louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785772: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Official title: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Impairment
Keywords: Gabapentin Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

Detailed description: Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Eligibility criteria: Inclusion Criteria:

* Japanese epilepsy patients with renal impairment

Exclusion Criteria:

* NA

Primary outcomes:
measure: Observed Plasma Gabapentin Concentration
timeFrame: Days 8 and 15
measure: Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
timeFrame: Days 8 and 15
measure: Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
timeFrame: Days 8 and 15
Secondary outcomes:
Other outcomes:
Locations:
city: Saijyo-shi
country: Japan
facility: Pfizer Investigational Site
state: Ehime
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02209272: Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia
Official title: Local Anesthesia for Ultrasound Guided Hip Joint Injections: A Double-Blinded Randomized Controlled Trial of Bacteriostatic Saline Versus Buffered Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip injections.

Detailed description: Local anesthesia is commonly used to reduce pain during joint injections, particularly for deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most medical practices. It is well known that lidocaine infiltration itself is painful. Many strategies have been studied to minimize pain associated with lidocaine administration, including buffering, warming, and slowing infiltration rate. BS is an alternative local anesthetic that has been shown to be less painful when injected into subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented for local anesthesia, and it has not been studied in the context of joint injections.

Eligibility criteria: INCLUSION CRITERIA:

* age 18-75 years
* referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine \& Rehabilitation Clinic, or Musculoskeletal Clinic

EXCLUSION CRITERIA:

* chronic opioid use
* opioid use on day of procedure
* history of fibromyalgia or other diffuse chronic pain syndrome
* pain behavior during the clinical encounter as judged by the injectionist
* anesthetic administration time outside the designated 5-15 second time frame

Primary outcomes:
measure: VAS for Pain Score During Local Anesthesia Infiltration
timeFrame: baseline to 5-10 minutes later -- immediately after local anesthetic injection administration
Secondary outcomes:
measure: VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)
timeFrame: baseline to 5-10 minutes later -- immediately after hip joint injection
measure: Anesthetic Infiltration Duration
timeFrame: baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jacob Sellon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04113772: Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
Official title: Orfadin and Nitinosine Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary Tyrosinemia, Type I
Lead sponsor: Sutphin Drugs
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg

Detailed description: Detailed Description:

The specific aim is to conduct a randomized, single dose, three-period crossover bioequivalence study in at least 18 healthy male and female subjects at a single study center to evaluate the in vivo performance of two formulations of Nitisinone 10 mg and the reference product Orfadin under fasting.

A total of 4 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to a treatment sequence, before administration of investigational nitinosine

Determination of succinylacetone (SA) in blood (serum/plasma) and/or urine will be performed. Results from samples analyzed at the central laboratory, including determination of nitisinone, will be used in the evaluation of pharmacokinetics, efficacy and safety during the two treatment periods.

Eligibility criteria: Inclusion Criteria:

* All HT-1 patients receiving Orfadin treatment are eligible for entry.
* Male and female patients of all ages diagnosed with HT-1.
* Stable lab values, including liver values \<2 ULN (ALP, ALT, AST, bilirubin, INR).
* Women of childbearing potential willing to use adequate contraception
* Signed informed consent/assent.

Exclusion Criteria:

* Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
* Enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study.
* Pregnant women.
* Lactating women. .Known hepatitis B, hepatitis C or HIV infection.
* Foreseeable inability to cooperate with given instructions or study procedures.

Primary outcomes:
measure: Succinylacetone level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Navsari
country: India
facility: Lifein Multi-Specialty Hospital
state: Gujarat
Study officials:
References:
Clinical trial NCT05543772: Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
Official title: Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line (Indwelling Line): a Technique to Keep Optimal Specimen After Fluid Flush
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Emergencies
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background: Peripheral Intravenous catheter (PIVC) is a frequently used device for intravascular access. It is usually indicated to administer intravenous fluid and medications. However, the investigators could possibly utilize this line for blood sampling even after using it as a fluid port.

Detailed description: Aims: To investigate the quality of previously flushed PIVC sample and the effectiveness of the withdrawal technique.

Methodology: Study will be held in King Fahad University Hospital during a year after obtaining the IRB approval. Selection of study participants will be depending on their health status and the investigators will exclude pediatric participants. Two blood samples will be collected from participants. First one is after the insertion of the intravenous peripheral line. The second is after fluid infusion through the same line. Samples will be sent to the laboratory then. Results will be collected and analyzed.

The importance of the research: If this type of sampling can be standardized , this means there will be less insertions to the patients, less adverse effects in relation to the number of insertions, fast and preexisted intravascular access for sampling so the time can be saved in critical conditions.

Eligibility criteria: Inclusion Criteria:

* It will include healthy adult volunteers.

Exclusion Criteria:

* Pediatric patients and critically ill patients will be excluded from the study

Primary outcomes:
measure: Comparison of pCO2, pO2 (mmHg) Before and After IV Fluid Infusion in Healthy Adults
timeFrame: 1 year
measure: Comparison of PH Before and After IV Fluid Infusion in Healthy Adults
timeFrame: 1 year
measure: Comparison of ctHb (g/dL) Before and After IV Fluid Infusion in Healthy Adults
timeFrame: 1 year
measure: Comparison of SO2, FO2Hb, FCOHb, FMetHb (%) Before and After IV Fluid Infusion in Healthy Adults
timeFrame: 1 year
measure: Comparison of cBase(Ecf)c, cHCO,-(P.st)c, cNa, cK, cCl, cCa (mmol/L) Before and After IV Fluid Infusion in Healthy Adults
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Khobar
country: Saudi Arabia
facility: King Fahd University Hospital
state: East
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Dunya N Alfaraj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926272: Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
Official title: Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Alzheimer's disease is a neurodegenerative disease. Numerous studies have reported that β-amyloid (Aβ) is an important marker for the diagnosis of AD. 18F-92 molecular probe is a novel molecularly targeted imaging agent, which can rapidly penetrate the blood-brain barrier and has high affinity and selectivity for Aβ protein. In this study, 18F-92 PET/CT was used to monitor the regional distribution and the degree of deposition in patients with Alzheimer's disease, and compared with clinical symptoms (neuropsychometry) to evaluate its application value in the diagnosis of AD.

Detailed description: Healthy volunteers as well as patients meeting Alzheimer's criteria will be recruited for this study.

We will use PET/CT imaging technology to scan each participant's whole body or head and collect image data for analysis to evaluate the distribution and metabolism of 18F-92 in the subject's body. Time from drug injection to scan completion is approximately 1 hour.

Eligibility criteria: Inclusion Criteria:

* Patients or their families complain of significant memory impairment;
* Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
* Meets Alzheimer's criteria for DSMIV and NINCDS-ADRDA;
* Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
* Signed written consent.

Exclusion Criteria:

* Nervous system diseases: including brain tumors, craniocerebral trauma, multiple sclerosis, epilepsy, etc.;
* Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
* Pregnancy or lactation.

Primary outcomes:
measure: standardized uptake value ratio (SUVR)
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Aβ42 in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: t-tau in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: p-tau in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: MMSE (Mini-mental State Examination)
timeFrame: Within 2 hours prior to tracer injection
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Within 2 hours prior to tracer injection
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT03838172: Investigation of the Impact of Burn Injury on Parents
Official title: The Effects of Burn Injury on Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Parents
Keywords: Burn Injury
quality of life
scar
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents who have a burned child

Brief summary: Burn injuries are related to longer hospital stay. Patients who have a burned child are affected prolonged hospitalization. Social life and quality of life are affected by burn injuries. Therefore, the aim of this study is to investigate the effects of burn injury on parents.

Detailed description: Pediatric burn injuries is commonly seen. Burn injuries are extended from minor injuries to severe injuries. The severity of burn injury may affect burn related complications such as scar tissue and duration of hospitalization. This process extremely affect parents. Although parents are part of this prolonged treatments process, there is no study that evaluated of the impact of burn injury on parents. Therefore, the aim of this study is to investigate the effects of burn injury on parents.

Eligibility criteria: Inclusion Criteria:

* Parents who have a burned child
* Parents who have a volunteer

Exclusion Criteria:

* Parents who have no confirm to participate this study

Primary outcomes:
measure: Family of Impact scale
timeFrame: 15 minutes
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: 15 minutes
measure: The hospital anxiety and depression scale
timeFrame: 15 minutes
measure: The Spielberger State-Trait Anxiety Inventory
timeFrame: 15 minutes
measure: Patient and Observer Scar Assessment Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozden Ozkal
Study officials:
References:
Clinical trial NCT05434572: CIMR Neuromuscular Research Biobank
Official title: Center for Inherited Muscle Research Neuromuscular Research Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Diseases
Neuromuscular Disorder
Neuromuscular Diseases in Children
Keywords: Neuromuscular
Research Repository
Biobank
Neuromuscular Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 500
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a very inclusive study that will allow samples from known subjects of sites' neuromuscular clinics, associated family members, and healthy volunteers. This study will include subjects with any form of neuromuscular disorder, including neuromuscular disorders of unknown etiology.

Brief summary: The purpose of this research repository is to collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate. These samples will be stored at Virginia Commonwealth University (VCU) and will be used for future research with this population.

Detailed description: The study involves collection of medical information about research participants and their families. No identifying information about family members will be collected. Research participants will be asked for any general knowledge they have related to possible neurological disorders.

Research participants are also given the opportunity to provide blood, skin cells, urine, saliva, fecal matter, muscle tissue, cells, DNA and/or RNA samples.

Before any study procedures take place, the informed consent form will be provided and reviewed with potential research participants in detail. Potential research participants will have an opportunity to ask additional questions before starting any study procedures.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent
* Positive diagnosis or suspected diagnosis of neuromuscular disease, or
* Family history of neuromuscular disease, or
* Healthy volunteer
* Age Neonates-75

Exclusion Criteria:

* Unwilling to sign consent

Primary outcomes:
measure: To collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate.
timeFrame: Baseline
Secondary outcomes:
measure: To collect medical history information from subjects with all types of neuromuscular disease and healthy controls.
timeFrame: Baseline
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nicholas E. Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211572: The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers
Official title: Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The clinical trial will be a prospective, two-strata, non-blinded, single institution Health Canada approved window of opportunity trial with 2 weeks of pre-surgical endocrine therapy using either anastrozole or tamoxifen.
Primary purpose: OTHER

Brief summary: Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Detailed description: The clinical trial will be a prospective, two strata, non-blinded, single institution, Health Canada approved, Window of Opportunity trial with 2 weeks of pre-surgical endocrine therapy using either anastrozole or tamoxifen. Tissue from the initial biopsy and from surgery will be sent for Ki67 analysis using the NanoString® Assay.

Eligibility criteria: Inclusion Criteria:

* Any patient with histologically confirmed newly diagnosed operable ER+, Her2 negative invasive carcinoma on diagnostic core biopsy that has a radiographic size ≥ 1.5 cm
* Histology has to be ductal, lobular or mixed
* Surgery date planned in the next 2-6 weeks
* Negative pregnancy test if of child baring potential
* Post-menopausal status verified by FSH and Estradiol (with 6 months of amenorrhea)

Exclusion Criteria:

* Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months
* Known metastatic or recurrent breast cancer.

Primary outcomes:
measure: Endocrine Therapy response
timeFrame: at one year
Secondary outcomes:
measure: Biomarker Predictive value
timeFrame: at one year
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital
name: Angel Arnaout, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01121172: Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)
Official title: Serum Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)in Obese Children and Adolescents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Insulin Resistance
Diabetes Mellitus Type 2
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 obese children 40 obese adolescents 50 lean children 50 lean adolescents

Brief summary: The aim of this study is to investigate serum apelin levels as well as their possible association with G212A polymorphism of the apelin receptor in obese children and adolescents.

So far apelin has been reported to be involved in the pathophysiology of various heart diseases such as cardiomyopathies and heart failure. According to recent reports in adults apelin seems to be associated with impaired glucose metabolism, particularly in newly diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The researchers will try to investigate the role of this new adipokine in order to early detect and to prevent similar entities in childhood obesity.


Eligibility criteria: Inclusion Criteria:

* Obese children and adolescents (aged 2-16 years old)

Exclusion Criteria:

* Chronic diseases
* Hypothyroidism
* Medication

Primary outcomes:
measure: Serum Apelin Levels
timeFrame: First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning
Secondary outcomes:
measure: Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents
timeFrame: First day after enrollment
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Study officials:
References: