louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01506908: Provoked Craving Assessment
Official title: Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Dependence
Smoking
Keywords: craving
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers


Eligibility criteria: Inclusion Criteria:

* Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

Exclusion Criteria:

* Any disease that may interfere with the absorption, metabolism or excretion of the study product.
* A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia

Primary outcomes:
measure: Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
timeFrame: Post-cue baseline,5 minutes
Secondary outcomes:
measure: Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
timeFrame: Post-cue baseline, 1 minute post treatment administration
measure: Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
timeFrame: Post-cue Baseline, 3 minutes post treatment administration
measure: Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
timeFrame: Post-Cue Baseline, 7 minutes post treatment administration
measure: Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
timeFrame: Post-Cue Baseline, 10 minutes post treatment administration
measure: Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
timeFrame: Baseline to Day 5 post treatment administration
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Los Angeles Clinical Trials
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.
Clinical trial NCT02189408: Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration
Official title: Effect of Platelet Rich Plasma ( PRP ) Applied During Knee Arthroscopy on Pain, Function and Quality of Life - A RCT With a Follow up of 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Cartilage Damage
Meniscal Tear
Keywords: Platelet rich plasma
Autologous conditioned plasma
Outerbridge
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized- controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.


Eligibility criteria: inclusion Criteria:

* degenerative knee pain
* age: \> 18 years
* informed consent
* none to moderate comorbidity
* arthroscopy under general anaesthesia indicated

exclusion Criteria:

* trauma of the knee within the last 6 weeks before surgery
* circumscribed cartilage lesion with possibility of repair microfracture or autologous chondrocyte transplantation - procedures
* contraindications against PRP. application
* malignancies
* severe comorbidities
* age \<18 years
* physically or mentally not able to provide informed consent
* severe knee instability
* corticosteroid injections within the last 6 weeks before surgery

Primary outcomes:
measure: pain ( VAS )
timeFrame: 6 months
Secondary outcomes:
measure: pain ( VAS )
timeFrame: 6 weeks, 12 months
measure: knee function (Lysholm-score )
timeFrame: 6 weeks, 6 months, 12 months
measure: quality of life ( physical und mental summaries of SF-36 German version )
timeFrame: 6 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Orthopaedics at the St. Josef- Hospital
Study officials:
affiliation: Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
name: Christoph von Schulze Pellengahr, MD
role: STUDY_DIRECTOR
References:
citation: Duif C, Vogel T, Topcuoglu F, Spyrou G, von Schulze Pellengahr C, Lahner M. Does intraoperative application of leukocyte-poor platelet-rich plasma during arthroscopy for knee degeneration affect postoperative pain, function and quality of life? A 12-month randomized controlled double-blind trial. Arch Orthop Trauma Surg. 2015 Jul;135(7):971-7. doi: 10.1007/s00402-015-2227-5. Epub 2015 May 10.
Clinical trial NCT01278108: First-in-Human Single Ascending and Multiple Dose of GLPG0778
Official title: Double-blind, Placebo-controlled, Dose-ranging Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* healthy male
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* any condition that might interfere with the procedures or tests in the study
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single and multiple dosing
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of single and repeated doses, including effect of food.
timeFrame: up to 10 days postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01655108: Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
Official title: BLIND RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MESOTHERAPY MINOXIDIL HAIR WITH 0.5% / 2ML VERSUS PLACEBO IN THE TREATMENT OF FEMALE ANDROGENETIC ALOPECIA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Female Pattern Alopecia
Keywords: Androgenetic Alopecia
Mesotherapy
Minoxidil
Trichogram
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.

* Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks.
* One group will receive 0.5%/2ml minoxidil application and a control group will receive application of placebo (saline 0.9%).
* Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before and 08 weeks after treatment as a method objective evaluation of the response

Detailed description: This is a trial that aims to analyze the efficacy and safety of mesotherapy with minoxidil 0,5% versus placebo for androgenetic alopecia in female patients.

The patients and the investigators who analyzes complementary exams are blind.

* Clinical criteria, photo, 4mm biopsia, trichogram and trichoscopy are perfomed before patients are randomized into two arms :

  1. Group 1 (Placebo):

     30 patients who will have intradermal injections in the scalp of saline 0.9%
  2. Group 2 (Active Drug):

     30 patients who will receive intradermal injections in the scalp with minoxidil 0.5%/2ml

     Eight weeks after the last session patients will be recruited for repeat the exams and perform a self-assessment of both the effect on hair growth and the effect on hair loss.

Eligibility criteria: Inclusion Criteria:

* Women from 18 to 65 years old
* Androgenetic Alopecia (female pattern hair loss)

Exclusion Criteria:

* patients with alopecia areata or cicatricial alopecia
* pregnancy and breastfeeding
* have undergone any specific treatment in the last 06 months
* use of drugs with anti-androgenic properties
* patients with signs or symptoms of hyper-androgynism

Primary outcomes:
measure: Increase in hair density
timeFrame: Sixteen weeks
Secondary outcomes:
measure: Mesotherapy safety
timeFrame: six months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Barbara Uzel, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brasilia
name: Izelda Costa, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04832308: Mobile Intervention Supervised Exercise Therapy Study 1
Official title: Mobile Intervention Supervised Exercise Therapy Study 1
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Artery Disease
Claudication, Intermittent
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Society for Vascular Surgery
First posted: 2021-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization stratified by site.
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.

Detailed description: This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and "usual care" for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life.

Eligibility criteria: Inclusion Criteria:

* 18 years of Age
* Rutherford Class I-II PAD (claudication)
* Ambulatory
* Exercise Therapy Naive (\>18 mo)
* Primary Owner of an Android or iOS device
* Willingness to participate (text, call, fill out surveys) via a mobile phone

Exclusion Criteria:

* Symptomatic coronary artery disease
* Oxygen dependent COPD
* Significant osteoarthritis limiting ambulation

Primary outcomes:
measure: Number of Participants Who Complete a 12-week Exercise Therapy Program
timeFrame: 12 weeks.
Secondary outcomes:
measure: Mobile Phone Delivered 6-Minute Walk Test
timeFrame: Weeks 0, 6 and 12
measure: Passive Activity as Measured on Mobile Device
timeFrame: 12 weeks.
measure: Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)
timeFrame: Weeks 1, 6, and 12
measure: Adherence as Measured by Completion of Scheduled Daily Walks
timeFrame: 12 weeks.
measure: Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year
timeFrame: 1 year.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01103908: Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass
Official title: Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Output
Keywords: cardiac output
cardiopulmonary bypass
ultrasound dilution
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-04-15
Enrollment: 3
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.

Brief summary: Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (age \< 21 years)
* Pediatric patients undergoing surgery involving cardiopulmonary bypass

Exclusion Criteria:

* Patients aged \> 21 years
* Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)

Primary outcomes:
measure: Cardiac output after cardiopulmonary bypass
timeFrame: Less than 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Transonic Systems Inc.
name: Nikolai Krivitski, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Alistair Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269708: Improving Cardiac Secondary Prevention
Official title: Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Secondary Prevention
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 200
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: The purpose of this study is to determine whether providing individuals with personalized information on cellular aging, including telomere length, will stimulate them to adhere to cardiac prevention strategies and improve exercise capacity.

Detailed description: Individuals who have sustained a heart attack are at considerable risk for future cardiac events. A cardiac rehabilitation and exercise program can reduce this risk but it remains a challenge to adopt optimum lifestyle changes. We will determine whether providing individuals with information on leukocyte telomere length, will motivate them to improve their exercise performance. We will test whether professionally conveying this information will stimulate an individual to adhere to proven cardiac prevention strategies, looking at the extent to which one's exercise capacity improves over time.

Eligibility criteria: Inclusion Criteria:

1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program

Exclusion Criteria:

1. Individuals with genetic mutations that affect telomere length
2. Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers

Primary outcomes:
measure: Exercise capacity based on cardiopulmonary exercise testing
timeFrame: after 6-month cardiac rehabilitation program
Secondary outcomes:
measure: Adherence to supervised exercise sessions
timeFrame: 6 months
measure: Activity assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, Western University
state: Ontario
Study officials:
affiliation: Western Faculty
name: J. Geoffrey Pickering, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997308: A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1446
to investigate safety and tolerability in Healthy subjects during 4 weeks of administration
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 97
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85
* Body mass index (BMI) between 18 and 30 kg/m2
* Clinically normal findings on physical examination

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.

Primary outcomes:
measure: To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
timeFrame: During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).
Secondary outcomes:
measure: To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff.
timeFrame: PK sampling taken at defined timepoints during the treatment period (study days 1-28)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research
Study officials:
affiliation: AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden
name: Bo Fransson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden
name: Björn Paulsson, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01343108: The Impact of Nurses' Emotional Labor on Job Satisfaction and Burnout
Official title: The Impact of Nurses' Emotional Labor on Job Satisfaction and Burnout
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction
Keywords: Emotional Labor
Burnout
Job Satisfaction
Emotional Intelligence
Job stress
Job involvement
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 157
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nurses

Brief summary: Emotional labor is one of the bases that organizations earn profits. Nursing care needs high emotional labor to offer health care to patients. Among health carers that emphasize a lot on emotional labor, nurses are especially required to include emotional labor as very important parts of their jobs.

Detailed description: This study intends to investigate the association among emotional labor, job satisfaction, and burnout. Furthermore, the moderating effect of job stress , job involvement and emotional intelligence will be studied. The study population includes all nurses (N=18,446) of Taiwan's medical centers. Of which, 20% of randomly selected six medical centers will be delivered a questionnaire in order to further analyze the association of study variables.

The level of emotional labor, burnout, job satisfaction, job stress, job involvement and emotional intelligence of the study samples collected from questionnaires will be analyzed by using descriptive statistics, variance analyses, and SEM techniques in order to understand more the associations among study variables. Results of this study are expected to work as references to improve job satisfaction and decrease the level of burnout of nurses.

Eligibility criteria: Inclusion Criteria:

* licensed nurses in the hospitals

Exclusion Criteria:

* part-time nurses
* nurses who work under a year in the hospitals

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien
country: Taiwan
facility: Tzu Chi University
Study officials:
affiliation: Tzu Chi University
name: Cheng-I Chu
role: PRINCIPAL_INVESTIGATOR
References: