louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03556774: Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program
Official title: Boosting Chinese Healthcare Service Providers' Utilization of Behavioral and Pharmacotherapy Interventions for Cigarette Smoking Cessation by 'WeChat WeQuit' Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation Intervention
Smoking Abstinence
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-06-14
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this single-blind, randomized trial, undertaken in China with 8-week interventions and follow-up to 52 weeks, about 2,200 providers will be randomly allocated to the intervention or control group.

Detailed description: Previous studies have been showed that providing behavioral and pharmacotherapy interventions for cigarette smoking patients was effective but rare among Chinese healthcare service providers. In order to minimize the huge gap between the shortage and demand for smoking cessation training program and smoking cessation service, this 'WeChat WeQuit' smoking cessation training program has been designed to assess whether it will increase Chinese healthcare service providers' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation or not.

In this single-blind, randomized trial, about 2200 HSPs will be randomly selected (by randomizeR, https://CRAN.R-project.org/package=randomizeR) to 8-week intervention (behavioral and pharmacotherapy interventions for cigarette smoking patients to help them quit smoking) group or control group that only communicates without any standard smoking cessation practices related messages, and follow-up to 52 weeks. The trial will be carried out in into two phases, the first phase is the pilot study (n=200, 8-week intervention and follow-up to 16 weeks) and the second is the main study (n=2000, 8-week intervention and follow-up to 52 weeks). It is hypothesized that 'WeChat WeQuit' training program will improve Chinese HSPs' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation and increase quit rate for smoking patients.

Eligibility criteria: Inclusion Criteria:

1. Chinese-speaking healthcare service providers
2. Know how to use WeChat
3. Use WeChat on a daily basis
4. Willing to provide informed consent to participate in the study -

Exclusion Criteria:

1. Non-Chinese speakers
2. Not healthcare service providers
3. Do not use WeChat
4. Unwilling to participate in the study -

Primary outcomes:
measure: The effectiveness of 'WeChat WeQuit' training program.
timeFrame: 52 weeks
Secondary outcomes:
measure: Prevalence of smoking abstinence
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yanhui Liao
state: Zhejiang
Study officials:
References:
Clinical trial NCT05826574: A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
Official title: A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Brensocatib
INS1007
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy participants defined by no significant other conditions as in the protocol.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, or psychiatric disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).

Note: Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)
Secondary outcomes:
measure: Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to Day 31 (Part 1) and up to Day 26 (Part 2)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: USA001
state: Texas
Study officials:
References:
Clinical trial NCT00782574: Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients
Official title: A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumours
Poly(ADP ribose) polymerases
homologous deficiency
BRCA1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled


Eligibility criteria: Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Patients with measurable or non measurable disease according to RECIST

Exclusion Criteria:

* Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
* Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for \>1 week
* Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy

Primary outcomes:
measure: To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
timeFrame: Weekly visits for routine monitoring visits
Secondary outcomes:
measure: To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
timeFrame: PK samples taken at visit 2 and 3
measure: To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.
timeFrame: Assessed at screening, visit 9, and at end of every 2 cycles
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Barcelona
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson, BSc, MBCHB, MD
role: STUDY_DIRECTOR
affiliation: Dana-Farber Cancer Institute
name: Judy E Garber
role: PRINCIPAL_INVESTIGATOR
affiliation: Vall d'Hebron
name: J Ballmana Gelpi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642874: Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients
Official title: Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 200
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: Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

Detailed description: Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Abrams et al compared patients with cirrhosis with those with congestive heart failure and found a significantly higher prevalence of weekly or daily cramps with cirrhosis (22%) vs patients with congestive heart failure (5%). Interestingly, there was no difference in diuretic use or dosing between the 2 groups, supporting that factors other than diuretic-mediated effects explained the differences. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria:

* Elderly patients.
* Encephalopathy

Primary outcomes:
measure: number of muscle cramps
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university - faculty of medicine
state: Elgharbia
Study officials:
affiliation: liver diseases dept.- Tanta university hospital
name: Sherief M. Abd-Elsalam, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: liver diseases dept.- Tanta university hospital
name: Walaa A. Elkhalawany, Consultant
role: STUDY_DIRECTOR
References:
Clinical trial NCT03067974: Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
Official title: Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Failed Moderate Sedation During Procedure
Ketamine Adverse Reaction
Keywords: ketamine
pediatric
procedural sedation
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children who meet inclusion and exclusion criteria will be approached for participation in the study.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.


Eligibility criteria: Inclusion Criteria:

* Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
* Body weight of 20kg or less (actual, estimated, or measured)
* NPO for four hours or more
* Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.

Exclusion Criteria:

* Discretion of parents
* Discretion of provider
* Body weight greater than 20kg (actual, estimated, or measured)
* Starting Aldrete score \<9/10
* Known or suspected psychosis
* Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
* Significant elevation in blood pressure
* Known hypersensitivity to ketamine
* Non-English or Spanish speaking

Primary outcomes:
measure: Successful procedural sedation
timeFrame: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner Univsersity Medical Center Tucson
state: Arizona
Study officials:
affiliation: University of Arizona
name: Vivienne Ng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03629574: Mechanical Ventilation During Cardiopulmonary Bypass
Official title: Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Mechanical Ventilation Complication
Cardiopulmonary Bypass
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 80
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs


Eligibility criteria: Inclusion Criteria:

* congenital heart diseases
* younger than 5 years
* CPB longer than 30 minutes in hypotermia
* elective surgery
* stable clinical conditions

Exclusion Criteria:

* genetic anomalies
* mechanical ventilation before the surgery
* kidney injuries
* hepatic failure

Primary outcomes:
measure: Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
timeFrame: Baseline, and 6, 12, 24 and 48 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: AOPadova
Study officials:
References:
Clinical trial NCT00166374: To Evaluate Success of Cement Treatment of Spinal Compression Fractures
Official title: Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Detailed description: Patients with vertebral compression fracture will be diagnosed and treated with balloon kyphoplasty. Pain and functional status will be assessed at baseline, 1-, 12-, and 24-months post-operatively using VAS pain scale, Oswestry Disability Index, and SF-36.

Eligibility criteria: vertebral compression fracture

Primary outcomes:
measure: pain
measure: disability
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: H. Gordon Deen, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269774: Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
Official title: Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Sleep Apnea, Obstructive
Atrial Premature Complexes
Keywords: Atrial Fibrillation
Obstructive Sleep Apnea
Atrial Premature Complexes
Pulmonary Vein Isolation
Mueller Manoeuvre
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy. We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of atrial fibrillation are initiated by PABs. However, the origin of PABs induced by intra-thoracic pressure swings is unknown. This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
* Scheduled for circumferential pulmonary venous isolation treatment
* 18 to 75 years of age
* Signed informed consent

Exclusion Criteria:

* Treated with class III anti-arrhythmic agents (at the moment of pulmonary venous isolation)
* Treated for obstructive sleep apnea
* Previous catheter ablation in the pulmonary veins or left atrium
* Severe structural heart disease
* Mental or physical disability precluding informed consent or compliance with the protocol
* Enrolled in another study that would confound the results of this trial

Primary outcomes:
measure: Electroanatomical origin of premature atrial beats
timeFrame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Secondary outcomes:
measure: Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
timeFrame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
state: Canton of Zurich
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01006174: Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
Official title: Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption of Carotenoids From Vegetables
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.


Eligibility criteria: Inclusion Criteria:

* Age range: 18-50 years.
* Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m²
* Weight stable (\<4.5 kg change within the last 3 months),
* Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months.
* Must be pre-menopausal
* Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
* Non-smoking
* Non-diabetic
* No current or planned pregnancy
* Not using any hormone-based contraceptive, e.g., pill, patch, injection, implants, etc.
* No current use of medication affecting lipid profile
* No intestinal disorders including lipid malabsorption, lactose intolerance
* No heavy consumption of alcohol (\>2 drinks per day)
* No current use of dietary supplements that affect cholesterol, (e.g. Benocol or fiber supplements) or a willingness to discontinue their use during the study.

Exclusion Criteria:

* Menopausal
* Diabetic
* Currently pregnant
* Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
* Use of lipid altering medications

Primary outcomes:
measure: Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.
timeFrame: 66 days
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References: