louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04597320: Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients
Official title: The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine
Fentanyl
Sedation Complication
Keywords: Esketamine
Fentanyl
sedation
Pediatric dental patients
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fentanyl group and Esketamine group
Primary purpose: PREVENTION

Brief summary: Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The purpose of this study was to investigate and compare the efficacy of esketamine sedation and fentanyl sedation in pediatric dental patients


Eligibility criteria: Inclusion Criteria:

* Age 6-14 years old.

  * Oral out-patient sedative treatment in our hospital.

    * BMI between 18 to 30 kg/m2. ④. ASA: I-II degree. ⑤. Sign the informed consent.

Exclusion Criteria:

* Patients who are allergic to esketamine, opioids, propofol, or have contraindications for these drug use.

  * Patients with mental illness or who are unable to cooperate.

    * Patients who have abnormal reaction to midazolam. ④. Patients who suffer from Apnea. ⑤. Patients who refuse to sign informed consent. ⑥. Patients who participated in other clinical trials within 4 weeks.

Primary outcomes:
measure: Hypoxemia
timeFrame: Day 0
measure: Midazolam use
timeFrame: Day 0
Secondary outcomes:
measure: Successful sedation
timeFrame: Day 0
measure: Respiratory depression
timeFrame: Day 0
measure: Agitation and delirium
timeFrame: Day 0
measure: Circulatory fluctuation
timeFrame: Day 0
measure: Propofol requiring
timeFrame: Day 0
measure: Time of successful sedation
timeFrame: Day 0
measure: MOAA/S score in recovery room
timeFrame: Day 0
measure: The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4
timeFrame: Day 0
measure: Directional force recovery time
timeFrame: Day 0
measure: Recall of intraoperative events
timeFrame: Day 0
measure: Treatment comfort score
timeFrame: Day 0
measure: The incidence of complications
timeFrame: Day 1
measure: Visual Analogue Scale(VAS) of pain in recovery room
timeFrame: Day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
Study officials:
affiliation: Department of anesthesiology of peking university school of stomatology
name: Xudong Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01392820: A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japan
Elderly
PK
SAD
MAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy elderly male and female ≥65 years old.
* Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
* Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion Criteria:

* History of any clinically significant medical or neurologic disease or disorder.
* History of gastrointestinal surgery or unintentional rapid weight loss.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.

Primary outcomes:
measure: assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS.
timeFrame: During the whole study period, ca. 50 days
Secondary outcomes:
measure: characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers.
timeFrame: PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Hans Eriksson, MD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Shunji Matsuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.
Clinical trial NCT04463420: Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
Official title: Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 224
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 study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment


Eligibility criteria: Inclusion Criteria:

* Conscious consent to participate in the study
* Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.
* Strong clinical suspicion of covid 19 with positive findings in CT Scan
* Shortness of breath

Exclusion Criteria:

* Patients with HIV
* Patients with cancer undergoing chemotherapy
* Patients receiving Immune Mediators
* Patients need hospitalization in the intensive care unit
* Patients with uncontrolled heart, kidney or liver failure
* Pregnant or lactating women
* Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)

Primary outcomes:
measure: Dyspnea
timeFrame: up to 14 days
Secondary outcomes:
measure: long of hospitalization
timeFrame: up to 28 days
measure: Radiological Treatment Response
timeFrame: up to 14 days
measure: Mortality
timeFrame: Up to 28 days
measure: Allergic drug
timeFrame: up to 14 days
measure: Laboratory Treatment Response
timeFrame: up to 14 days
measure: O2 saturation without supplemental oxygen
timeFrame: up to 14 days
measure: drug reactions Adverse
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References:
Clinical trial NCT05391360: Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Study in Healthy Subjects and Chronic Hepatitis B Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Freethiadine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B, Chronic
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 128
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: OTHER

Brief summary: The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B


Eligibility criteria: Inclusion Criteria:

Health volunteer:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 45 years of age inclusive.
3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
4. Physical examination and vital signs without clinically significant abnormalities.

Patients with chronic hepatitis B:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 65 years of age inclusive.
3. Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
4. No cirrhosis.

Exclusion Criteria:

Health volunteer:

1. Use of \>5 cigarettes per day during the past 3 months.
2. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
3. Donation or loss of blood over 450 mL within 3 months prior to screening.

Patients with chronic hepatitis B:

1. AFP\>50 ng/mL.
2. INR\>1.5.
3. Positive for Viral hepatitis C, HIV and syphilis.

Primary outcomes:
measure: Adverse Events
timeFrame: From Days 1-35
measure: AUC
timeFrame: Day 1-12
measure: HBV DNA
timeFrame: Day 1-35
Secondary outcomes:
measure: HBsAg
timeFrame: Day 1-35
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Hospital of Southern Medical University
state: Guangdong
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Southern Hospital of Southern Medical University
name: JinLin Hou, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: JunQI Niu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061160: Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient
Official title: Acute Effects of Continuous Verses Interval Aerobic Training on Autonomic Dysreflexia in Spinal Cord Injury Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Continuous Aerobic Exercise
Interval Aerobic Exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the Acute effects of continuous verses interval aerobic training on autonomic dysreflexia in Spinal Cord injury Patient. To Determine the Acute effects of these training on, Exercise Self efficacy and pain.


Eligibility criteria: Inclusion Criteria:

* Spinal cord injury Patients with level of injury below T 10
* Acute Spinal Cord Injury (Usually Acute phase lasts 8-12 weeks)
* Patients Had experience of Syncope or Postural Hypotension

Exclusion Criteria:

* Neurological disease,
* Cognitive impairment (Mini-Mental State Examination \< 22) ,
* Acute and chronic infections

Primary outcomes:
measure: Baroreflex sensitivity (BRS)
timeFrame: 4th Week
measure: Heart rate reserve (HRR)
timeFrame: 4th Week
measure: Systolic and diastolic blood pressure
timeFrame: 4th week
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 4th Week
measure: Pain perception
timeFrame: 4th week
measure: Exercise self-efficacy
timeFrame: 4th week
measure: QOL Index-Spinal cord injury version questionnaire
timeFrame: 4th Week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Rehabilitation Sciences
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02394860: Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension
Official title: Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Periodontitis
Hypertension
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be included men with severe and moderate periodontitis

Brief summary: The aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.


Eligibility criteria: Inclusion Criteria:

* -Men- \>40 years
* moderate and severe generalized chronic periodontitis
* Former diagnosis of hypertension
* \>12 teeth

Exclusion Criteria:

* \>70 years
* smokers (\>10 cig/day)
* body mass index\>30
* Need of antibioprophylaxis
* Medical treatment including anti-inflammatory drugs and/or antibiotics
* Refractory form of hypertension- aggressive periodontitis

Primary outcomes:
measure: Measuring the thickness of the intima-media
timeFrame: 15 days
Secondary outcomes:
measure: Evaluation of anatomical changes that may occur at the arterial level
timeFrame: Within 15 days after inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de parodontologie
Study officials:
affiliation: CHRU Strasbourg
name: Olivier HUCK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00309660: Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Keywords: PPARgamma ligand
Rosiglitazone
Enema
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2006-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine models of colitis. The aim of this study was to evaluate the effect of treatment with local PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and after treatment by endoscopical and clinical activity score.


Eligibility criteria: Inclusion Criteria:

* Distal ulcerative colitis (Mayo Clinical Score \> 7)
* Age \> 18 years
* Written consent

Exclusion Criteria:

* Age \< 18 years
* Severe ulcerative colitis
* Systemic treatment with steroids or azathioprin within the last 3 month
* Known liver or kidney disease
* Severe heart failure
* Pregnancy or breast feeding

Primary outcomes:
measure: Clinical response
Secondary outcomes:
measure: Endoscopic response
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. Gastroenterology C, Herlev University Hospital
Study officials:
affiliation: Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark
name: Jørn Brynskov, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219660: Obstructive Sleep Apnea (OSA) Anesthesia and Positive Airway Pressure
Official title: Obstructive Sleep Apnea (OSA) Anesthesia and Positive Airway Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: sleep
apnea
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can successfully use APAP following general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients with Obstructive Sleep Apna

Exclusion Criteria:

* non conformers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03636360: The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Official title: The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Circadian Dysregulation
Mood
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Seoul Semiconductor
First posted: 2018-08-17
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.


Eligibility criteria: Inclusion Criteria:

* Good self-reported health
* Normal color vision

Exclusion Criteria:

* No sleep disorders
* No extreme chronotype
* Regular smoker
* Significant hearing loss
* Depression
* Alcohol use disorder
* Use of illegal drugs
* Pregnant

Primary outcomes:
measure: Alertness
timeFrame: 15 hours
measure: Melatonin suppression
timeFrame: 3 hours
Secondary outcomes:
measure: Mood
timeFrame: 15 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT01413360: The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Official title: Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis
Chronic Hepatitis C
Chronic Alcoholic Hepatitis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

Detailed description: The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Chronic hepatitis C patients

   * positive anti-HCV antibody more than 6 months
   * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
   * not indicated for antiviral therapy with interferon and ribavirin
2. Chronic alcoholic hepatitis

   * significant alcohol drinking history and no other cause of chronic hepatitis
   * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

Exclusion Criteria:

* Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
* decompensated liver cirrhosis
* platelet \< 50,000/uL or white blood cell \< 1,500/uL
* need and willing for antiviral therapy
* significant renal dysfunction (GFR \< 30 mL/min/kg) or history of renal stone
* hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
* pregnancy, lactating woman

Primary outcomes:
measure: The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D, Ph.D
role: STUDY_DIRECTOR
References: