louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03968848: Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Official title: A Phase 1, Open-Label, Single-Dose Study to Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite (ACP-5862)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Hepatic Insufficiency
Healthy Subjects
Keywords: Hepatic
Acalabrutinib
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2019-05-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.


Eligibility criteria: Inclusion Criteria

* Women must be of non childbearing status
* Understands the study procedures in the ICF and be willing and able to comply with the protocol.
* Willingness and ability to swallow study drug capsule.
* Adult men or women, 18 to 75 years of age

Hepatic-Impaired Subjects Only:

* Subject has a diagnosis of chronic, stable HI.
* Subject's score on the Child-Pugh scale must range from 10 to 15 at screening.

Exclusion Criteria

* History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the PI.
* Dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study.
* History or presence of drug abuse within 2 years before screening.

Primary outcomes:
measure: Plasma Acalabrutinib PK Parameters
timeFrame: Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.
measure: Maximum Plasma Acalabrutinib Concentration
timeFrame: Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
Study officials:
References:
Clinical trial NCT05605548: Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: MitoQ
vascular function
cardiovascular health
exercise intolerance
Mitochondria
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-11-04
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.

Detailed description: In this study, a mitochondria-specific antioxidant will be compared to a placebo. Participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. A comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed of COPD
* Global Initiative for obstructive lung disease (GOLD) Stages II to IV

Exclusion Criteria:

* Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) \>0.7
* Heart Disease
* Diabetes
* Vasoactive medications
* Uncontrolled high blood pressure
* Fluid in lungs
* Sleep apnea
* Raynaud's Phenomenon
* Gangrene of the digits
* History of coagulation
* Pregnant women
* Children

Primary outcomes:
measure: Change in vascular function
timeFrame: Baseline and 6 weeks
measure: Change in Skeletal Muscle Oxygenation
timeFrame: Baseline and 6 weeks
measure: Change in oxidative stress
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in arterial stiffness
timeFrame: Baseline and 6 weeks
measure: Change in microvascular function
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez-Miguelez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03225248: Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia
Official title: Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 143
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Detailed description: Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Age \>19 years
2. Diagnosis of functional dyspepsia meeting Rome III criteria
3. At least three moderate or severe symptoms included in the Symptom Score
4. No structural lesions of upper gastrointestinal tract

Exclusion Criteria:

1. History of dyspepsia unrelated to functional dyspepsia or diseases
2. History of gastrointestinal surgery
3. History of malignancy in the previous 5 years
4. Psychiatric disorders including major depressive disorder and anxiety
5. Liver cirrhosis or abnormal liver laboratory findings
6. Advanced chronic kidney disease
7. Uncontrolled hypertension
8. Uncontrolled diabetes
9. Pregnancy and lactation
10. Recent history of taking medication affecting the gastrointestinal system

Primary outcomes:
measure: Change of symptom score of functional dyspepsia
timeFrame: 4weeks
Secondary outcomes:
measure: Change of symptom score of functional dyspepsia
timeFrame: 2weeks
measure: General symptom improvement
timeFrame: 2weeks, 4weeks
measure: NDI-K questionnaire
timeFrame: 4weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04626648: Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
Official title: Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized controlled cross-over trial was conducted in a simulator environment
Primary purpose: OTHER

Brief summary: Intraoperative stress among the surgical team can be a threat to patient safety and good teamwork. During surgery, surgeons often work under stressful conditions. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. Based on the hypothesis that an intraoperative pause including a sugar-containing drink would decrease surgeon's stress levels, the aim of this study is to compare stress levels, in relation to intraoperative stress and how this is affected by a pause including a sugar-containing drink in simulated operations.

Detailed description: A randomized controlled cross-over trial was conducted in a simulator environment. Primary endpoint was intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink. Secondary endpoints were change in heart rate, change in self-perceived stress measured by the State Trait Anxiety Inventory (STAI), and experience of the intraoperative pause.

Eligibility criteria: Inclusion Criteria:

* Surgeon within five years of specialization with basic laparoscopic skills, able to perform an appendectomy

Exclusion Criteria:

* diabetes
* Addison's disease
* medication with steroids or medication that affect heart rate (beta-blockers, calcium antagonists, antiarrhythmics, and digitalis) Smoking

Primary outcomes:
measure: Salivary cortisol
timeFrame: 10 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 3 hours
measure: self-perceived stress
timeFrame: 10 minutes
measure: Experience of the intraoperative pause.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
citation: Erestam S, Bock D, Andersson AE, Haglind E, Park J, Angenete E. The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers. Patient Saf Surg. 2021 May 29;15(1):23. doi: 10.1186/s13037-021-00294-6.
Clinical trial NCT01952548: Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and Tolerability
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will test single doses of the study drug in increasing amounts to see if it is safe.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion Criteria:

* Subject is a woman who is of childbearing potential or is breastfeeding.
* Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Primary outcomes:
measure: Adverse Events
timeFrame: 10 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT05757648: Buffered Local Anesthetic
Official title: Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Pain
Keywords: Dental surgery
Deep sedation
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.


Eligibility criteria: Inclusion Criteria:

* Healthy children or children with mild controlled systemic illness
* Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration

Exclusion Criteria:

* Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
* Antibiotic premedication requirement
* History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
* Has signs of dental pain, odontogenic abscess or facial cellulitis
* Allergy to local anesthetics or sulfites

Primary outcomes:
measure: Pain Score as Measured by the Behavior Pain Scale
timeFrame: Up to 10 minutes
measure: Change in Heart Rate as Measured by as Measured by Medical Record
timeFrame: Baseline, Up to 10 minutes
measure: Change in Diastolic Blood Pressure as Measured by Medical Record
timeFrame: Baseline, Up to 10 minutes
measure: Change in Systolic Blood Pressure as Measured by Medical Record
timeFrame: Baseline, Up to 10 minutes
measure: Change in CO2 Level as Measured by Medical Record
timeFrame: Baseline, Up to 10 minutes
measure: Change in Oxygen Saturation Level as Measured by Medical Record
timeFrame: Baseline, Up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Dental Clinic of Rainbow Center for Women and Children
state: Ohio
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Ying An, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373748: Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
Official title: A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Rehabilitation
Lead sponsor: BioGaming Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.


Eligibility criteria: Inclusion Criteria:

* The subject is willing to comply with protocol-specified evaluations
* Subject signed informed consent

Exclusion Criteria:

* Pregnant or nursing female subjects
* Surgical procedures or injuries to the extremities that could potentially affect physical functions
* Neurological and/or vestibular disease
* Cognitive impairment
* Subjects taking any prescribed drugs that could potentially affect physical function and balance

Primary outcomes:
measure: Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.
timeFrame: Baseline procedure
Secondary outcomes:
measure: Safety - Record of any adverse event
timeFrame: Baseline procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT00876148: Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting
Official title: Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B Virus
Allograft
Hematological Malignancies
Keywords: Incidence of hepatitis B after allografting
Risk of hepatitis B reactivation
Lamivudine prophylaxis
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2009-04-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of patients undergoing allografting for hematological malignancies

Brief summary: The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing an allograft for hematological malignancies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Azienda ospedaliera S Giovanni Battista
Study officials:
References:
citation: Giaccone L, Festuccia M, Marengo A, Resta I, Sorasio R, Pittaluga F, Fiore F, Boccadoro M, Rizzetto M, Bruno B, Marzano A. Hepatitis B virus reactivation and efficacy of prophylaxis with lamivudine in patients undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2010 Jun;16(6):809-17. doi: 10.1016/j.bbmt.2009.12.533. Epub 2010 Jan 7.
Clinical trial NCT04187248: The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Official title: The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 1248
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children with ALL, aged 1-17.9 years at time of diagnosis

Brief summary: Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.

Detailed description: Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.

In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.

This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.

Eligibility criteria: Inclusion Criteria:

* ALL, standard or intermediate risk
* Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
* Children (1-17,9 years at diagnosis)

Exclusion Criteria:

* ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
* \< 2 samples for asparaginase enzyme activity measurements

Primary outcomes:
measure: Number of participants with hypersensitivity
timeFrame: July 2008 - February 2016
measure: Number of participants with asparaginase associated pancreatitis
timeFrame: July 2008 - February 2016
measure: Number of participants with tromboembolism
timeFrame: July 2008 - February 2016
measure: Number of participants with osteonecrosis
timeFrame: July 2008 - February 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Pediatrics Skejby Hospital
state: Aarhus N
Study officials:
References:
Clinical trial NCT00505648: Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)
Official title: Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Drug Hypersensitivity
Keywords: Hypersensitivity
Syndrome
Tegeline
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-07-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Cutaneous and/or mucous eruption
* Polyadenopathy
* Body temperature \> 38°C
* Hematology disorders : Hypereosinophily \> 1.5 G/l, lymphocytosis \> 5G/l, atypical blood lymphocytes
* Consent obtained from patient

Exclusion Criteria:

* Age \< 18
* No consent obtained from patient
* IgV allergy
* Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
* Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
* IgA deficiency,
* MCI \>=35
* Sharp renal insufficiency before Dress with creatinaemia \< 60 ml/min (Cockroft)

Primary outcomes:
measure: express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH-rouen
state: Seine maritime
city: Rouen
country: France
facility: JOLY
Study officials:
affiliation: Clinique Dermatologique - Hôpital Charles Nicolle
name: Pascal JOLY, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: