louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02699008: High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay
Official title: High On-treatment Platelet Reactivity to Adenosine Diphosphate Identified by Multiple Platelet Function Assay Guide to Modify Anti-platelet Strategy in Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: clopidogrel；antiplatelet therapy
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss the "true HPR" or over estimate HPR, which may lead to randomized trials failed. It is not known whether combined multiple platelet function testing could assist to ensure"ture"HPR and improve clinical outcomes.

Detailed description: This was a single-center, randomized, prospective study. ACS patients undergoing PCI treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: MPAADP by Light transmittance aggregometry（LTA）, MAADP by Thrombelastography (TEG) ,and CTP2Y by Innovance PFA-200 . According to three result（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR(n=125) or unHPR(n=232), HPR patients were divided into HPR-Ticagrelor(HPR-T)and HPR-Clopidogrel(HPR-C) randomized. HPR-T group(n=77) patients' antiplatelet agents changed to ticagrelor, both unHPR and HPR-C groups keep unchanged(Clopidogrel). The major adverse cardiovascular events (MACE) were recorded during 1 year Follow-up.

Eligibility criteria: Inclusion Criteria:

* ACS patients（UAP;USTEMI,STEMI）
* Undergoing PCI
* Oral antiplatelet therapy

Exclusion Criteria:

* Stable CAD

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 1 year
Secondary outcomes:
measure: Bleeding events
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhou xin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06336408: The SLEEP-CARE Study
Official title: Explore the Effects of SLEEP Deprivation on Short-term Outcomes in ICU pAtients basEd on polysomnogRaphy：a Single-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disturbance
Keywords: Polysomnography
intensive care unit
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored.


Eligibility criteria: Inclusion Criteria:

* adults (≥ 18-years old)
* anticipated SICU stay for 24 hours or more

Exclusion Criteria:

* pregnancy
* Have a clear history of medication for sleep disorders
* History of mental or psychological illness
* Treated with CRRT or ECMO during monitoring

Primary outcomes:
measure: Compound outcome index
timeFrame: Discharge from ICU or 2 weeks
Secondary outcomes:
measure: LOS
timeFrame: Through study completion, an average of 10 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT01443208: Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
Official title: A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: pharmacokinetics
safety
desvenlafaxine
Korean healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Elevated risk of suicide, in the opinion of the investigator or expert consultant
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: For single dose: maximum concentration (Cmax)
timeFrame: day 1
measure: For single dose: time to first occurence of Cmax (Tmax)
timeFrame: day 1
measure: For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
timeFrame: day 1
measure: For multiple dose: maximum concentration (Cmax)
timeFrame: day 8
measure: For multiple dose: time to first occurence of Cmax (Tmax)
timeFrame: day 8
measure: For multiple dose: trough concentration (Ctrough)
timeFrame: day 8
measure: For multiple dose: area under curve (0-24hours) (AUC0-24)
timeFrame: day 8
Secondary outcomes:
measure: For single dose if data permit: terminal elimination half life (t1/2)
timeFrame: day 1
measure: For single dose if data permit: area under curve (0-infinity) (AUCinf)
timeFrame: day 1
measure: For single dose if data permit: oral clearance (CL/F)
timeFrame: day 1
measure: For single dose if data permit: apparent volume of distribution (Vz/F)
timeFrame: day 1
measure: For multiple dose if data permit: accumulation factor (Rac)
timeFrame: day 8
measure: For multiple dose if data permit: terminal elimination half life (t1/2)
timeFrame: day 8
measure: For multiple dose if data permit: oral clearance (CL/F)
timeFrame: day 8
measure: For multiple dose if data permit: apparent volume of distribution (Vz/F)
timeFrame: day 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04417608: Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block
Official title: Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 66
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 who are scheduled for upper limb surgery

Brief summary: For patients who undergoing hemodialysis, it is important to have good AV fistula. One third of AV fistula usually fail during early stage. It is helpful to use nerve block to dilate the blood vessels and enhance the prognosis. But 0.2% Ropivacaine usually cause muscle weakness in present studies. The investigators hope to find the lowest concentration to provide sympathectomy without muscle weakness. Because the patients with hemodialysis usually have multiple co-morbidity, thus we choose patients with forearm fracture at the first place. With this result, the investigators can design further study for patients with hemodialysis. The investigators prefer proximal approach because brachial plexus run together in the cosctoclavicular space and show lower incidence of incomplete work.


Eligibility criteria: Inclusion Criteria:

* Age between 20-80 y/o, BW: 40-90 kilograms，ASA class I-III，No pre-existing neuropathy，Scheduled for upper limb surgery.

Exclusion Criteria:

1. Pre-existing neuropathy (ex: polyneuropathy)
2. History of allergy to xylocaine、ropivacaine、epinephrine
3. Emergent surgery
4. Coagulopathy
5. Patient who can not express themselves

Primary outcomes:
measure: Change of diameter of basilic vein and brachial artery
timeFrame: Change from baseline diameter(pre-nerve block) at 45min
measure: Change of diameter of basilic vein and brachial artery
timeFrame: Change from baseline diameter(pre-nerve block) at 24hour
measure: Change of diameter of basilic vein and brachial artery
timeFrame: Change from baseline diameter(pre-nerve block) at 48hour
Secondary outcomes:
measure: Sensory block of upper limb
timeFrame: 45min post nerve block
measure: Sensory block of upper limb
timeFrame: 24hour post nerve block
measure: Motor block of upper limb
timeFrame: 45min post nerve block
measure: Motor block of upper limb
timeFrame: 24hour post nerve block
measure: Motor block of upper limb
timeFrame: 48hour post nerve block
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01097408: Pharmacokinetics of AZD7295 Capsules
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Arrow Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers, aged 18-65 years.

Exclusion Criteria:

* Previous exposure to AZD7295, clinically relevant disease.

Primary outcomes:
measure: Pharmacokinetics of AZD7295 capsules
timeFrame: 0-72h after each dose
Secondary outcomes:
measure: Safety and tolerability of AZD7295 capsules
timeFrame: 0-72h after each dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Research
Study officials:
affiliation: Quotient Clinical Research
name: Jo Collier, Mb ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120508: Functional Neuroimage in Assessment of Post-stroke Aphasia
Official title: Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Aphasia
Keywords: stroke
aphasia
rTMS
Functional MRI
Speech training
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2014-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.

Detailed description: 2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.

Eligibility criteria: Inclusion Criteria:

* Aphasic stroke in chronic stage (over 3 months)

Exclusion Criteria:

* No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Primary outcomes:
measure: Concise Chinese Aphasia Test
timeFrame: Before the rTMS intervention, at 2nd week, and 3rd month
Secondary outcomes:
measure: Functional MRI
timeFrame: Before rTMS intervention, and at the day completing the rTMS treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
name: Po-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai PY, Wang CP, Ko JS, Chung YM, Chang YW, Wang JX. The persistent and broadly modulating effect of inhibitory rTMS in nonfluent aphasic patients: a sham-controlled, double-blind study. Neurorehabil Neural Repair. 2014 Oct;28(8):779-87. doi: 10.1177/1545968314522710. Epub 2014 Feb 13.
citation: Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
Clinical trial NCT07024108: Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
Official title: Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients under general anaesthesia scheduled for major abdominal surgeries between the period from January 2025 to june 2025 will be observed for comparison between PI and PPV in detecting intravascular volume.

Brief summary: Each year, at least 310 million patients undergo major surgery worldwide, procedures that involve the administration of intravenous fluids Intraoperative hemodynamic management is challenging because precise assessment of the adequacy of the intravascular volume is difficult during surgery Achieving optimal IV fluid therapy should improve perioperative outcomes and is a key component in many perioperative guidelines and pathways. IV fluids, like other medications, should only be given in well-defined protocols according to individual needs More recently, so called dynamic predictors of fluid responsiveness such as pulse pressure variation (PPV), stroke volume variation (SVV), or Perfusion Index (PI) have been used in intraoperative goal directed fluid therapy ( GDT) hemodynamic protocols


Eligibility criteria: Inclusion Criteria:

-

Inclusion Criteria:

ASA 1, 2 Age: 18-65 Undergoing major abdominal surgeries Mechanically ventilated and sedated patients

Exclusion Criteria:

Chronic cardiac arrhythmias High doses of vasopressors Altered myocardial function (left ventricular ejection fraction \< 50%) Peripheral vascular disease Severe respiratory disease Pulmonary or intra-abdominal hypertension Open chest

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison between perfusion index and pulse pressure variability for prediction of intravascular volume during major abdominal surgeries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Faculty of medicine AinShamsU
name: Randa Ali Shokry
role: STUDY_CHAIR
References:
Clinical trial NCT05569408: eVusheld Assessment reaL wORld Effectiveness in DoD Health System
Official title: An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
Keywords: Evusheld
tixagevimab and cilgavimab
Pre-exposure prophylaxis
COVID-19
SARS-CoV-2
Effectiveness
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 4724
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All EUA-eligible patient population in the Department of Defence health system.

Brief summary: An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system.

Detailed description: This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the DoD health system.

Eligibility criteria: Inclusion Criteria:

1. Receipt of Evusheld under the FDA EUA for Evusheld
2. Eligibility for Evusheld use under the EUA. -

Exclusion Criteria:

* None

Primary outcomes:
measure: COVID-19 Hospitalisation
timeFrame: up to 6 months
measure: All-cause mortality
timeFrame: up to 6 months
Secondary outcomes:
measure: Documented SARS-CoV-2 infection
timeFrame: Up to 6 and 12 months
measure: Medically attended COVID-19
timeFrame: Up to 6 and 12 months
measure: COVID-19 hospitalisation
timeFrame: Up 12 months
measure: COVID-19 Intensive Care Unit (ICU) admisssion
timeFrame: Up 6 and 12 months
measure: COVID-19 related mortality
timeFrame: Up to 6 and 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Research Site
state: Maryland
Study officials:
References:
Clinical trial NCT02345408: Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma
Official title: An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 54
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: This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.

Detailed description: Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
* Anticipated life expectancy ≥ 12 weeks
* Radiographically measurable disease acc. to RECIST 1.1
* Use of adequate contraception (as described in protocol)
* Ability to provide written informed consent and comply with study requirements

Exclusion Criteria:

* Received other cancer treatment or investigational drug within 4 weeks prior to screening
* Women who are pregnant or breastfeeding
* Had major surgery within 4 weeks of first dose of study drug
* Inadequate liver, renal or bone marrow function within 2 weeks of first dose
* Serious concurrent illness, altered medical status or any uncontrolled medical condition
* Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
* Known active HIV, HBV or HCV infection
* Inability to swallow tablets
* History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation

Primary outcomes:
measure: progression-free survival
timeFrame: 24 weeks
measure: subject incidence of Grade 3 or 4 adverse events
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
facility: Netherland
city: Sittard
country: Netherlands
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: