.week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zain Universitiy
state: State
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz ÖZER, PhD
role: STUDY_CHAIR
References:
citation: Bastani F, Sobhani M, Emamzadeh Ghasemi HS. Effect of acupressure on fatigue in women with multiple sclerosis. Glob J Health Sci. 2015 Jan 26;7(4):375-81. doi: 10.5539/gjhs.v7n4p375.
Clinical trial NCT02434055: Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS
Official title: Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Extravasation of Contrast Media
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Osprey Medical, Inc
First posted: 2015-05-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with cardiovascular disease undergoing clinically indicated coronary or peripheral angiography

Brief summary: Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.

Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Detailed description: Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.

Eligibility criteria: Inclusion Criteria:

* subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.

Exclusion Criteria:

* None

Primary outcomes:
measure: Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Osprey Medical, Inc
name: Michele Shepard
role: STUDY_DIRECTOR
References:
Clinical trial NCT01430455: Tranylcypromine Treatment of Bipolar Depression
Official title: Tranylcypromine Treatment of Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder I or II
Keywords: Major Depressive Episode
Depression NOS
Bipolar Disorder
Bipolar Disorder I
Bipolar Disorder II
Bipolar Depression
Major Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.


Eligibility criteria: Inclusion Criteria:

1. History of Bipolar I, II
2. Currently depressed (major depressive episode or depression NOS)
3. Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
5. Prior adequate trial on at least one antidepressant.
6. Able to follow a tyramine-free diet
7. Must speak English

Exclusion Criteria:

1. Current psychosis
2. past psychosis not occurring during an episode of mania or depression
3. prior nonremission to tranylcypromine 60 mg/d (or greater)
4. currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
5. current (last six months) drug or alcohol abuse or dependence
6. significant suicide risk
7. significant cardiovascular risk

Primary outcomes:
measure: 29 Item Hamilton Rating Scale for Depression (HamD29)
timeFrame: Hamilton 29 score at baseline (start date of medication) and week 16
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT06352255: Pain and Anxiety During Local Block
Official title: Analysis of Pain and Anxiety With Carpule vs Syringe in Digital Anesthesia of the Hallux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Pain
Anxiety
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.

OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.

METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.

Result: after the completion of the study CONCLUSIONS: After the completion of the study


Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age
* Both sexes
* Participants must present nail pathology that requires surgical intervention.

Exclusion Criteria:

* Systemic degenerative
* Neuromuscular diseases
* Pregnant or likely to be pregnant

Primary outcomes:
measure: Grade of Pain postinyection
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Anxiety before the intervention
timeFrame: Immediately before the intervention, since it is a scale that scores from 1 to 3 the degree of anxiety of the patient prior to the surgical intervention.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Clinica Rayo
Study officials:
affiliation: University of Seville
name: ANA M RAYO PEREZ, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567355: Migraine Manager (R01)
Official title: Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Migraine
Migraine Disorders
Keywords: Migraine
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 160
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura
* Frequency of 8 or more headaches per month
* Access to the internet whether public (e.g., library) or private (e.g., home, personal)
* English fluency for patient and caregiver

Exclusion Criteria:

* Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review
* Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review

Primary outcomes:
measure: Headache frequency
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kevin Hommel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Scott Powers, PhD
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrew Hershey, MD, PhD
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Susan LeCates, MSN, FNP
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marielle Kabbouche-Samaha, MD
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: James Peugh, PhD
role: STUDY_CHAIR
affiliation: University of Virginia
name: Lee Ritterband, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05634655: Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary Tumors.
Official title: Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Tumors
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with PAs who underwent TSS at The Second Affiliated 62 Hospital Zhejiang University School of Medicine was retrospectively analyzed.

Brief summary: DNA methylation is one of the important ways of protein post-translational modification.Pituitary adenoma (PA) is a benign neuroendocrine tumor that originates from adenohypophysial 45 cells, and accounts for 10%-20% of all primary intracranial tumors. However some PAs can present with high invasiveness and irregular growth, which tend to compresses the optic chiasm and third ventricle, encase the internal carotid artery, and affect hormone secretion from the pituitary gland and hypothalamus. In this study we focus on the mechanism of DNA methylation on the invasiveness of pituitary tumors.


Eligibility criteria: Inclusion Criteria:

* 1) histologically confirmed PAs, 2) Non-function pituitary adenomas

Exclusion Criteria:

* 1) Associated with other tumors or serious underlying diseases, 2) the medical records were not complete, or the follow-up data were missing.

Primary outcomes:
measure: Residual tumor size
timeFrame: 1 week after surgery
measure: tumor recurrence
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT03969355: Mortality in Paediatric Intensive Care
Official title: Mortality in Tertiary Paediatric Critical Care Centre 2008-2012 Versus 2013-2017: Retrospective Cohort Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidity, Multiple
Keywords: Paediatric
Intensive care
Mortality
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017).

Brief summary: Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017

Detailed description: Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017. The patients records was retrospectively searched and the mortality was adjusted according to the primary admission diagnosis.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients admitted to intensive care in selected time period

Exclusion Criteria:

* Insufficient documentation

Primary outcomes:
measure: Paediatric intesive care unit mortality
timeFrame: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Secondary outcomes:
measure: Paediatric intesive care unit adjusted mortality
timeFrame: During Paediatric intesive care unit (PICU) stay Paediatric patients admitted to the intensive care in selected period (2008-2012. versus 2013-2017)
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno
name: Petr Štourač, assoc.Prof.MD.Ph.D
role: STUDY_CHAIR
References: