louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03921775: A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
Official title: A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia for Elective Surgery Patients
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.


Eligibility criteria: Inclution Criteria:

1. 18\~60 years, female or male
2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)
3. BMI: 18\~30 kg/m2
4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria:

1. Patients scheduled for emergency surgery
2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
4. Pregnant women or those in lactation period
5. Allergic to drugs used in the study
6. Patients with respiratory management difficulties (Modified Mallampati grade IV)
7. Patients have participated in other clinical trial within the 3 months prior to randomization
8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Primary outcomes:
measure: Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
timeFrame: Average of 2 hours
Secondary outcomes:
measure: Time from start of investigational medicinal product administration to loss of consciousness
timeFrame: Average of 2 hours
measure: Time from stop of investigational medicinal product to MOAA/S Score=5
timeFrame: Average of 2 hours
measure: Time from stop of investigational medicinal product to Aldrete Score>9
timeFrame: Average of 2 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04595175: Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)
Official title: Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: Serology
Wellness
SARS-CoV-2 IgG
Seroprevalence
Healthcare Workers
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Chandler Regional Medical Center
name: Arizona General Hospital
name: Mercy Gilbert Medical Center
First posted: 2020-10-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be enrolled across CommonSpirit Health hospitals and care facilities (all branded as Dignity Health) at five sites in Maricopa County, Arizona: Arizona General Hospital, Chandler Regional Medical Center, Mercy Gilbert Medical Center, St. Joseph's Hospital and Medical Center and St. Joseph's Westgate Medical Center.

Brief summary: The Investigators propose a multi-center, observational, longitudinal, cohort study of the serology and wellness of HCWs over a year of the COVID-19 pandemic.

Detailed description: All consenting participants will undergo survey assessment and diagnostic testing with the Abbott Architect SARS-CoV-2 IgG assay (IgG) every three months for a one year period. Clinical outcomes and related data capture will be performed at this same interval.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years; and
2. Be an active member of the CommonSpirit Health workforce or medical staff during the COVID-19 pandemic and at the time of enrollment; and
3. Have access to the Internet; and
4. The ability to provide informed consent.

Exclusion Criteria:

1. Subjects that lack the ability for longitudinal follow-up; and/or
2. Subjects that do not meet the above inclusion criteria. -

Primary outcomes:
measure: Baseline IgG Assay Information
timeFrame: Baseline
measure: Change in IgG Assay Information
timeFrame: From Baseline to 3 months, 6 months, 9 months, & 12 months
measure: Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups
timeFrame: From Baseline to 3 months, 6 months, 9 months, & 12 months
measure: Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
Study officials:
affiliation: Chief Medical Officer Dignity Health Arizona
name: Brian Tiffany, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927575: Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
Official title: Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrist Injury
Tibial Fracture
Hip Injury
Keywords: TOMOSYNTHESIS
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

Detailed description: Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.

Eligibility criteria: Inclusion Criteria:

* Physician request to have diagnostic imaging for condition areas

Exclusion Criteria:

* Under 18
* Pregnancy
* Insufficient Anatomical Coverage or Potential Image Problems

Primary outcomes:
measure: Number of Participants for Whom Tibia Injury Was Detected
timeFrame: Baseline Imaging Collection
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Davide Bova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02369575: Identification of Novel Markers of Human Lung Disease
Official title: Identification of Novel Markers of Human Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients on lung transplant waiting list

Brief summary: The purpose of this study is to investigate new therapies for advanced lung disease.

Detailed description: This research study is being conducted to learn about the progression and cause of lung disease. By agreeing to be a part of this study, you will allow the lung tissue which would normally have been discarded after your procedure, to be used for research purposes to allow us to understand more about your condition which may potentially lead to novel treatments and therapeutics. For this study, the investigators will isolate specific cells from the lung tissue and measure cellular, molecular and genetic mechanisms responsible for regulating lung disease. No other type of research will be performed on these samples nor will the samples be given to other investigators for unrelated research.

Eligibility criteria: Inclusion Criteria:

* any one on lung transplant list

Exclusion Criteria:

* HIV positive

Primary outcomes:
measure: The development of novel therapeutics for interstial lung disease
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
Study officials:
affiliation: Ohio State University
name: Megan Ballinger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030275: A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Official title: A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertrophic Scar
Keywords: Hypertrophic scar
Cicatrix
Scar prevention
Scar revision
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.


Eligibility criteria: Inclusion Criteria:

* Adults, 21-55 years of age in general good health
* Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length
* Scar to be revised must have been present for \> 9 months

Exclusion Criteria:

* Use of tobacco or nicotine-containing products
* Pregnant or lactating
* Post-menopausal or full hysterectomy

Primary outcomes:
measure: Reduction in recurrence of hypertrophic scarring after scar revision surgery
timeFrame: 9 months
Secondary outcomes:
measure: Safety of RXI-109
timeFrame: 9 months
Other outcomes:
Locations:
city: Lake Worth
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: St. Louis
country: United States
state: Missouri
city: Huntersville
country: United States
state: North Carolina
city: San Pedro Sula
country: Honduras
Study officials:
affiliation: RXi Pharmaceuticals
name: Pamela Pavco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06663475: A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence
Official title: The Effectiveness of a Transtheoretical Model Based Health Education Intervention in Smoking Cessation Among Expectant Fathers: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Behavioral Intervention
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 1346
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.


Eligibility criteria: Inclusion Criteria:

* male adult
* has a pregnant partner
* at least smoke 1 cigarette per day on average in the last month
* be able to read or communicate in Chinese

Exclusion Criteria:

* be or was participated in other smoking cessation program in the past year
* mentally or physically unable to communicate with
* can't play videos by electronic devices
* the pregnant partner is a smoker

Primary outcomes:
measure: Biochemically validated smoking abstinence
timeFrame: 12 month follow-up after randomization
Secondary outcomes:
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 6, 12-month follow-up
measure: Smoking Reduction
timeFrame: end of intervention; 3,6,12 month after randomization
measure: Quit Attempt
timeFrame: end of intervention; 3,6,12 month after randomization
measure: The change in transtheoretical model stages
timeFrame: end of intervention; 3,6,12 month after randomization
measure: the Fagerstrom tolerance questionnaire
timeFrame: end of intervention; 3,6,12 month after randomization
measure: Use of smoking cessation services
timeFrame: end of intervention; 3,6,12 month after randomization
measure: Biochemically validated smoking abstinence
timeFrame: 6 month follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03291275: Survival Outcomes of Uterine Malignancies in Chinese Population
Official title: Survival Outcomes of Uterine Malignancies in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with definite diagnosis of uterine malignancies in China.

Brief summary: This study aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study.


Eligibility criteria: Inclusion Criteria:

* Primary uterine malignancies.

Exclusion Criteria:

* Metastatic malignancies to uterine corpus

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Ma SQ, Tan XJ, Zhong S, Wu M. Pelvic Exenteration for Recurrent and Persistent Cervical Cancer. Chin Med J (Engl). 2018 Jul 5;131(13):1541-1548. doi: 10.4103/0366-6999.235111.
Clinical trial NCT00584675: Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers
Official title: Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
laryngopharyngeal reflux disease
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish normal values for the Dx-pH Measurement System.

Detailed description: The specific aim of this study is to establish the normal range of values in an adult population with no symptoms of laryngopharyngeal reflux disease or gastroesophageal reflux disease using the Dx-pH Measurement System.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* no symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease
* score less than 10 on Reflux Symptom Index

Exclusion Criteria:

* age less than 18
* known lidocaine allergy
* history of heartburn, regurgitation, chronic cough, voice changes, globus pharyngeus, excessive throat clearing, or swallowing problems
* score 10 or greater on Reflux Symptom Index
* current or past antacid use or other antireflux therapy
* history of antireflux surgery
* pregnancy
* current anticoagulation therapy (warfarin, heparin, aspirin, clopidogrel bisulfate)
* special/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)

Primary outcomes:
measure: To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux.
timeFrame: At completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter Belafsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037375: Physical Activity, Body Composition, and Prevalent Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate the relationship of childhood lifestyle and physical characteristics to prevalent asthma.

Detailed description: BACKGROUND:

Morbidity and mortality from pediatric asthma have been increasing in developed countries over the past three decades, making asthma the most common chronic disease of children. A joint session at the American Thoracic Society meeting in May 2000 was titled "Childhood Asthma: Is Change in Lifestyle the Key"? During this session, the hypothesis was advanced that a lack of physical exercise and higher levels of childhood obesity may be contributing to an increased incidence of asthma among United States children.

DESIGN NARRATIVE:

Data from physician diagnosed pediatric asthma were assessed for relationships with the potential risk factors body mass index, percent fat and lean tissue, obesity, and physical activity. The data pertained to a large population-based multi-ethnic cohort of school children (n=826) from the Detroit area for whom, using dual-energy x-ray absorptiometry, precise measurements of whole body bone mass, and soft tissue composition were collected along with height and weight measurements in 1992-1993, when the children were nine years old. Detailed data on physical activity, collected with consultation with an exercise physiologist, and prevalent asthma diagnosis and symptoms, collected under the direction of a respiratory disease/pediatric epidemiologist and a pediatric allergist, were obtained at the same time.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Edward Peterson
References:
citation: Johnson CC, Ownby DR, Zoratti EM, Alford SH, Williams LK, Joseph CL. Environmental epidemiology of pediatric asthma and allergy. Epidemiol Rev. 2002;24(2):154-75. doi: 10.1093/epirev/mxf013. No abstract available.
citation: Alford SH, Zoratti E, Peterson EL, Maliarik M, Ownby DR, Johnson CC. Parental history of atopic disease: disease pattern and risk of pediatric atopy in offspring. J Allergy Clin Immunol. 2004 Nov;114(5):1046-50. doi: 10.1016/j.jaci.2004.08.036.
Clinical trial NCT00858975: Study of Cryotherapy for Renal Tumors
Official title: Study of Cryotherapy for Renal Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Tumors
Keywords: renal tumor
cryotherapy
cytokine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the change of tumor size and serum cytokine in the patients who received cryotherapy for the renal tumors.


Eligibility criteria: Inclusion Criteria:

* The patients who have renal tumor less than 7 cm and receive cryotherapy

Exclusion Criteria:

* The tumor size is larger than 7 cm
* The patients do not approve the surgery

Primary outcomes:
measure: Tumor size
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: