louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02546180: Improving Patient Understanding of the Surgical Hospital Experience: Use of YouTube Video Playlist
Official title: Improving Patient Understanding of the Surgical Hospital Experience: Use of YouTube Video Playlist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Patient education
Preoperative anxiety
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective randomized pilot clinical trial studied the effect on preoperative anxiety of watching a series of YouTube videos designed to create a virtual hospital experience for patients undergoing primary total hip and knee arthroplasty as compared to routine preoperative education.

Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be reduced by patient exposure to a virtual hospital inpatient experience delivered by a series of YouTube videos.

Detailed description: As high patient anxiety prior to surgery has been linked to more severe and persistent pain after joint replacement surgery, the Orthopedic Surgery Department at Mayo Clinic in Florida created a playlist of 16 YouTube videos aimed at creating a virtual hospital experience for primary total hip and knee joint replacement patients. A pilot study was then performed to evaluate the potential impact of viewing this playlist on preoperative anxiety.

Methods: Each patient completed a Generalized Anxiety Disorder Score (GAD) assessment at the time of the routine preoperative clinic visit and were then randomized based on their gender, type of surgery, and initial GAD score to either the control group of standard education (education at face-to-face clinical visits as well as printed educational materials) or the treatment group of standard education plus access to the YouTube playlist. On the morning of the patient's surgery the same survey was repeated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total hip or total knee arthroplasty at Mayo Clinic in Florida
* Patients must be able to give consent to the study
* Patients must agree to watch the videos prior to scheduled surgery
* Patients must agree to complete the questionnaire in the office and again prior to surgery on the day of surgery

Exclusion Criteria:

* No internet access at home
* Visual or auditory conditions which limit a patient's ability to view the You Tube videos at home

Primary outcomes:
measure: Change in Generalized Anxiety Disorder (GAD) Score
timeFrame: Baseline, approximately 2-3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Mary O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor MI, Brennan K, Kazmerchak S, Pratt J. YouTube Videos to Create a "Virtual Hospital Experience" for Hip and Knee Replacement Patients to Decrease Preoperative Anxiety: A Randomized Trial. Interact J Med Res. 2016 Apr 18;5(2):e10. doi: 10.2196/ijmr.4295.
Clinical trial NCT04461080: Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK)
Official title: Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK): a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Poverty
Keywords: poverty
income
social determinants of health
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Memorial University of Newfoundland
name: Dalhousie University
name: University of Manitoba
name: University of Saskatchewan
First posted: 2020-07-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, two-arm 1:1 individual participant allocation randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty.

Detailed description: Population: Patients seen by interprofessional primary care teams who are living on estimated annual incomes that are below the Canadian Low-Income Cut-Off (LICO)

Intervention: A Community Health Worker who implements an intervention that addresses a number of social needs, including improving income security, access to prescription medications, access to housing, reducing social isolation, paying for utilities and access to transportation

Control: Information on community resources on social needs

Outcome: Change in estimated annual income between baseline and at 6 months

Eligibility criteria: Inclusion Criteria:

* 18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs

Exclusion Criteria:

* Has worked with a similar CHW or intervention in the past 1 year.

Primary outcomes:
measure: change in estimated annual income
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Andrew D Pinto, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177280: Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: retrospective chronic low back pain
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic low back pain patients

Brief summary: This study explored the prevalence of DDEs in a chronic pain population with cLBP and associated healthcare utilization and costs using a healthcare claims database.


Eligibility criteria: Inclusion Criteria:

* chronic low back pain

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04216680: Asthma and Intimate Partner Violence
Official title: Asthma and Intimate Partner Violence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Domestic Violence
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult asthmatics ages 18-69 years who are able to participate in a questionnaire-based study.

Brief summary: This is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma as defined as postbronchodilator response of at least 12% and 200 milliliters improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity and/or evidence of positive airway hyperresponsiveness.

Exclusion Criteria:

* Medical factors that would preclude participation as determined by the investigators. Examples include blindness, mental illness that grossly impairs judgment, or active injury requiring treatment.

Primary outcomes:
measure: Asthma Control Test
timeFrame: last 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
Clinical trial NCT00297180: Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
Official title: A Double-Blind, Randomized, Placebo-controlled Study to Evaluate Weight Loss, Safety, Tolerability and Pharmacokinetics in Obese Subjects Following 12-Week Dosing of GW869682, an SGLT2 Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: hunger
obesity
sodium-dependent glucose transporter
GW869682
body composition
SGLT2 inhibitor
weight loss
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.


Eligibility criteria: Inclusion criteria:

* Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
* Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).

Exclusion criteria:

* History of eating disorders.
* Recent history of weight loss or gain.
* Had gastrointestinal surgery for treatment of obesity.
* Type 1 or type 2 diabetes mellitus.
* Have a positive urine drug screen.
* Have liver disease.
* Have hepatitis B, hepatitis C, or HIV antibodies.
* Have a thyroid disorder that is not under control with medication.
* Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
* Are unable to participate in an exercise program.
* Have used weight loss drugs within 3 months before the start of the study.
* Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or antiretroviral medications.
* Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
* High or low blood pressure.

Primary outcomes:
measure: Percentage change in body weight from baseline to Week 12.
timeFrame: from baseline to Week 12.
Secondary outcomes:
measure: Blood levels of GW869682 at the Week 2 and Week 11.
timeFrame: at the Week 2 and Week 11
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01051180: Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?
Official title: Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Piles
Bleeding
Keywords: HEMORRHOIDS
TREATMENT
PILES
BLEEDING
HALO
Lead sponsor: Poole Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study.

Brief summary: Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to piles. This study examines whether the ultrasound (doppler) is necessary to guide this tying off or not.

Detailed description: HALO (haemorrhoidal artery ligation operation) has proved to be a popular and effective treatment for bleeding piles. Currently the HALO is a Doppler guided procedure though when the Doppler mechanism does not function it has been noted that the results are similar. This prompts the question does the Doppler guide the operation to tie off the important vessels to shrink he piles, or can the vessels that underlie the visible piles be treated without Doppler. Professor Phillips from St.Marks has reviewed the protocol and agrees that it is well designed and worthwhile.

Eligibility criteria: Inclusion Criteria:

* For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study.

Exclusion Criteria:

* Other grades of piles, age outside 18-90 or other anal condition

Primary outcomes:
measure: Improvement of rectal bleeding
timeFrame: 3-6 months
Secondary outcomes:
measure: Satisfaction with the HALO procedure with or without doppler guidance
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: Poole Hospital
state: Dorset
Study officials:
References:
Clinical trial NCT01633580: D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
Official title: Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: ICSI
GnRH antagonist
corifollitropin alfa
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.

Detailed description: Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.

Eligibility criteria: Inclusion Criteria:

* \< 36 years old on day of randomisation
* FSH \< 12 (in the early follicular phase)
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
* BMI ≤ 29
* Weight \> 60 kg
* \< 3 previous trials
* ICSI
* Randomisation at out-patient clinic

Exclusion Criteria:

* ≥ 36 years old on day of randomisation
* Endometriosis ≥ grade 3
* PCOS
* Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle)
* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Primary outcomes:
measure: Consumption of rFSH at the end of the follicular phase
timeFrame: up to 9 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References:
citation: Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.
Clinical trial NCT01113580: A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population
Official title: A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2010/2011 Formulation of Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years and older at the time of the first study vaccination.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
* Clinical signs of an active infection
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry
* Females who are pregnant or lactating

Primary outcomes:
measure: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
timeFrame: Approximately 21 days after vaccination
measure: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
timeFrame: Approximately 21 days after vaccination
measure: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
timeFrame: Approximately 21 days after vaccination
Secondary outcomes:
measure: Frequency of Any Solicited Adverse Events (AEs)
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: Frequency and Intensity of Any Unsolicited Adverse Events
timeFrame: After vaccination until the end of the study; approximately 21 days
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Chiltern (Early Phase) Limited
state: Angus and Dundee
Study officials:
affiliation: Chiltern (Early Phase) Limited
name: Ronnie Beboso, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381380: Manual Therapy Treatment for Myofascial Pain
Official title: Effect of Manual Therapy After Trigger Point Injection for Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Keywords: myofascial pain
trigger point injection
manual therapy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pain intensity evaluation in patients with myofascial pain submitted kinesitherapy after trigger point injection.

Detailed description: Randomized prospective study conducted on 30 patients of both genders ranging in age from 18 to 60 years, with neck and shoulder girdle Myofascial Pain Syndrome (MFS), with a duration of ≥ 4 months and pain intensity ≥ 4.

Trigger point injection of 1 mL 0.25% bupivacaine at each point, once a week for 8 weeks (T1 to T8).

Group 1: kinesiotherapy once a week for 8 weeks Group 2: not submitted to kinesiotherapy Evaluation of pain intensity on the first assessment (T0) and after 1, 2, 3, 4, 5, 6, 7, 8, and 9 weeks

Eligibility criteria: Inclusion Criteria:

* myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4.

Exclusion Criteria:

* arrhythmia
* heart block
* coagulopathy
* cognitive alterations and infection at the site
* patients using anticoagulants, and pregnant women

Primary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Setor de Dor
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04887480: Direct Resuscitation of the Open Peritoneum
Official title: Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Wound; Abdomen
Abdomen, Acute
Wound Surgical
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 200
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 DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo
* Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
* Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent.

Exclusion Criteria:

* Patients under the age of 18
* Vulnerable populations such as pregnant women and prisoners
* Patients with open abdomens as the result of trauma
* Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).

Primary outcomes:
measure: Major Complications
timeFrame: Through study completion, an average of 6 months
measure: Number of operations and time to closure
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Length of ICU Stay
timeFrame: up to 4 weeks
measure: Time on Vasopressors
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Medical Center Fargo
state: North Dakota
Study officials:
affiliation: Sanford Health
name: Mentor Ahmeti, MD
role: PRINCIPAL_INVESTIGATOR
References: