louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989872: Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin and Soft Tissue Infections
Methicillin-resistant Staphylococcus Aureus
Keywords: Macrolides
Antibiotics
Safety
Tolerability
Pharmacokinetics
Phase I
MRSA/SSTI
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or females \[if documentation existed that they were surgically sterilized\].
* Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor.
* The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) \<450 msec.
* Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive.
* Subject has read, understood, and signed the written informed consent form.

Exclusion Criteria:

* History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances.
* History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
* Any abnormal or screening clinical lab test results...
* Medication Related exclusions...
* Lifestyle related...

Primary outcomes:
measure: The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Unit
state: Texas
Study officials:
affiliation: PPD Phase I Unit
name: Thomas L Hunt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914872: Expanded Access Neoantigen Vaccine in Solid Tumors
Official title: Expanded Access Neoantigen Vaccine in Solid Tumors
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumor, Adult
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access use study. Safety data will be collected from participants.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of a solid tumor
* Pathology review demonstrates tumor cellularity of \>30% in quantities sufficient to complete DNA and RNA library construction
* At least 18 years of age.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
* Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies.
* History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.
* Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.
* Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
* Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
* Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
* Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
* Pregnant and/or breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: William E Gillanders, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812472: Treadmill Training With Functional Electric Stimulation After Stroke
Official title: Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months
* ability to walk independently for at least 6 meters with or without use of walking aids
* ability to follow simple verbal commands or instructions

Exclusion Criteria:

* unstable medical conditions
* history of other diseases known to interfere with participation in the study
* past history of a seizure
* history of skin allergy to electrode
* use of a cardiac pacemaker

Primary outcomes:
measure: N1 latency of somatosensory evoked potential
timeFrame: Change from baseline at 4 weeks
measure: N1P1 amplitude of somatosensory evoked potential
timeFrame: Change from baseline at 4 weeks
measure: motor threshold of motor evoked potential
timeFrame: Change from baseline at 4 weeks
measure: map size of motor evoked potential
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Change from baseline at 4 weeks
measure: Motricity Index
timeFrame: Change from baseline at 4 weeks
measure: Berg Balance Scale
timeFrame: Change from baseline at 4 weeks
measure: walking speed
timeFrame: Change from baseline at 4 weeks
measure: Modified-Emory Functional Ambulation Profile
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00888472: Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma
Official title: Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Keywords: Extracorporeal leukocytapheresis
Lead sponsor: Gunma University
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 6
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: Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.

Exclusion Criteria:

* Pregnant women.
* Patients with severe cardiovascular diseases.
* Patients with infective diseases.
* Patients with leukocytopenia or anemia.

Primary outcomes:
measure: Improvement of morning peak flow rate (PEFR) or evening PEFR
timeFrame: 4 weeks after the treatment
Secondary outcomes:
measure: An improved score of asthma control test
timeFrame: 4 weeks after the treatment
Other outcomes:
Locations:
city: Maebashi
country: Japan
facility: Department Medicine and Molecular Science, Gunma University Graduate School of Medicine
state: Gunma
Study officials:
affiliation: Assistant Professor
name: Tamotsu Ishizuka, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06046872: Impacts of a Report-back Training Program
Official title: Expanding Effective Report-back of Environmental Exposures Among New Researchers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Shift (Researcher Willingness to Report-back)
Lead sponsor: Silent Spring Institute
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Researchers participate in a hands-on training program on returning personal exposure results, and pre- and post-tests assess outcomes shifts in knowledge and perspectives on its value, and willingness to implement report-back in current or future studies.

Detailed description: The investigators study the outcomes from a program that trains researchers to implement report-back, informs perspectives on the value of report-back, increases likelihood of adoption, and promotes insights from visualization of results. The investigators evaluate the training using pre- and post-tests. The training program includes an introductory module on ethical and practical benefits and best practices for report-back. This is followed by a session where researchers gain hands-on practice in report preparation using Digital Exposure Report-Back Interface (DERBI), a digital report-back tool. Pre- and post-tests assess outcomes related to their prior concerns about report-back, knowledge about report-back, shifts in perspectives on its value, novel insights about data from Researcher- DERBI, and willingness to implement report-back in current and future studies.

Eligibility criteria: Inclusion Criteria:

* Must be affiliated with a study that collects biomonitoring or personal exposure data

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Researcher wiliness to share personal exposure results as measured by pre- and post-tests administered alongside a training program
timeFrame: 3 hours (the training is approximately three hours and pre-and post-tests are administered directly before and after)
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: Virtual and in-person across the U.S.
state: Massachusetts
Study officials:
References:
Clinical trial NCT00675272: Organ Donation and Hydrocortisone Treatment
Official title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Death
Keywords: brain death
subarachnoid hemorrhage
traumatic brain injury
brain injury
intracerebral hemorrhage
organ donation
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2008-05-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Brain death patients who are selected for organ donation very often suffer from haemodynamic instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. However,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.

Detailed description: When patients are treated in the ICU only as possible organ donators they will be assessed for eligibility for the study. Iv hydrocortisone or placebo will be administered every 6 hours. Several hormonal samples will be collected.

Eligibility criteria: Inclusion Criteria: all have to be fulfilled

* severe brain injury or subarachnoid hemorrhage which progrediates to brain death and patients are treated only as candidates for organ donation in the ICU
* no other reasons for treatment than organ donation
* informed consent from official representative

Exclusion Criteria:

* age under 18
* pregnancy
* corticoid treatment before study entry
* adrenal insufficiency
* hypophyseal insufficiency
* treatment with etomidate one week before study entry
* participating in an other study
* no informed consent

Primary outcomes:
measure: dosage and time on norepinephrine treatment
timeFrame: in ICU
Secondary outcomes:
measure: Hormone levels and number of organs donated
timeFrame: Hospital treatment
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Stepani Bendel, MD
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Esko Ruokonen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tampere UH
name: Jyrki Tenhunen, MD, PhD
role: STUDY_CHAIR
affiliation: Tampere UH
name: Anna-Maija Antman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008072: Ultra-rapid Opiate Detoxification Using Deep Sedation and Prior Oral Buprenorphine Preparation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Addiction
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All opioid addicted patients who wants to undergo rapid detoxification under general anesthesia.

Brief summary: The methods of detoxification under general anesthesia have been criticized because of limited data on safety and long-term follow-up. Premedication with buprenorphine has been advocated to improve safety. In current study we want to evaluate the importance of buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Opioid addiction

Exclusion Criteria:

* Age \< 18 Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Yaakov, Zrifin
country: Israel
facility: Anesthesiology department, Assaf-Harofeh MC
Study officials:
References:
Clinical trial NCT05110872: Cigarette and E-cigarette Flavors Manipulations in the Experimental Tobacco Marketplace
Official title: COMET Study 2: Effects of Cigarette and E-cigarette Flavor Restrictions on Cigarette Demand and Substitution in the Experimental Tobacco Marketplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Cigarette
E-cigarette
Behavioral Economics
Tobacco Control
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Cancer Institute (NCI)
First posted: 2021-11-08
Enrollment: 307
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different cigarette and e-cigarette flavors are available. In all scenarios, a range of other tobacco products will also be available.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a one-session study that participants complete remotely including consent, Experimental Tobacco Marketplace purchases, and assessments to examine the effects of cigarette and e-cigarette flavors on cigarette demand and substitution in the Experimental Tobacco Marketplace.

Detailed description: This study uses a mixed design (within-subject repeated measures and between-group). Participants will be assigned to two different groups according to their preferred cigarette flavor (tobacco/menthol). Every participant will complete behavioral tasks and make hypothetical purchases of tobacco products in an online store under four different scenarios: a) e-cigarette flavor restricted and cigarette flavor restricted, b) e-cigarette flavor unrestricted and cigarette flavor restricted, c) e-cigarette flavor restricted and cigarette flavor unrestricted, d) e-cigarette flavor unrestricted and cigarette flavor unrestricted.

Eligibility criteria: Inclusion Criteria:

* currently smoke at least 10 cigarettes per day
* have smoked at least 100 cigarettes (lifetime), and
* are 21 years of age or older.

Exclusion Criteria:

* inaccurate identification of usual brand of cigarette's as menthol or non-menthol

Primary outcomes:
measure: E-cigarette substitution
timeFrame: 1 day
measure: Cigarette demand
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Fralin Biomedical Research Institute at VTC
name: Warren K Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826072: Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery
Official title: Association Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Keywords: Single Nucleotide Polymorphism
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unrelated Chinese Han patients undergoing elective cardiac surgery with CPB

Brief summary: Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.


Eligibility criteria: Inclusion Criteria:

* Chinese Han unrelated population
* adult patients
* undergoing elective cardiac surgery with CPB

Exclusion Criteria:

* malignant tumor
* autoimmune disease, immunodeficiency or immunosuppressive therapy
* chronic renal disease (glomerular filtration rate \< 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification\>A)
* COPD, tuberculosis or other chronic pulmonary diseases
* anemia with hemoglobin lower than 90mmHg
* bleeding disorders
* postoperative pericardial tamponade requiring re-operation
* postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

Primary outcomes:
measure: Acute lung injury after cardiac surgery with cardiopulmonary bypass
timeFrame: 24h after surgery
Secondary outcomes:
measure: circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE Ⅱ score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days
timeFrame: 24h and 1 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
citation: Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. Association between inflammatory genetic polymorphism and acute lung injury after cardiac surgery with cardiopulmonary bypass. Med Sci Monit. 2010 May;16(5):CR260-5.