louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01612702: Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Official title: The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: postoperative nausea and vomiting
postoperative pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.

Detailed description: Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary osteoarthritis, knee
* Scheduled for elective total knee arthroplasty
* Signed written informed consent

Exclusion Criteria:

* Refusing participate
* Contraindication to regional anesthesia
* Severe impairment of bowel motility
* administration of other antiemetic drug within 24hours before surgery
* systemic steroid within 24hours before surgery
* history of cardiovascular \& respiratory disease
* renal \& hepatic failure

Primary outcomes:
measure: Incidence of Nausea and Vomiting
timeFrame: within 72 hours after surgery
Secondary outcomes:
measure: Pain Level
timeFrame: 6 to 24 hours after surgery
measure: Wound Complication
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Joint Reconstruction Center, Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Joint Recontruction Center, Seoul National University Bundang hospital
name: T K Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772302: Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Official title: Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consciousness Disorders
Locked-In Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: patients Arm 2: healthy controls
Primary purpose: DIAGNOSTIC

Brief summary: The primary aims of this study are:

1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS);
2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Detailed description: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS;
2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
3. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Eligibility criteria: Inclusion Criteria:

* Age\>18
* Diagnosis of coma
* Vegetative state
* Minimally conscious state
* Confusional state
* Locked-in state

Exclusion Criteria:

• History of developmental, neurologic, or major psychiatric disorder resulting in functional disability

Primary outcomes:
measure: Behavioral Diagnosis of Level of Consciousness (LoC)
timeFrame: on the day of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Brian L. Edlow, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477502: Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Official title: Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Urinary Tract Infection
Spinal Cord Injury
Keywords: urinary tract infection
spinal cord injury
homeopathy
prevention
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2011-11-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life.

* until today, there is no effective prophylaxis for UTI for patients with spinal cord injury.
* homeopathy has been shown to be an effective treatment option in several chronic diseases
* study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone


Eligibility criteria: Inclusion Criteria:

* neurogenic bladder dysfunction treated by intermittent catheterization
* recurrent (\>3/year) symptomatic urinary tract infections

Exclusion Criteria:

* inability to speak German
* already under homeopathic treatment

Primary outcomes:
measure: number of symptomatic urinary tract infections
timeFrame: one year
Secondary outcomes:
measure: number of symptomatic urinary tract infections compared to the previous year
timeFrame: one year
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic center
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Center
name: Jürgen Pannek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pannek J, Pannek-Rademacher S, Jus MS, Wollner J, Krebs J. Usefulness of classical homeopathy for the prophylaxis of recurrent urinary tract infections in individuals with chronic neurogenic lower urinary tract dysfunction. J Spinal Cord Med. 2019 Jul;42(4):453-459. doi: 10.1080/10790268.2018.1440692. Epub 2018 Feb 27.
Clinical trial NCT06574802: Er:YAG Laser and Air Polishing Application in Periodontal Treatment
Official title: Combined Application of Er:YAG Laser and Sub-gingival Air Polishing Powder in Treatment of Periodontitis: A Split-mouth, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: generalized, stage Ⅱ or stage Ⅲ
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.

Detailed description: The study will use a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus sub-gingival air polishing treatment, while the quadrants in the control group received ERL only. Clinical periodontal examinations were evaluated at baseline, 3 months, 6 months, 1 year, and 2 years.

Eligibility criteria: Inclusion Criteria:

* 1) aged 35-65 years old, in good systemic healthy;
* 2) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;
* 3) a minimum of 20 teeth

Exclusion Criteria:

* 1) pregnancy or recent pregnancy plans;
* 2) had received periodontal treatment within the previous 6 months;
* 3) taken antibiotics within the previous 3 months;
* 4) had diabetes;
* 5) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.

Primary outcomes:
measure: Changes in PD
timeFrame: at 3 months, 6 months, 1 year, and 2 years
measure: Changes in CAL
timeFrame: at 3 months, 6 months, 1 year, and 2 years
Secondary outcomes:
measure: changes in BI
timeFrame: at 3 months, 6 months, 1 year, and 2 years
measure: PLI
timeFrame: at 3 months, 6 months, 1 year, and 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
affiliation: Research Department
name: GuangXu Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02609802: The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
Official title: The Different Analgesic Potency of Sevoflurane and Desflurane at Equi-minimum Alveolar Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Orthopedic Disorders
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 77
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.

Detailed description: Volatile anesthetics vary in their relative hypnotic potencies. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetics produced different EEG-derived indices such as bispectral index. However, there was no controlled study that demonstrates the difference of analgesic potency. The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.

Eligibility criteria: Inclusion Criteria:

* patients undergoing arthroscopic shoulder surgery
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients who have not received interscalene approach brachial plexus block (refusal or failure)
* pregnant women

Primary outcomes:
measure: Analgesic potency of volatile anesthetics
timeFrame: the first 60 min of maintaining a steady state 1 MAC of volatile agents
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoungho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106702: The Navigator Project
Official title: Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
detention
substance abuse
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Jail Health Services - HIV and Integrated Services
name: San Francisco Pretrial Diversion Project
First posted: 2014-04-08
Enrollment: 271
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: Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San Francisco jail. Two thirds of those released with HIV-focused discharge planning are reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed with mental health conditions severe enough to require medication and a similar proportion report substance use disorders at the time of detention. While some community-based services exist, there remains a critical need to improve linkages to care and adherence to care plans for HIV-infected adults as they move between community and jail. The Navigator Project is a five-year randomized study that will test the effectiveness of an intensive enhanced case management intervention to reduce sex and drug-related HIV transmission risk; increase HIV medication adherence; reduce drug dependence; and reduce reincarceration.


Eligibility criteria: Inclusion Criteria:

* Detention in the San Francisco jail system
* Confirmed HIV infection
* Lifetime history of ever having met standardized criteria for drug or alcohol addiction
* Likely release back into San Francisco without transfer to another facility
* Agreement to work with Forensic AIDS Project to plan post-release care
* Able and willing to provide informed consent
* Not scheduled for release within 36 hours

Exclusion Criteria:

* Undocumented HIV status
* Inability to speak English or Spanish
* Unable or unwilling to provide informed consent
* Not under routine level of jail security

Primary outcomes:
measure: substance use
timeFrame: 2 months, 6 months, 12 months
measure: recidivism
timeFrame: 12 months
Secondary outcomes:
measure: sexual risk behavior
timeFrame: 2 months, 6 months, 12 months
measure: adherence to HIV medications
timeFrame: 2 months, 6 months, 12 months
Other outcomes:
measure: housing
timeFrame: 2 months, 6 months, 12 months
measure: medical coverage
timeFrame: 2 months, 6 months,12 months
measure: needle use
timeFrame: 2 months, 6 months, 12 months
Locations:
city: San Francisco
country: United States
facility: Tenderloin Clinical Research Foundation
state: California
Study officials:
affiliation: University of California, San Francisco
name: Janet J Myers, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052802: Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
Official title: The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Demineralization, Tooth
Demineralization, Fissure
Non-Cavitated Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.

Detailed description: Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.

The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.

Eligibility criteria: Inclusion Criteria:

* Patients with good oral hygiene
* Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible

Exclusion Criteria:

* Medical Problems or Pregnancy
* Lack of patient's approval and compliance
* Presence of abnormal oral, medical, or mental condition
* Known allergy of resin-based materials
* Previous placements of sealants or restorations
* Bruxism or mal-occlusion

Primary outcomes:
measure: Retention
timeFrame: 18 months
Secondary outcomes:
measure: Marginal integrity
timeFrame: 18 months
measure: Caries progression
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02713802: Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
Official title: An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Cuda Anesthetics, LLC
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
* Pregnant or nursing (lactating) women.
* Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
* Family history of malignant hyperthermia.
* History of drug or alcohol abuse (or tests positive at screening) or current smoker.
* Poor venous access in either arm.
* Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Bioequivalence based on pharmacokinetic parameter: Area Under Curve
timeFrame: 0-24 hours post dose
measure: Bioequivalence based on pharmacokinetic parameter: Cmax
timeFrame: 0-24 hours post dose
Secondary outcomes:
measure: Pharmacokinetic parameter: Tmax
timeFrame: 0-24 hours post dose
measure: Incidence of adverse events and tolerability
timeFrame: 7 days post dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03443102: Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome
Official title: The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS Virus
Long-Term Survivors
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003 will be enrolled.

Brief summary: SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.


Eligibility criteria: Inclusion Criteria:

* Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003

Exclusion Criteria:

* Refusal to continue the study

Primary outcomes:
measure: All-cause disability
timeFrame: Evaluations would be finished within 90 days after enrollment.
Secondary outcomes:
measure: Cardiopulmonary function
timeFrame: Evaluations would be finished within 90 days after enrollment.
measure: Life Life quaities mental distress
timeFrame: Evaluations would be finished within 90 days after enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Baoguo Jiang, Dr
role: STUDY_CHAIR
References:
citation: Li J, Zheng Y, Zhao L, Yue Z, Pan F, Chen Y, Yu B, Chen Y, Zhao G, Zhou Y, Gao Z. Investigation of the impact of SARS-CoV infection on the immunologic status and lung function after 15 years. BMC Infect Dis. 2021 Nov 24;21(1):1183. doi: 10.1186/s12879-021-06881-3.