louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01917526: The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
Official title: The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: Oxygen
PACU
Hypoxemia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 500
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: PREVENTION

Brief summary: After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.

This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.

Detailed description: The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.

Eligibility criteria: Inclusion Criteria:

* General anesthesia
* Age 18-70 years
* American Society of Anesthesiology (ASA)physical status 1-3
* Elective case

Exclusion Criteria:

* ASA physical status class 4 or more
* Unstable pulmonary diseases
* BMI \> 35 kg/m2
* oxygen saturation \< 94% when breathing in room air
* Respiratory muscle weakness eg.myasthenia gravis
* Central nervous system abnormalities eg.drowsiness, hypoventilation
* Patients who have been intubated or needed ventilatory support before operation
* Plan to remain intubated after the operation
* Intracranial, intrathoracic and upper abdomen surgery
* Patients who nasogastric tube is inserted
* Airway problems eg. sinusitis
* Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery
* Patient refusal

Primary outcomes:
measure: Number of Participants With Hypoxemia in Both Groups
timeFrame: In PACU (1 hr after anesthesia)
Secondary outcomes:
measure: The Causes of Hypoxemia
timeFrame: In PACU (1 hr after anesthesia)
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Manee Raksakietisak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608226: Impact of Health Lifestyle on Body Weight
Official title: Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body-Weight Trajectory
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who completed a pharmacotherapy trial will be recruited and who consent to this follow-up study.

Brief summary: Pharmacotherapy becomes an important and effective approach to improve body weight. However, it still remains unclear how to manage potential fluctuation after its cessation. Lifestyle change is the foundation and included as a part of clinical routine in real-world, therefore, we plan to conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from treatment. In addition, body weight related results will be described.

Detailed description: Novel pharmacotherapy is emerging, leading to substantial and sustained improvement in body weight compared with placebo in clinical trials. However, there is no evidence on management of body weight in real world setting after cessation of treatment. Body weight fluctuation is a pivotal difficulty for obese subjects who left off pharmacotherapy. It would be interesting to investigate the impact of real-world health lifestyle and its compliance in this clinical situation and probe into factors affecting compliance. Therefore, we will conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from pharmacotherapy cessation. In addition, body weight related results will be described.

Eligibility criteria: Inclusion Criteria:

* All patients who completed a pharmacotherapy trial
* Those who consent to this FU study

Exclusion Criteria:

* Those who do not consent to this study

Primary outcomes:
measure: Fluctuation in body weight
timeFrame: 6 months
Secondary outcomes:
measure: Change of blood lipids
timeFrame: 6 months
measure: Change of blood glucose levels
timeFrame: 6 months
measure: Change of blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaoying Li
Study officials:
References:
Clinical trial NCT05397626: Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
Official title: Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Fatigue Syndrome
Keywords: Heart Rhythm Biofeedback; Hydrogen Water
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Natural Wellness Now Health Products
First posted: 2022-05-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study involves three active intervention groups: group 1 receiving heart rhythm biofeedback alone, group receiving hydrogen water alone, and group 3 receiving both heart rhythm biofeedback and hydrogen water.
Primary purpose: TREATMENT

Brief summary: The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Detailed description: The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.

Eligibility criteria: Inclusion Criteria:

Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI\>30.

Exclusion Criteria:

* Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Short Form-36 Physical Function Subscale
timeFrame: 8 weeks
measure: Depression, Anxiety and Stress Scale
timeFrame: 8 weeks
measure: Brief Resilience Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Fred Friedberg
state: New York
Study officials:
affiliation: Stony Brook University
name: FRED FRIEDBERG, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781426: PrEP Among MSM and TG in Myanmar
Official title: Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Pre-exposure prophylaxis of HIV infection
PrEP
MSM
TG
Lead sponsor: Myanmar Oxford Clinical Research Unit
Sponsor class: OTHER
Collaborators: name: Medical Action Myanmar
name: Institute of Tropical Medicine, Belgium
First posted: 2021-03-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals self-identified as belonging to the MSM and/or TG population who are eligible in line with selection criteria

Brief summary: HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.


Eligibility criteria: Inclusion Criteria:

* HIV-negative
* No suspicion of acute HIV infection
* Substantial risk of HIV infection
* Creatinine clearance is more than 30 ml/min
* Willingness to use PrEP as prescribed, including periodic HIV testing
* Willingness to sign informed consent

Exclusion Criteria:

• Anyone who is not eligible with the inclusion criteria

Primary outcomes:
measure: Uptake rate of PrEP
timeFrame: through study completion, an average of 1 year
measure: HIV seroconversion rate among PrEP user
timeFrame: through study completion, an average of 1 year
measure: STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Medical Action Myanmar Clinics
Study officials:
affiliation: Medical Action Myanmar
name: NiNi Tun, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01626326: San Francisco Stop Smoking App - Pilot Study
Official title: Evaluation of a Stop Smoking iPhone App
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recruitment
Keywords: smoking
smoking cessation
mobile app
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 9935
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: Adults who use iPhone stop smoking apps

Brief summary: This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported smoking status. The investigators secondary measure will be obtained quit rates and number of cigarettes smoked before and after using the app.

To enter the study, participants must download the app from iTunes at:

https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8

Detailed description: The investigators research team has developed smoking cessation self-help tools administered as printed brochures and Internet stop smoking sites. These self-help tools have demonstrated quit rates similar to those obtained with the nicotine patch. The investigators now want to see if mobile device apps might also help people quit.

This is the investigators first pilot study with a research version of the investigators stop smoking app for the iPhone. The investigators want to get estimates of how many people will download the app per month, how many will actually use the app, and how many will provide follow-up information on whether they quit, and if not, how many cigarettes they are smoking now. The investigators will use this information to plan a randomized controlled trial to determine efficacy of the app for stopping smoking.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Must download the iPhone app from iTunes at: https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8

Exclusion Criteria:

* less than 18 years of age

Primary outcomes:
measure: Recruitment rates
timeFrame: Three years
Secondary outcomes:
measure: Utilization
timeFrame: One year
measure: Follow-up completion rates
timeFrame: One year
measure: Quit rates
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psychiatry at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ricardo F Muñoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.
Clinical trial NCT00297726: A Study to Examine the Efficacy of the Arthritis Self Management Program
Official title: A Prospective Study to Examine the Efficacy of the Arthritis Self Management Program (ASMP) in Patients With Osteoarthritis (OA) in Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis, Ankle
Arthritis
Self-Management
Lead sponsor: Alberta Bone and Joint Health Institute
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program.

Detailed description: This study will provide an analysis of the efficacy of the Arthritis Self Management Program (ASMP) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at Alberta Health and Wellness. This study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (BMI) and stage of disease.

Eligibility criteria: Inclusion Criteria:

* OA of the hip and/or knee
* Patient is 18 years of age and over

Exclusion Criteria:

* a concurrent systemic inflammatory disease
* Patient has previously participated in an arthritis self management educational program
* Patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years
* Patient has been diagnosed with senile dementia or Alzheimer's disease

Primary outcomes:
measure: A difference in the WOMAC score of 20 percentage points
Secondary outcomes:
measure: A change in health care provider and medication utilization.
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Cyril B Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05118126: Gut Microbiota in ITP
Official title: Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ITP
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
First posted: 2021-11-11
Enrollment: 240
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: Patients with newly diagnosed ITP who would receive first-line therapy (glucocorticoid therapy with platelet infusion) according to the clinician's or patient's decision.

Brief summary: Prospective, observational study to explore the significance of gut microbiome in the diagnosis of ITP, and to identify the predictive value of baseline gut microbiome for GC resistance/relapse.

Detailed description: A prospective, observational study to (1) collect fecal samples from ITP patients at initial diagnosis (baseline) and after first-line GC treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of ITP, and (5) identify the predictive value of baseline gut microbiome for GC resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of ITP.

Eligibility criteria: Inclusion Criteria:

* 18 years or older;
* Isolated thrombocytopenia (platelet count of less than 100×10\^9/L);
* Normal leukocyte and erythrocyte counts according to routine blood tests;
* Did not receive any medication for thrombocytopenia for 6 months.

Exclusion Criteria:

* Secondary ITP such as drug-associated thrombocytopenia;
* Thrombocytopenia caused by viral infection (HIV, Hepatitis B virus or Hepatitis C virus);
* Nursing or pregnant women;
* Severe dysfunction of the heart, kidney, lung or liver;
* Active or previous malignancy;
* Patients with other diseases were undergoing treatment with immunosuppressants;
* Myelodysplastic disorder or myelofibrosis;
* Patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months.

Primary outcomes:
measure: AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
timeFrame: 1 month
Secondary outcomes:
measure: AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
timeFrame: 3 months
measure: AUC value of 6-month drug resistance/relapse using baseline gut microbiota
timeFrame: 6 months
measure: Time to response
timeFrame: 6 months
measure: Duration of response
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Peking University Insititute of Hematology
name: Xiao-Hui Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931526: Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)
Official title: Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infection
Critically Ill
Keywords: Tigecycline
Continuous Renal Replacement Therapy
Pharmacokinetics
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives

Brief summary: The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.

The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years,hospitalized ICU patients, male or female;
* having definitive diagnosis to treat with tigecycline for bacterial infection;
* receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.

Exclusion Criteria:

* Patients with Child-Pugh C cirrhosis;
* Allergic to tetracycline or tigecycline;
* Patients received CRRT for \< 3 days or treated with tigecycline \< 3 days;
* Patients who are pregnant.

Primary outcomes:
measure: Tigecycline Steady State Plasma Concentrations
timeFrame: Day 1-3
Secondary outcomes:
measure: Peak Plasma Concentration(Cmax) of Tigecycline in blood
timeFrame: Day 1-3
measure: Trough Plasma Concentration(Cmin) of Tigecycline in blood
timeFrame: Day 1-3
measure: Area Under the Plasma Concentration versus Time Curve(AUC)
timeFrame: Day 1-3
measure: Minimal Inhibitory Concentration(MIC)
timeFrame: Day 1-3
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital,Southern Medical Unversity
name: Wang Liqing, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669.