louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03780998: Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases
Official title: Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhoids
Anal Fissure
Perianal Fistula
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Tabriz University of Medical Sciences
First posted: 2018-12-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older than 18 years old cases

Brief summary: New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)

Detailed description: Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study.

Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases

Eligibility criteria: Inclusion Criteria:

* Grade 1 and 2 hemorroidal disease
* Cronic anal fissura
* Uncomplicated simple perianal fistula

Exclusion Criteria:

* Any malign tumour
* Cronic colorectal disases
* Routine used of vasoactive medication

Primary outcomes:
measure: Pain symtom differences
timeFrame: six months
measure: Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)
timeFrame: six months
measure: Closing of anal fissur line
timeFrame: six months
measure: Lowering of leakage amount of perianal fistule
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00766545: Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Official title: Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Infarction
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 1095
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.


Eligibility criteria: Inclusion Criteria:

1. Prior cerebral infarction Onset at 1 to 6 months before randomization
2. CT or MRI detection of responsible site
3. Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure)

Exclusion Criteria:

1. History of intracranial hemorrhage
2. Possibility of cardiogenic cerebral embolism in the past or future All patients with any of the following complications were excluded: mitral valve stenosis, prosthetic valve, endocarditis, myocardial infarction within 6 weeks after onset, ventricular aneurysm, intraventricular or intraatrial blood clots, mitral valve prolapsed (age under 45 years old, lacking other causes for cerebral embolism induction), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy
3. Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented
4. Contraindications to the study drug Hemostatic disorders or systemic bleeding Pregnant or possibly pregnant women, or nursing mothers
5. Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease

Primary outcomes:
measure: Recurrence of cerebral infarction
timeFrame: any time
Secondary outcomes:
measure: Cerebral infarction or myocardial infarction, Cerebral infarction, intracranial hemorrhage, or TIA, Cerebral infarction, intracranial hemorrhage, myocardial infarction, or vascular death, All vascular events, vascular death, and Death from any cause
timeFrame: any time
Other outcomes:
Locations:
city: Kanto Area
country: Japan
Study officials:
References:
Clinical trial NCT03211845: Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients
Official title: Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Aging
Keywords: Ehealth
Older adults
Undernutrition
Feasibility study
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: European Union
name: Consorci Sanitari de Terrassa
name: Viveris Technologies SA
name: STMicroelectronics Grenoble 2 SAS
name: Sirlan Technologies SAS
name: Habitat Health Environment
name: Universite Paris 13
name: Meditecnologia SA
name: Cybermoor Ltd
name: Telecom Sante
name: Zorggroep Noordwest-Veluwe
First posted: 2017-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this pilot study are to test the feasibility, acceptability and implementation fidelity of telemonitoring of nutritional parameters in community-dwelling older adults; to test the study procedures for effect evaluation; and to determine the likelihood of achieving desired impact on the primary and secondary outcomes.


Eligibility criteria: Inclusion Criteria:

Having a care referral for at least one of the following types of care:

* Domestic care
* Personal care
* Nursing care
* Individual or group support

Exclusion Criteria:

* Severe cognitive impairment (Mini Mental State Examination (MMSE) \< 20)
* Receiving terminal care
* Expected length of receiving home care \< three months
* Not having a television at home
* Clients with a visual impairment (not able to watch the television screen)
* Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system
* Clients with nursing home care

Primary outcomes:
measure: Feasibility (qualitative outcome)
timeFrame: 12 weeks
Secondary outcomes:
measure: Behavioural determinants
timeFrame: 12 weeks
measure: Diet quality (DHD-index)
timeFrame: 12 weeks
measure: Nutritional status (MNA)
timeFrame: 12 weeks
measure: Appetite (SNAQ)
timeFrame: 12 weeks
measure: Body weight (kg)
timeFrame: 12 weeks
measure: Physical functioning (SPPB)
timeFrame: 12 weeks
measure: Functional status (KATZ-15)
timeFrame: 12 weeks
measure: Quality of life (SF-36)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Lisette de Groot, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00195845: A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Official title: A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

Detailed description: The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Eligibility criteria: Inclusion Criteria:

* Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS \< 16; MADRS \< 16

Exclusion Criteria:

* Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia

Primary outcomes:
measure: Cognitive Function
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Robert T Dunn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229045: Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Official title: Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Caner
Keywords: gastric caner
Albumin Bound Paclitaxel
5-FU/CF
taxanes naive
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
* Male or female.
* Age 18 -75.
* Previous one line of non-taxane chemotherapy for advanced/metastatic disease.
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
* ECOG Performance status 0, 1 or 2
* Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min.
* Signed informed consent.

Exclusion Criteria:

* No prior chemotherapy for gastric cancer.
* Received any investigational drug treatment within 30 days of start of study treatment.
* Patients with active gastrointestinal bleeding.
* Neurological toxicity ≥ grade 2 NCI-CTCAE.
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
* History or clinical evidence of brain metastases.
* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
* Pregnancy women.
* Subjects with reproductive potential not willing to use an effective method of contraception.
* Patients with known active infection with HIV.
* Known hypersensitivity to any of the study drugs

Primary outcomes:
measure: PFS(Progression-free survival )
timeFrame: 80% PFS events,, an expected average of 10 months
Secondary outcomes:
measure: OS (Overall survival )
timeFrame: OS follow-up period: 18 months or 80% OS events, whichever occurs first
Other outcomes:
measure: ORR (Overall tumor response)
timeFrame: 80% PFS events, an expected average of 10 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03649945: Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
Official title: An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer


Eligibility criteria: Inclusion Criteria:

* IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
* R0 resection has been performed at least before 4 weeks.
* ECOG PS score: 0-1 points.
* Estimated survival time: at least 12 weeks.
* No radiotherapy, chemotherapy or molecular targeted therapy before.
* Main organs are functional, which meet the following criteria:

Blood Routine:

HB≥90 g/L（No blood transfusion within 14 days）, ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination： ALB≥30g / L（No blood transfusion within 14 days）, ALT\<2ULN； AST\<2ULN TBIL≤1.5ULN； Plasma Cr≤1.5ULN；

* Volunteer with signed informed consent form, good compliance and good follow-up cooperation.
* Patients who the investigator believws they can benefit.

Exclusion Criteria:

* Those who have had other malignant tumors in the past or at the same time.
* Pregnant or lactating women.
* Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) \<50%.
* Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
* Have a history of mental illness or psychotropic substance abuse.
* Patients who have participated in other drug clinical trials within 4 weeks.
* According to the investigator's judgment, patients who are at a risk or have accompanying disease.
* Patients who believe that they are unsuitable for inclusion.

Primary outcomes:
measure: 3 year disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01374945: Clearpath Miniprep Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonoscopy
Lead sponsor: EasyGlide
Sponsor class: INDUSTRY
First posted: 2011-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: Use of Clearpath to facilitate successful completion of colonoscopy procedures with sub-optimal preparation.


Eligibility criteria: Inclusion Criteria:

1. Patient 18-70 years
2. Scheduled for colonoscopy
3. Providing informed consent

Exclusion Criteria:

1. Known large polyps (\> 2 cm) for polypectomy
2. Inflammatory Bowel Disease (IBD)
3. Previous colonic surgery
4. Known or suspected stricture
5. Significant co morbidity
6. Significant diverticular disease
7. Contraindicated to receive oral Sodium Picosulfate solution

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03516045: A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
Official title: A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: 18F-AlF-NOTA-neurotensin
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 65
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: The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography (PET/CT) in patients with prostate cancer (PCa).

Detailed description: 18F-AlF-NOTA-neurotensin is a radioligand targeting the neurotensinreceptor, which is widely expressed on the cell surface of PCa. The radioligand can be used for the diagnosis and stage of the PCa. A total of 5 volunteers and 60 PCa patients will be subjected to a 18F-AlF-NOTA-neurotensin PET/CT scan. The uptake of 18F-AlF-NOTA-neurotensin in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Eligibility criteria: Inclusion Criteria:

1. Histologically and/or clinically confirmed and/or suspicious of PCa.
2. Signed informed consent.

Exclusion Criteria:

Claustrophobia (unable to accept PET/CT scanning)

Primary outcomes:
measure: 18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer
timeFrame: 12 months
Secondary outcomes:
measure: 18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of PET Center,Xiangya Hospital,Central South University
state: China, Hunan
Study officials:
affiliation: Department of PET Center,Xiangya Hospital,Central South University
name: Yongxiang Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maschauer S, Einsiedel J, Hubner H, Gmeiner P, Prante O. (18)F- and (68)Ga-Labeled Neurotensin Peptides for PET Imaging of Neurotensin Receptor 1. J Med Chem. 2016 Jul 14;59(13):6480-92. doi: 10.1021/acs.jmedchem.6b00675. Epub 2016 Jun 30.
citation: Wu Z, Li L, Liu S, Yakushijin F, Yakushijin K, Horne D, Conti PS, Li Z, Kandeel F, Shively JE. Facile Preparation of a Thiol-Reactive (18)F-Labeling Agent and Synthesis of (18)F-DEG-VS-NT for PET Imaging of a Neurotensin Receptor-Positive Tumor. J Nucl Med. 2014 Jul;55(7):1178-84. doi: 10.2967/jnumed.114.137489. Epub 2014 May 22.
citation: Deng H, Wang H, Wang M, Li Z, Wu Z. Synthesis and Evaluation of 64Cu-DOTA-NT-Cy5.5 as a Dual-Modality PET/Fluorescence Probe to Image Neurotensin Receptor-Positive Tumor. Mol Pharm. 2015 Aug 3;12(8):3054-61. doi: 10.1021/acs.molpharmaceut.5b00325. Epub 2015 Jul 21.
Clinical trial NCT05004545: Compare Hemodynamic Parameters of Propofol and Sevoflurane During CPB Time in Undergoing CABG to Avoid Lactate Level
Official title: To Compare Hemodynamic Parameters of Propofol and Sevoflurane During Cardiopulmonary Bypass Time in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery to Avoid Lactate Level.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamic Instability
Keywords: Propofol
Sevoflurane
hemodynamic stability
Lactate level
Lead sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
Sponsor class: OTHER_GOV
First posted: 2021-08-13
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients.

Detailed description: Objective: To compare hemodynamic parameters of propofol and sevoflurane during cardiopulmonary bypass time in patients undergoing coronary artery bypass graft (CABG) surgery to avoid lactate level.

Methods: One hundred and twenty six patients scheduled for CABG from May 2017 to May 2018 will be included in this study. Non probability consecutive sampling will be used. Patients will be divided in two groups, propofol will be given to group 1, and sevoflurane will be given to group 2. Age, clamp time, bypass time, mean arterial blood pressure on bypass machine and lactate level will be compared between two groups. SPSS version 24 will used and p value ≤ 0.05 will be considered as significant.

Eligibility criteria: Inclusion Criteria:

CABG

Exclusion Criteria:

Emergency surgery

Primary outcomes:
measure: Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Cardiac Surgery ICU
state: Punjab
Study officials:
affiliation: Chaudhry Pervaiz Elahi Institute of Cardiology
name: Kaneez Ume Farwa, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944645: MK0524A Bioequivalence Study (0524A-059)
Official title: An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is willing to follow all study guidelines

Exclusion Criteria:

* Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
timeFrame: Predose and up to 24 hours postdose
measure: Total Amount of Urinary Excretion of Niacin and Its Metabolites
timeFrame: Predose and up to 96 hours postdose
measure: Area Under Curve (AUC 0-infinity) of Laropiprant
timeFrame: Predose and up to 48 hours postdose
measure: Maximum Concentration (Cmax) of Laropiprant
timeFrame: Predose and up to 48 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: