louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01043094: Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
Official title: A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Renal Impairment
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):

The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.


Eligibility criteria: Inclusion Criteria:

* Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
* Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis \[if able to pass urine\]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject is on maintenance hemodialysis.
* Subject has a BMI of \>37 kg/m2.

Primary outcomes:
measure: Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 3 Days
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT05390294: Survival With Patients Treated With Salivary Gland Cancer
Official title: Prognostic Factors for Survival of Patients With Salivary Gland Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salivary Gland Cancer
Salivary Gland Neoplasms
Keywords: Salivary gland cancer
Survival
Prognostic factors
Lead sponsor: Clinical Center of Vojvodina
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated due to SGC in the Clinic for maxillofacial surgery at Clinical center of Vojvodina

Brief summary: Salivary gland malignancies is very heterogenous group of tumors regarding tumor histology and localization. The aim of this study is to assess main clinical and pathological parameters related to patients survival

Detailed description: The retrospective study enrolled medical charts of the patients treated due to salivaly gland cancers in the Clinic for maxillofacial surgery at Clinical center of Vojvodina in the period of 1. January 1996. to 31. December 2021. Patients demographics, type of the tumor, localization, TNM status and patohystological parameters were evaluated for patients survival and disease free periods

Eligibility criteria: Inclusion Criteria:

Patients with salivary gland malignancies treted in the Clinic for maxillofacial surgery

Exclusion Criteria:

Incomplete medical data Patients with metastatic tumord of salivary gland Patients with recurrent malignancies of salivary glands sent from other clinics

Primary outcomes:
measure: Patients survival
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Clinic for maxillofacial surgery Clinical center of Vojvodina
Study officials:
References:
Clinical trial NCT00966394: Salivary Bacteria and Oral Health Status in Children With ADHD
Official title: Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorders
Caries, Dental
Xerostomia
Keywords: ADHD, saliva, caries
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with ADHD, treated by medications or not, treated in the neurologic clinic at Hadassah.

The control are healthy children visiting the pediatric dental clinic at Hadassah.

Brief summary: Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies reported higher prevalence of caries and restorations among children with ADHD. Methylphenidate is the drug of choice to treat ADHD. according to the medical literature methylphenidate can cause xerostomia.

Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer capacity), oral hygiene and diet habits and their influence on caries among children with ADHD and among healthy children.

Our hypothesis is:

* Children with ADHD will have more caries.
* Children with ADHD will have more detrimental oral hygiene and diet habits.
* There will be a difference in the saliva parameters between children with ADHD and healthy children.


Eligibility criteria: Inclusion Criteria:

* test group- diagnosis of ADHD.
* control group- ASA1

Exclusion Criteria:

* control group
* administration of medicine at the time of the check-up.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah school of dental medicine
Study officials:
References:
Clinical trial NCT00018694: Cholestanol in Humans
Official title: Biologic Significance of Cholestanol in Man
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebrotendinous Xanthomatosis
Keywords: bile acid synthesis
chenodeoxycholic acid
sterol 27-hydroxylase
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED

Brief summary: The treatment of cerebrotendinous xanthomatosis an in born error of bile acid synthesis with chenodeoxycholic acid. Patients with this disease over produce cholestanol and bile acid precursors because of the block in synthesis. Replacement with chenodeoxycholic acid shut down abnormal pathway and reduces elevated level of cholestanol and improves the clinical syndrome.

Detailed description: Cerebrotendinous xanthomatosis is a recessively inherited in born of bile acid synthesis due to a mutation in sterol 27-hydroxylase (CYP27A1). Patients with this disease suffer from xanthomas located in the brain and tendon, accelerated atherosclerosis progression neurologic disease and cataracts. Plasma cholesterol levels are normal but cholestanol and C-27 bile alcohol that precursor of bile acid synthesis accumulate and are believe are responsible for the atherosclerosis, xanthomas and neurologic disease. Analysis of the bile reveal a severe sufficiency of the primary bile acid chenodeoxycholic acid that can not be produce because of the inherited defect. However, replacement of chenodeoxycholic acid in the enterohepatic pool inhibit abnormal bile acid synthesis and reduces the elevated level of cholestanol and C-27 bile alcohol this therapy halt the neurologic disease and prevents symptomatic atherosclerosis developing.

Eligibility criteria: Inclusion Criteria:

Patients with clinical and biochemical findings of cerebrotendinous xanthomatosis. Elevated levels of serum cholestanol and bile acid precursors.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: East Orange
country: United States
facility: VA New Jersey Health Care System, East Orange
state: New Jersey
Study officials:
affiliation: VA New Jersey Health Care System, East Orange
name: Gerald Salen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00819494: Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Official title: Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity
Keywords: Contrast media skin test
Skin test
hypersensitivity
contrast media
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 63
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.


Eligibility criteria: Inclusion Criteria:

1. Patients with history of immediate hypersensitivity reactions to iodinated contrast media
2. 15-70 years of age

Exclusion Criteria:

1. On antihistamine/ cannot discontinue antihistamine before the test
2. Having asthma exacerbation
3. Being pregnant
4. Suffering from severe systemic disease/ in bad health

Primary outcomes:
measure: Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media
timeFrame: 5 months
Secondary outcomes:
measure: Blood in vitro test from patients with a history of immediate reactions to radiocontrast media
timeFrame: 5 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01521494: PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease Requiring Hemodialysis
Keywords: Hemodialysis
Hyperphosphatemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 183
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.


Eligibility criteria: Inclusion Criteria:

* Patients age 20 or older, regardless of gender.
* Receiving stable maintenance hemodialysis 3 times a week.
* Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.

Primary outcomes:
measure: Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change From Baseline in Serum Calcium Concentrations.
timeFrame: 6 weeks
measure: Change From Baseline in Serum Intact-PTH Concentrations.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Department, Kissei pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
Clinical trial NCT01126294: Perioperative Melatonin in Lumbar Laminectomy
Official title: Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.
Keywords: lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 84
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: Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.


Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years old
* ASA status 1-3
* having lumbar laminectomy 2 to 3 levels with or without fusion

Exclusion Criteria:

* receiving emergent procedure
* surgery for neoplastic spine lesion
* allergy to melatonin or its non-medicinal ingredients
* allergy or contraindication
* BMI over 35 or or less than 20 kg/m2
* pregnancy or breastfeeding
* failure to provide informed consent

Primary outcomes:
measure: Pain
timeFrame: 24 hours
measure: Anxiety
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Philip Peng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.
Clinical trial NCT00907894: Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Official title: A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B,
telbivudine,
pharmacokinetics,
safety,
tolerability,
pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents patients
* HBsAg seropositive

Exclusion criteria:

* Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
* Prior anti-HBV therapy within 30 days of study drug dosing.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
timeFrame: 6 days
Secondary outcomes:
measure: Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
timeFrame: 6 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigator Site
city: Starnberg
country: Germany
facility: Novartis Investigator Site
city: Wuppertal
country: Germany
facility: Novartis Investigator Site
city: Manila
country: Philippines
facility: Novartis Investigator Site
city: Quezon City
country: Philippines
facility: Novartis Investigator Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.
Clinical trial NCT02869594: Institut Paoli Calmettes Prostate Cancer Database
Official title: Institut Paoli Calmettes Prostate Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostatic Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 10000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Prostate Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer


Eligibility criteria: Inclusion Criteria:

* Prostatic cancer

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT03427294: Delphi Study on Rehabilitation Following Lumbar Arthrodesis
Official title: Delphi Study on Rehabilitation Following Lumbar Arthrodesis in UZ Leuven (Belgium)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spine Degeneration
Physical Disability
Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: UHasselt
name: KU Leuven
First posted: 2018-02-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Brief summary: Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.

Detailed description: The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.

Eligibility criteria: Inclusion Criteria:

* The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Duration of perioperative rehabilitation following lumbar arthrodesis
timeFrame: January - December 2018
measure: Physiotherapeutic content following lumbar arthrodesis
timeFrame: January - December 2018
measure: Frequency of physiotherapeutic intervention following lumbar arthrodesis
timeFrame: January - December 2018
measure: Multidisciplinary character of perioperative rehabilitation following lumbar arthrodesis
timeFrame: January - December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ/KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bart Depreitere, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Thijs Swinnen, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Tinne Thys, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Dankaerts, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Simon Brumagne, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Van Wambeke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Lieven Moke, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sebastiaan Schelfaut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ann Spriet, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Lotte Janssens, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: