louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03936374: A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
Official title: A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.


Eligibility criteria: Inclusion Criteria:

* Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (\>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2)
* Body mass index (BMI) of 18.0 kilogram per meter square (kg/m\^2) to 32.0 kg/m\^2
* Women participants must have documented proof that they are not of childbearing potential

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
* Concomitant use of strong inhibitors or strong inducers of CYP3A4
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of BMS-986205
timeFrame: Up to Day 29
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205
timeFrame: Up to Day 29
measure: Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
timeFrame: Up to Day 29
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
timeFrame: Up to Day 36
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 29
measure: Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 29
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 29
measure: Number of Participants with Clinical Laboratory Results Abnormalities
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Antonia Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03205774: Positioning and Ultrasound Examination of the Gastric Antrum
Official title: Effect of Positioning on Ultrasound Examination of the Gastric Antrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Ultrasound
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.


Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2 volunteers

Exclusion Criteria:

* Diabetes mellitus
* previous gastrointestinal surgery
* Medication affecting gastric motility
* digestive diseases, gastroparesis
* Pregnancy

Primary outcomes:
measure: Change in ultrasound measurement of the antral cross sectional area according to the position
timeFrame: through study completion, an average of 20 min
measure: Change in qualitative ultrasound assessment of gastric contents according to the position
timeFrame: through study completion, an average of 20 min
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT04637074: A Cohort Study on Thrombectomy for Stroke
Official title: Registrated Cohort Study on Thrombectomy for Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing brain infarction complicating the large-vessel occlusion

Brief summary: The cerebral collateral circulation refers to the subsidiary network of vascular channels that stabilize cerebral blood flow when principal conduits fail. Collateral status differs among patients with acute ischemic stroke. Relatively sparse attention has been devoted to the role of baseline collateral circulation in patients with acute ischemic stroke who are candidates for revascularization. This study aim to investigate the correlation between baseline collateral circulation and the likelihood of opening of an arterial occlusion, the extent of reperfusion, tissue injury and clinical impairment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Mechanical thrombectomy initiated within 24 hours after onset
* CT perfusion can be performed before the initiation of thrombectomy and 24h after thrombectomy

Exclusion Criteria:

* Contraindication to imaging with contrast agents
* Delay between imaging and beginning of thrombectomy \> 90 minutes

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology, First Affiliated Hospital of Fujian Medical University
Study officials:
References:
Clinical trial NCT06641674: EGFR Mutation Targeting Molecular Probe for PET Imaging
Official title: Development and Clinical Translation of EGFR Mutation Targeting PET Probe
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: PET imaging
EGFR mutation
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer patients or lung cancer patients treated with TKIs

Brief summary: In this project, investigators plan to develop a F-18 labeled molecular probe in order to detect the EGFR mutation tumor lessions in patients to identify patients benefiting fromTKIs treatment, and evaluate its efficacy in detecting EGFR Del 19 mutant lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or 1.
2. Patients could understand and sign the informed consent form voluntarily with good compliance.
3. Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
4. Women had to be using an effective contraceptive method (effective contraceptive means sterilisation, intrauterine hormonal devices, condoms, contraceptives/pills, sexual abstinence, or partner's removal of the vas deferens) during the study and for 6 months after the study. Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period.
5. Predicted survival greater than 3 months;

Exclusion Criteria:

1. Severe hepatic or renal dysfunction;
2. Pregnant or nursing;
3. Known allergy to the investigational drug or its excipients in study;
4. Unable to comply with the PET/CT imaging procedures;
5. Claustrophobia or other psychiatric disorders;
6. Other conditions deemed unsuitable for participation in the trial;

Primary outcomes:
measure: Standard Uptake Value Value
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05502874: Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Official title: Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracerebral Hemorrhage
Neurologic Deficits
Hemorrhagic Stroke
Hemorrhage
Keywords: Intracerebral Hemorrhage
Neurological Deterioration
Neuroimaging
Prognosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

Brief summary: This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome.

Detailed description: Neurological deterioration affects approximately one-third of patients with primary intracerebral hemorrhage (ICH) and increases the risk of death and dependency. However, the risk factors of early neurological deterioration (END), such as biochemical parameters, neuroimaging, and systemic complications, are not well documented in primary ICH, and the effective predictors of END is unknown.

This multicenter observational study aims to seek out the risk factors of END in patients with primary ICH and to investigate the association between END and outcome.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of primary intracerebral hemorrhage

Exclusion Criteria:

* Patients with secondary
* Undergo surgical evacuation of hematoma；
* Presenting contraindications or refusal to MRI
* Is pregnant
* Patients refuse to be followed up for any reasons.

Primary outcomes:
measure: Early neurological deterioration (END)
timeFrame: 48 hours after admission
Secondary outcomes:
measure: Late neurological deterioration (LND)
timeFrame: 7 days
measure: Functional outcome
timeFrame: 90 days, 1 year, 2 years after admission
measure: Hematoma expansion
timeFrame: 24 hours after admission
measure: The quality of life
timeFrame: 90 days, 1 year, 2 years after admission
measure: Depression status
timeFrame: 90 days, 1 year, 2 years after admission
measure: Cognitive function
timeFrame: 90 days, 1 year, 2 years after admission
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00002174: Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
Official title: Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Adjuvants, Immunologic
Thalidomide
Cytokines
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.

Detailed description: Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* CD4+ cell count \>= 200/microliter or \> 14% CD4+ cells in peripheral blood.
* Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

* Fertile females.
* Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer.

Patients with any of the following prior conditions are excluded:

HIV related pre-existing peripheral neuropathy.

Prior Medication:

Excluded:

Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide.

Required:

10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
Study officials:
References:
Clinical trial NCT00934674: Study Comparing Two Different Tablet Formulations Of Bosutinib
Official title: A Single Dose Bioequivalence Study Comparing the Commercial Tablet Formulation to the Clinical Tablet of Bosutinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is comparing 2 formulations of bosutinib in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of non-childbearing potential, age 18 to 50 years.

Exclusion Criteria:

* Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01015274: Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Official title: Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cachexia
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 10
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample of healthy males

Brief summary: The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.


Eligibility criteria: Inclusion Criteria:

* Male
* 30-75 years old
* Body Mass Index (BMI) \<27 kg/m2

Exclusion Criteria:

* Uncontrolled hypertension
* Glomerular filtration rate less than 60 mL/min/1.73 m2
* History of recurrent gastrointestinal bleeding
* Unable or unwilling to provide informed consent
* Ongoing anti-coagulant therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: BIOCHEMANALYSIS CORPORATION
name: Morteza Janghorbani, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Melinda Sheffield-Moore, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02328274: A Modified Technique for Laparoscopic Subtotal Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subtotal Hysterectomy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 19
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis

Brief summary: Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. The standard surgical procedure in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus, dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel, monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative time and higher possibility of conversion to laparotomy due to technical difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a modified surgical technique of LASH which incorporated two methods of vessels ligation and laparoscopic in situ morcellation.


Eligibility criteria: Inclusion Criteria:

* patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
* complete medical record

Exclusion Criteria:

* patients aged below 20 years old
* uterine malignancy
* incomplete medical record

Primary outcomes:
measure: Operation time
timeFrame: at time of surgery
measure: Intraoperative blood loss
timeFrame: at time of surgery
Secondary outcomes:
measure: Post-operative complications
timeFrame: up to 7 days post operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01293474: Choroidal Thickness in Glaucoma Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma Patients and Healthy Controls
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients and controls are selected out of our primary care clinic

Brief summary: With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal thickness in glaucoma patients and healthy controls is proposed.

* Trial with medical device


Eligibility criteria: Inclusion criteria: for both groups (glaucoma study group and control group):

men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: for both groups (glaucoma study group and control group):

* less then 50 years of age
* any pathology of the central retina
* any optic nerve disorder other then glaucoma
* retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma

Primary outcomes:
measure: COV
timeFrame: t0
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
state: ZH
Study officials:
affiliation: University Hospital Zurich, Ophtalmic Clinic
name: Christoph Kniestedt, Ass. Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02936674: Color-dependent Melatonin Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melatonin
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2016-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.


Eligibility criteria: Inclusion Criteria:

* Stable health
* Normal color vision
* Normal hearing
* 18-35 years old

Exclusion Criteria:

* Significant depressive symptoms
* Pregnant or nursing
* Ocular pathologies
* Unstable or severe medical or psychiatric condition
* Extreme morning/evening type
* Regular smoker
* Use of medications that impact ocular function
* Alcohol use disorder
* Use of illegal drugs
* Irregular use of antihistamines, antidepressants, or sleeping medications

Primary outcomes:
measure: Melatonin suppression
timeFrame: 4 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: