louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02110316: Bioavailability of Voriconazole
Official title: Bioavailability of Voriconazole in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Voriconazole
Bioavailability
Critically Ill
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to obtain the absolute bioavailability of voriconazole in critically ill ICU patients, because pharmacokinetics can be different in critically ill patients due to alterations in function of various organs and body systems compared with healthy volunteers.

Detailed description: The bioavailability of voriconazole, based on healthy volunteers, is estimated to be \>90%. Due to the high bioavailability of voriconazole, switching between oral and intravenous administration is permitted if clinically allowed. Few data are available for the bioavailability of voriconazole in critically ill patients. However, to obtain a therapeutic concentration of voriconazole (\>1.5 mg/L, which is associated with a beneficial response to treatment) one study showed that a higher oral dose is required compared with the intravenous dose, to obtain this therapeutic concentration. Therefore, the pharmacokinetics can be changed in critically ill patients, including bioavailability.

In this study, patients who receive voriconazole orally (prescribed by their attending physician) will receive one intravenous dose of voriconazole instead of the oral dose. The intravenous dose will be the same as the oral dose voriconazole.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 yrs;
* Treatment with voriconazole;
* Admission to an ICU;
* Written informed consent.

Exclusion Criteria:

* Blood sampling by central venous catheter or peripheral cannula not possible;
* Concomitantly using a strong inhibitor or inducer of cytochrome P450.

Primary outcomes:
measure: The bioavailability of voriconazole in critically ill patients
timeFrame: 1 day
Secondary outcomes:
measure: Correlation of bioavailability of voriconazole with disease severity
timeFrame: 1 day
measure: Correlation of bioavailability of voriconazole with the degree of inflammation
timeFrame: 1 day
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jan-Willem Alffenaar, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969716: Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Geriatric Parameters
Official title: Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Detailed Geriatric Assessment Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Old Age; Debility
Lead sponsor: Sultan 1. Murat State Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-14
Enrollment: 420
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study

Brief summary: The aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 80 and above
* Patients with complete detailed geriatric assessment parameters

Exclusion Criteria:

* Presence of neurodegenerative disease (dementia, parkinsonism)
* Immobilized patient
* Those who have had an acute illness (infection, fracture, cerebrovascular disease) in the last month
* Having psychotic disorders
* Having severe hearing loss

Primary outcomes:
measure: Presence of fibromyalgia syndrome
timeFrame: Baseline
Secondary outcomes:
measure: Neurocognitive assessment
timeFrame: Baseline
measure: Mood assessment
timeFrame: Baseline
measure: Daily living activities
timeFrame: Baseline
measure: Balance and walking assessment
timeFrame: Baseline
measure: Nutritional assessment
timeFrame: Baseline
measure: Frailty
timeFrame: Baseline
measure: Activities of daily living
timeFrame: Baseline
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Sultan 1. Murat State Hospital
Study officials:
affiliation: Sultan 1. Murat State Hospital
name: Kübra Altunkalem Seydi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737216: Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Aged
patients
Lead sponsor: Hebei Tumor Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Age ≥70 years
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically or cytologically confirmed lung cancer
* Did not receive bisphosphonate treatment

Exclusion Criteria:

* Appear relapse and metastasis
* receive other bisphosphonate treatment
* Active or uncontrolled infection
* Pregnant or lactating women

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
measure: Bone mineral density(BMD)
timeFrame: 1 year
measure: Quality of life(QOL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Tumor Hospital
state: Hebei
Study officials:
affiliation: Hebei Tumor Hospital
name: Wei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02678416: Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
Official title: A Randomized, Placebo-Controlled, Double-Blind, Two-Part, Cross-over Study in Healthy Adult Male Subjects to Compare the Reduction in Pain Intensity After Single-Dose Administration of Intravenous or Oral Acetaminophen and Intravenous Morphine by Using UVB Burn and Intradermal Capsaicin Experimental Pain Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: comparison
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 79
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity.

The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.


Eligibility criteria: Inclusion Criteria

1. Must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations.
2. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the screening.
3. Must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110 pounds (50 kg) at screening.

Exclusion Criteria

1. A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
2. A history of any drug allergy, hypersensitivity, or intolerance to acetaminophen, morphine, or capsaicin or to any of the excipients in the IV or oral formulations used.
3. A positive test result for drugs of abuse, alcohol, or cotinine.
4. Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.
5. A history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
6. Any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Primary outcomes:
measure: Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
timeFrame: within 6 hours
Secondary outcomes:
measure: Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
timeFrame: within 6 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pharmaceuticals Research Associates, Inc. (PRA)
state: Utah
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT02575716: Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
Official title: Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscle Relaxant
Keywords: McGrath®
Videolaryngoscope
intubating condition
muscle relaxant
intubation
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant

Detailed description: Thirty-four patients with ASA classification I-II, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the patients were fully relaxed. The primary outcome was to compare tracheal intubating conditions between two groups. The secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. Statistical analyses were performed using the R program version 2.14.2. The level of statistical significance was set at p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old.
* ASA class I-II.
* Elective surgery required general anesthesia with oroendotracheal intubation

Exclusion Criteria:

* Suspected or known difficult airway.
* Patient with risk of aspiration with required of rapid sequence induction .
* Plan remained intubation.
* Allergic to drugs used in the study.
* Renal or hepatic disease.

Primary outcomes:
measure: Intubating condition.
timeFrame: one year
Secondary outcomes:
measure: Success rate in the first attempt intubation.
timeFrame: one year
measure: Time to intubation
timeFrame: One year
measure: The required propofol dose for intubation without muscle relaxant.
timeFrame: one year
measure: Events during the intubation attempts occurred.
timeFrame: one year
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Department of anesthesiology
state: Songkla
Study officials:
affiliation: Prince of Songklanagarind University
name: Piyaporn Vasinanukorn, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT03847116: Alcohol Consumption and Type 2 Diabetes Mellitus Risk in Nonalcoholic Fatty Liver Disease
Official title: Association of Light-to-moderate Alcohol Consumption With Risk of Type 2 Diabetes Mellitus in Individuals With Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver Disease
Light-to-moderate Alcohol Consumption
Type2 Diabetes Mellitus
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 14014
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: Consecutive Chinese adults underwent annual health examinations in 2009 were enrolled in the cohort study. Follow-up between 2009 and 2018 were obtained in Zhenhai Lianhua Hospital, Ningbo.

Brief summary: This study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD).


Eligibility criteria: Inclusion Criteria:

1. aged 18 years or above
2. undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China.
3. informed about the study

Exclusion Criteria:

1. female participants;
2. missing data on ultrasound, alcohol consumption, and T2DM status;
3. alcohol consumption \> 210 g per week, and binge drinkers;
4. with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.

Primary outcomes:
measure: Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM)
timeFrame: cross-sectional analyses in 2009
Secondary outcomes:
measure: LMAC and incident risk of T2DM
timeFrame: 9-year cohort observation
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
citation: Xu L, Xie J, Chen S, Chen Y, Yang H, Miao M, Zhu Z, Li Y, Yu C, Xu C. Light-to-Moderate Alcohol Consumption Is Associated With Increased Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease: A Nine-Year Cohort Study. Am J Gastroenterol. 2020 Jun;115(6):876-884. doi: 10.14309/ajg.0000000000000607.
Clinical trial NCT03697616: Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR
Official title: Ridge Augmentation Using Autologous Concentrated Growth Factors (CGF) Enriched Bone Graft Matrix (Sticky Bone) Versus Guided Bone Regeneration Using Native Collagen Membrane in Horizontally Deficient Maxilla
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horizontal Deficiecy in Maxillary Arches
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Guided bone regeneration (GBR) using bone graft and barrier membrane is a well-established technique for augmentation of atrophic alveolar ridges. There are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws the stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential for success.

Detailed description: Common techniques introduced for horizontal ridge augmentation are Guided Bone Regeneration (GBR), there are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws. For successful GBR, stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential. Space maintenance with particulate bone graft should be provided during healing period. However particulate bone graft is easily migrated when grafted on the large horizontal bone defect. To reconstruct large bony defect or for the 3-dimensional ridge augmentation, bone tack on the collagen membrane or titanium mesh is required to contain particulate bone graft during healing but these procedures are surgically time consuming and technique sensitive.

Sticky bone is biologically solidified bone graft which is entrapped in fibrin network. Sticky bone graft doesn't scatter because particulate bone powders are strongly interconnected each other by fibrin network.

Eligibility criteria: Inclusion Criteria:

* Inadequate facial bone obviating prosthodontically planned implant placement in the maxilla
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Significant bone-related illness or pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally).

Primary outcomes:
measure: Horizontal bone gain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03371316: Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies
Official title: Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemicraniectomies
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients requiring a hemicraniectomy will also receive the amnion patch as an anti-adhesive barrier
Primary purpose: TREATMENT

Brief summary: The goal of this study is to demonstrate that ViaShield™ amnion patch is effective in preventing fibroblast activity and hence soft tissue adhesions after a hemicraniectomy.

Detailed description: A hemicraniectomy is a surgical procedure in which part of the skull is temporarily removed to relieve pressure on the underlying brain. Hemicraniectomies are typically performed on patients experiencing severe brain injury, usually due to stroke or trauma. In these cases, the brain injury and swelling is so severe that it can lead to brain compression and brain death. As a result, a surgeon will remove the bone flap to help with brain swelling and increased intracranial pressure. After the patient heals, a cranioplasty will be performed to restore the bone flap to its original location.

When the central nervous system is deprived of its normal covering, as is the case with hemicraniectomies, the exposed area becomes the site of cellular reaction from surrounding tissue1 and soft tissue adhesions frequently develop between the skin flap and the dura mater or exposed brain, which may lead to less than optimal clinical outcome.

ViaShield™ is an amnion patch produced from human amniotic membrane. Because of its inherent anti-adhesive properties, amnion serves as an ideal barrier against scarring and soft tissue adhesions to the neural elements, anterior vessels and hardware.

Eligibility criteria: Inclusion Criteria:

18 years of age minimum Informed consent signed by patient or next of kin

Exclusion Criteria:

Immunosuppressive disorder

Primary outcomes:
measure: Adhesion
timeFrame: 4-8 months
Secondary outcomes:
measure: Infections
timeFrame: From time of surgery to 8 months post-operative
measure: hydrocephalus
timeFrame: From time of surgery to 8 months post-operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02025816: RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Soft Tissue Infections
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty to twenty five patients with necrotizing soft tissue infections (NSTI) admitted to the University Medical Center, Lubbock, TX

Brief summary: Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections

Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.


Eligibility criteria: Inclusion Criteria:

* Patient or LAR agrees to the procedure and signs informed consent form
* Patient is at least 18 yrs of age
* Patient has been diagnosed with an NSTI

Exclusion Criteria:

* Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis

Primary outcomes:
measure: Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI
timeFrame: 2-6 wks (duration of hospitalization)
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center/University Medical Center
state: Texas
city: Lubbock
country: United States
facility: University Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Kendra Rumbaugh, PhD
role: PRINCIPAL_INVESTIGATOR
References: