louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05868538: Calprotectin and Ischemia Modified Albumin Serum to Measure Disease Activity in Behçet's Disease
Official title: Evaluation of Calprotectin and Ischemia Modified Albumin Serum Levels as Biomarkers to Measure Disease Activity in Behçet's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behçet's Diseasecases
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty BD cases diagnosed by the International Study Group classification criteria for BD were included. BD cases were recruited from the outpatient clinic of Rheumatology and Rehabilitation Department, Mansoura University Hospitals. The study also included 60 age- and gender-matched normal subjects served as controls.

Brief summary: Behçet's Disease activity was evaluated using BD Current Activity Form (BDCAF). Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.


Eligibility criteria: Inclusion Criteria:

* new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement

Exclusion Criteria:

* concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth

Primary outcomes:
measure: BD activity was evaluated using BD Current Activity Form (BDCAF).
timeFrame: 3 years
measure: Serum calprotectin concentrations
timeFrame: 3 years
measure: Ischaemia Modified Albumin (IMA) serum concentrations
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Professor of Rheumatology and Rehabilitation
name: Sherin Mashaly, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06515938: Study on New Strategies for Hepatitis B Virus Immunization
Official title: Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Reaction
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 1169
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

Detailed description: By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Eligibility criteria: Inclusion Criteria:

* aged 25-55 years
* negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination

Exclusion Criteria:

* a history of vaccine component allergies
* autoimmune diseases
* immunodeficiency
* vaccinations received within the past month
* acute illnesses within the past week
* fever (axillary temperature exceeding 38°C) within the past three days

Primary outcomes:
measure: Anti-HBs
timeFrame: at the second month after the final injection of each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Huaibei
country: China
facility: Huaibei District Center for Disease Control and Prevention
state: Anhui
city: Xuanhua
country: China
facility: Xuanhua District Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Beijing Center for Disease Control and Prevention
name: Wei Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069938: Brain Computer Interface Control of a Robotic Device
Official title: Brain Computer Interface Control of a Robotic Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Subjects
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects, primarily from individuals on the University of Minnesota Campus and Minneapolis area

Brief summary: Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual and physical objects through the voluntary modulation of brain rhythms. Current issues with noninvasive BCIs include exhausting motor imagery tasks and long training times required to achieve competent control. The investigators will address these issues within this protocol, examining new approaches to reduce the effort required by subjects to control a physical object in the task.

The PI's hypothesis is: Control of a physical robotic device will increase the performance of subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a physical output.

Detailed description: Subjects will be recruited to participate in controlling a physical robotic device such as a quadcopter or a robotic arm using imagination of movement or other activities as detected by brain waves that can be used to control a robotic device.

The subjects will be able to observe the controlling of a robotics device using one's thought and participate in multiple sessions to learn the skills to better control such a device.

Eligibility criteria: Inclusion Criteria:

* Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old).

Exclusion Criteria:

* History of neurological deficit or traumatic brain injury.

Primary outcomes:
measure: Percent of trials correct within each session of Brain Computer Interface experiments.
timeFrame: Session 1 through 10, within an average of 5 weeks. Each session separated by at least 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Nils Hasselmo Hall at the University of Minnesota - Twin Cities Campus
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bin He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997838: Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled Trial to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Vivozon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-25
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.


Eligibility criteria: Inclusion Criteria:

* Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential.
* Planning to undergo abdominoplasty
* Ability to provide written informed consent
* Ability to understand study procedures and communicate clearly with the investigator and staff
* American Society of Anesthesiologists (ASA) risk class of I to II.

Exclusion Criteria:

* Emergency or unplanned surgery
* Previous abdominoplasty
* Pre-existing condition causing preoperative pain around the site of surgery
* Women who are pregnant or breastfeeding
* Chronic pain diagnosis and ongoing or frequent use of pain medications

Primary outcomes:
measure: Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
timeFrame: 0-12 hours post-emergence
Secondary outcomes:
measure: Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence
timeFrame: 0-24 hours post-emergence
measure: Total number of requests for rescue medication for 24 hours post-emergence
timeFrame: 0-24 hours post-emergence
measure: Total amount of rescue medication consumption for 12 hours post-emergence
timeFrame: 0-12 hours post-emergence
measure: Total amount of intra-operative fentanyl use
timeFrame: During surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Vivozon, Inc.
name: Doo Lee, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03993938: Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Official title: Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Keywords: transcatheter mitral valve repair
pleth variability index
Mitraclip
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk. Successful MitraClip application depends on intraprocedural quantification of mitral regurgitation and left atrial pressure (LAP) monitoring. The pleth variability index (PVI) is a noninvasive, dynamic index based on analysis of the respiratory variations in the plethysmographic waveform recorded transcutaneously by the pulse oximeter. Studies demonstrate that PVI is accurate in predicting fluid responsiveness in mechanically ventilated adult patients. In this study, we wish to measure PVI during TMVR and correlate with invasive indices such as left atrial pressure (LAP) and stroke volume variation. Our study hopes to provide a real-time non-invasive alternative to invasive indices to better guide fluid management and improve hemodynamics.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with mitral regurgitation undergoing transcatheter mitral valve repair(TMVR) with Mitra-Clip(R) at Henry Ford Hospital - Main Campus.

Exclusion Criteria:

* MitraClip(R) procedure unsuccessful (defined as no clip deployment and/or procedural interruption due to complication), concomitant aortic regurgitation or stenosis of moderate or greater degree existed, patients with grade II or above diastolic dysfunction on echocardiography, previous mitral valve intervention (either surgical or percutaneous), patients requiring continuous vasopressor infusions during the procedure, or patients in whom PVI monitoring was not performed due to technical issues, patients with atrial fibrillation, or preprocedure moderate or greater mitral stenosis

Primary outcomes:
measure: Delta PVI to Delta LAP Correlation During MitraClip Placement
timeFrame: Intraprocedure
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT00450138: Open Label, Phase I ZD6474 Head and Neck Cancer Study
Official title: An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMA™ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: Squamous Cell Carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.


Eligibility criteria: Inclusion Criteria:

* Stage III-IV squamous cell carcinoma of the head and neck

Exclusion Criteria:

* No previous treatment for head and neck cancer, adequate cardiac function

Primary outcomes:
measure: To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer
timeFrame: assessed at each visit
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT00357838: Pulse Waves and Tongue Diagnosis Differences Between Follicular and Luteal Phase in Normal Healthy Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: normal healthy women
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2006-07-28
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: We hypothesized that there's difference between follicular phase and luteal phase of normal women in radial pulse waves and tongue figures.

Detailed description: As comparing with follicular and menstrual phases of the cycle, in women during the luteal phase, the heart rate, body temperature, foot skin temperature and body weight were significantly increased. Tongue inspection and pulse examination are two methods that Chinese medical doctors are used in the diagnosis of patterns. Pulse wave analysis of the radial artery is a non-invasive, widely applicable technique for assessing cardiovascular function. Radial artery waveforms have been demonstrated being associated with the blood pressure wave of ascending and central aorta, the function of left ventricle , the arterial wall properties and the endothelial function. Even when measure locally, carries characteristic information from the whole arterial system because of reflection of waves at distinct sites of the arterial system. Examination of the changes of the arterial pulse wave between follicular phase may offer valuable insights into cardiovascular physiologic feature in menstrual cycle. The objective of this study was to test the hypothesis that the cyclic variations in hemodynamic and volume parameters during the menstrual cycle among normal healthy women. To that end we compared the following parameter of radial pulse contour between late follicular and late luteal time point: percussion wave, the difference between dicrotic wave and dicrotic notch, and the area of the wave.

Eligibility criteria: Inclusion Criteria:

1. Nornal period I/D=28-35/3-5 (eumenorrheic)
2. age:21-40
3. No use of oral pills in past 6 months
4. BMI1: 8.5-24.9
5. No history of smoke, alcohol or drug abuse
6. No regular exercise in past 3 month

Exclusion Criteria:

1. CVD, hepatic, renal disease
2. psychological disease
3. Thyroid disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: China Medical Univerity Hospital
Study officials:
affiliation: China Medical University Hospital
name: Shan-Yu Su, MD
role: STUDY_CHAIR
References:
citation: Spaanderman ME, Van Beek E, Ekhart TH, Van Eyck J, Cheriex EC, De Leeuw PW, Peeters LL. Changes in hemodynamic parameters and volume homeostasis with the menstrual cycle among women with a history of preeclampsia. Am J Obstet Gynecol. 2000 May;182(5):1127-34. doi: 10.1067/mob.2000.105342.
Clinical trial NCT04903743: POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES
Official title: ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Patient
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.


Eligibility criteria: Inclusion Criteria:

* (ASA) II or III
* scheduled for diabetic foot surgeries.

Exclusion Criteria:

* Patients who refused the anaesthetic technique,
* whose BMI ≥ 35 kg/ m2,
* unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
* patients with coagulopathy, skin infection at the site of injection,
* preoperative use of opioid or non-steroidal anti-inflammatory drugs,
* allergy or contraindication to studied medication

Primary outcomes:
measure: duration of postoperative analgesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: rehab Abd Elaziz
Study officials:
References:
Clinical trial NCT02730143: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Keywords: Altitude
Nocturnal breathing pattern
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2016-04-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.

Detailed description: Respiratory polygraphies will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and respiratory polygraphies will be performed on night 1 and 6. They will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.

A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria: Inclusion Criteria:

* born, raised and currently living \<800m
* No overnight stay at altitudes \>1500 m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000 m
* Pregnancy
* Health impairment, which requires regular treatment

Primary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
Secondary outcomes:
measure: Apnea-/hypopnea index measured by respiratory polygraphy
timeFrame: first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
measure: Oxygen desaturation index measured by respiratory polygraphy
timeFrame: first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
measure: Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)
timeFrame: first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2,7; low altitude sojourn at 520 m, day 2
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References: