louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01889290: Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
Official title: Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Use, Unspecified With Other Opioid-induced Disorder
Keywords: methylnaltrexone
opioid-antagonist
Obstipation
pharmacokinetics
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
* Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
* Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
* Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
* Trial with medicinal product

Detailed description: After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.

Eligibility criteria: Inclusion criteria:

* hospitalisation in the neurointensive care unit
* deep sedation with sufentanil doses of = 40 mcg/h
* male or female aged 18 years or older
* females: negative pregnancy test
* Ventricular drainage as part of needed therapeutic measures

Exclusion criteria:

* History of hypersensitivity to methylnaltrexone (Relistor®)
* confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
* increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
* severe hepatic insufficiency (Child-Pugh Class C)
* renal impairment (glomerular filtration rate \< 90 ml/min) with or without renal replacement therapy
* severe diarrhea despite high opioid dosing
* participation in another study with an investigational drug within the 30 days preceding and during the present study

Primary outcomes:
measure: Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Neurointensive Care Unit
Study officials:
affiliation: University Hospital Zurich, Pharmacology and Toxicology
name: Natascia Corti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01648790: A Study of Prasugrel in Healthy Participants
Official title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2012-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Detailed description: The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* No known allergies to Prasugrel or related compound
* No regular alcohol intake greater than 21 units per week for males or 14 units per week for females

Primary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
timeFrame: Predose through 8 Hours Post Dose
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
timeFrame: Predose through 8 Hours Post Dose
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
timeFrame: Predose through 8 Hours Post Dose
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
timeFrame: Predose through 8 Hours Post Dose
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT07017790: Amino Acid PET to Assess the Efficacy of IDH Inhibitor Treatments for IDH Mutated Gliomas
Official title: Amino Acid PET Imaging to Assess the Efficacy of IDH Inhibitor Treatments for Patients With Refractory IDH Mutated Gliomas
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent amino acid PET for early assessment of therapeutic response of IDH-mutated gliomas under anti-IDH treatment between February 2022 and November 2024

Brief summary: Amino acid PET imaging could represent a biomarker for the evaluation of IDH inhibitor treatments for patients with refractory IDH-mutated gliomas

Detailed description: Amino acid PET imaging could represent a biomarker for the evaluation of IDH inhibitor treatments for patients with refractory IDH-mutated gliomas In fact, this study will allow us to assess, using Rano 1.0 criteria for PET and Rano 2.0 criteria for MRI, which of the two examinations is most effective in assessing the efficacy of anti-IDH treatment patients with refractory IDH-mutated gliomas.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent amino acid PET for early assessment of therapeutic response of IDH-mutated gliomas under anti-IDH treatment between February 2022 and November 2024

Exclusion Criteria:

* Individuals who have objected to the use of their data

Primary outcomes:
measure: Compare the performance between amino acid PET and brain MRI to assess a treatment efficacy
timeFrame: one day
Secondary outcomes:
measure: Compare the performance between amino acid PET and brain MRI to assess a treatment efficacy for the identification of lesions
timeFrame: one day
Other outcomes:
Locations:
city: Vandoeuvre/les/Nancy
country: France
facility: CHRU of NANCY
Study officials:
References:
Clinical trial NCT06209203: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients with Corneal Epithelial Defects After TPRK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Epithelium Defect
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.

Detailed description: Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.

Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.

Eligibility criteria: Inclusion Criteria:

1. Age of 18-40 years old, regardless of gender;
2. Plan TPRK for myopia and/or myopic astigmatism, meet the indications for TPRK, and set the ablation diameter of the optical zone at 6.0-6.5 mm;
3. Schirmer test I ≥10mm/5min;

Exclusion Criteria:

1. prior corneal refractive surgery or keratoplasty;
2. Contraindications to TPRK surgery, including severe ocular surface disease that may affect the corneal epithelium, active ocular inflammation, moderate to severe dry eye, keratoconus or other types of corneal ectasia, thin corneas, severe lesions of ocular appendages (such as eyelid defects, deformations, etc.), glaucoma, cataract that affects vision, History of systemic immune diseases (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.);
3. incomplete eyelid closure;
4. corneal degeneration, corneal stroma or endothelial damage or malnutrition;

Primary outcomes:
measure: healing time
timeFrame: seven days
Secondary outcomes:
measure: number of healing
timeFrame: seven days
Other outcomes:
measure: Corneal staining
timeFrame: seven days
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Xingtao Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901403: Earned Income Tax Credit Access Study
Official title: Earned Income Tax Credit Access Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Study is Intended to Increase Take-up of EITC
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The EITC Access Study an intervention study provided to families in 7 counties in Michigan.The intervention involves appending a concentrated benefits advocacy intervention onto an existing home visiting program. There are 5 treatment counties and 2 control counties that will survey families in the home visiting program to compare the relative benefits of the added benefits advocacy intervention on the outcomes of parent mental health, intimate partner violence, economic hardship, earned income tax credit take-up, and child maltreatment.


Eligibility criteria: Inclusion Criteria:

* 18 years of age, has a child in their home

Exclusion Criteria:

* Does not speak or read English, Spanish, Burmese, or Arabic

Primary outcomes:
measure: Earned Income Tax Credit receipt
timeFrame: Within 2 years of receiving the intervention
Secondary outcomes:
measure: Child maltreatment behaviors
timeFrame: Within 2 years of receiving the intervention
measure: Intimate partner violence
timeFrame: Within 2 years of receiving the intervention
measure: Depression
timeFrame: Within 2 years of receiving the intervention
measure: Anxiety
timeFrame: Within 2 years of receiving the intervention
measure: Economic hardship
timeFrame: Within 2 years of receiving the intervention
Other outcomes:
Locations:
city: Battle Creek
country: United States
facility: Calhoun Intermediate School District
state: Michigan
city: Belleville
country: United States
facility: SOS Community Services
state: Michigan
city: Croswell
country: United States
facility: Sanilac Intermediate School District
state: Michigan
city: Houghton
country: United States
facility: Keweenaw Family Resource Center
state: Michigan
city: Kalamazoo
country: United States
facility: Catholic Charities Diocese of Kalamazoo
state: Michigan
city: Marysville
country: United States
facility: St Clair RESA
state: Michigan
city: Portage
country: United States
facility: Kalamazoo KRESA
state: Michigan
Study officials:
References:
Clinical trial NCT00134303: Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity
Official title: Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-08-24
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

Detailed description: In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically defined according the Brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.

Eligibility criteria: Inclusion Criteria:

* Patients receiving bariatric surgery for obesity

Exclusion Criteria:

* Other causes of liver disease (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], primary biliary cirrhosis \[PBC\], etc.)
* Patients with diabetes type I
* Patients with endocrinological reasons for obesity (eg. Cushing, etc.)

Primary outcomes:
measure: Number of patients with histological amelioration of NASH after a period of 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hans Van Vlierberghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04124003: A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin
Official title: An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Women must not be of childbearing potential (WNOCBP)
* Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
* Any major surgery within 4 weeks of study drug administration
* Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
* Previous treatment with BMS-963272
* Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1

Other protocol-defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: up to Day 10
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)
timeFrame: up to Day 10
measure: Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
timeFrame: up to Day 10
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Approximately 50 days
measure: Number of significant changes in lab assessments of blood serum
timeFrame: Approximately 50 days
measure: Number of significant changes in lab assessments of blood
timeFrame: Approximately 50 days
measure: Number of significant changes in lab assessments of urine
timeFrame: Approximately 50 days
measure: Blood pressure
timeFrame: Approximately 50 days
measure: Body temperature
timeFrame: Approximately 50 days
measure: Respiratory rate
timeFrame: Approximately 50 days
measure: Number of Participants with abnormal physical examination findings
timeFrame: Approximately 50 days
measure: Heart rate
timeFrame: Approximately 50 days
measure: Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
timeFrame: Approximately 50 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Salt Lake
state: Utah
Study officials:
References:
Clinical trial NCT01621503: Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Official title: Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-06-18
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed description: Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.

Eligibility criteria: Inclusion Criteria:

1. IOP Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma
2. CCT Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma 3. Possible to participate in the study regardless of existence of corneal diseases (such as Keratoconus, post-LASIK, and corneal scars)

Exclusion Criteria:

1. IOP Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Those with corneal scarring or who have had corneal surgery such as laser surgery 4. Microphthalmus 5. Buphthalmos 6. Contact lens wearers 7. Dry eyes 8. Blepharospasm 9. Nystagmus 10. Keratoconus 11. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 12. Those with central corneal thickness greater than 600 μm or less than 500 μm 13. A subject judged to be ineligible for participating in the study by the physicians in charge
2. CCT Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Blepharospasm 4. Nystagmus 5. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 6. A subject judged to be ineligible for participating in the study by the physicians in charge

Primary outcomes:
measure: central corneal thickness
timeFrame: one day
measure: intraocular pressure
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu city
country: Japan
facility: Kaiya ophthalmological clinic
state: Shizuoka
city: Tokyo
country: Japan
facility: Ochanomizu Inoue ophthalmological clinic
Study officials:
References:
Clinical trial NCT00944203: Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis
Official title: Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Jellyfish Dermatitis
Jellyfish Venoms
Keywords: jellyfish
jellyfish venom
jellyfish dermatitis
jellyfish stings
Ipomea pes-caprae
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive standard medical treatment depend on the severity of the disease. The doctor will divide the dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as an add-on therapy to the "test area", while the ointment will not be applied to the "control area". Patients will be asked to come for follow up 6 times in the 28-days study period. Primary objective is to compare the healing time of dermatitis in both areas.

Detailed description: The "Test area" and "Control area" are allocated in each participant. We use the Internal Control fashion. The healing time of each area will be collected as an outcome measure.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of jellyfish dermatitis
* total lesion area is more than 4 square centimeter

Exclusion Criteria:

* expose to jellyfish more than 7 days
* severe systemic reaction to jellyfish
* allergy to Ipomea pes-caprae or the component of the ointments

Primary outcomes:
measure: Healing time of the Jellyfish dermatitis lesion (days)
timeFrame: Follow up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University
Study officials:
affiliation: Mahidol University
name: Watcharapong Piyaphanee, MD
role: PRINCIPAL_INVESTIGATOR
References: