louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00520728: Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
Official title: Efficacy of an Occupational Time Use Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Serious Mental Illness
Keywords: Schizophrenia
Psychosis
Occupational Disengagement
Occupational Imbalance
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2007-08-24
Enrollment: 18
Sex: ALL
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: The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention designed to increase activity participation and improve meaning in the lives of people with serious mental illness living in the community.

Detailed description: 5 Assertive Community Treatment (ACT) Teams from Kingston (n=2), Belleville (n=1), and Ottawa (n=2) will be involved in a 12 week randomized controlled trial of our Time Use Intervention. 20 subjects (4 subjects from each team) will participate in this pilot study and will be treated individually by their ACT team Occupational Therapist (1 OT per ACT Team). This pilot test will help to determine the clinical utility and efficacy of our treatment protocol.

Comparison: Standard ACT treatment with the Occupational Time Use Intervention vs. Standard ACT treatment

Eligibility criteria: Inclusion Criteria:

* Adults (18-65 years of age);
* Primary diagnosis of a severe psychiatric disorder with a psychotic feature;
* Team and self-perceived occupational disengagement (low activity levels);
* Fluent in English;
* Living in a community setting and receiving ACT treatment;
* Own legal guardian (thus competent to give consent to participate), and are willing to give written informed consent to participate in the study.

Exclusion Criteria:

* Unstable mental health;
* Lack of interest in a time use intervention;
* Satisfied with current time use and occupations;
* ACT Team Occupational Therapist is subject's main Case Manager.

Primary outcomes:
measure: Change in Activity Level using a 2 day (48 hour) time use diary
timeFrame: Participants were tested at baseline and after 12 weeks of treatment.
measure: Occupational Engagement using 1. 48 hour time use diary for occupational balance, 2. Engagement in Meaningful Activities Survey (EMAS) for meaning of activities, and 3. Profiles of Engagement in People with Schizophrenia (POES) to rate engagement.
timeFrame: Participants were tested at baseline and after 12 weeks of treatment.
Secondary outcomes:
measure: Clinical Utility using feedback from Therapists and Treatment Subjects
timeFrame: Participants were tested after 12 weeks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Megan M Edgelow, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: Terry Krupa, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01621828: Multimedia Information and Pre-operative Anxiety
Official title: A Prospective Randomised Controlled Trial of the Impact of Multimedia Information to Reduce Pre-operative Anxiety in Patients Undergoing Major Elective Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Keywords: pre-operative anxiety
multimedia information
operating theatre
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate a possible reduction in pre-operative anxiety in patients undergoing major elective surgery, by providing multimedia information regarding the patient pathway to and from the Operating Theatre.

Detailed description: To determine whether multimedia information reduces the level of pre-operative anxiety in patients undergoing major elective surgery. To evaluate the efficacy of a video, showing the patient pathway to and from the Operating Theatre, compared with standard information, a written leaflet, about the operating room experience and environment.

Eligibility criteria: Inclusion Criteria:

Adult patients undergoing major elective surgery, never previously undergoing surgery as an adult (\>18) and admitted to hospital at least one day before the scheduled surgery.

Exclusion Criteria:

* Patients unable to give consent.
* Patients not able to watch the video.
* Patients admitted the same day of the planned surgery.
* Patients not at the first experience of surgery as an adult (\>18).

Primary outcomes:
measure: pre-operative anxiety
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Valeria Silvestre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429728: A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
Official title: An Open-Label, Parallel Group, Single Session Study Comparing the Pharmacokinetics of a Single Oral Dose of GW876008 Administered to Healthy Volunteer Smokers and Healthy Volunteer Non-Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics,
tolerability,
healthy,
subjects,
smokers,
non-smokers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females.
* Normal ECG.
* Non-smokers (abstinence from smoking for at least 6 months before the start of the study) or smokers who smoke between 10 and 30 cigarettes, inclusive, per day, for at least 2 months prior to screening.
* Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Active peptic ulcer disease.
* Positive faecal occult blood.
* Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
* Female subjects who are currently or who are planning to become pregnant or who are lactating (from screening through at least 8 weeks after receiving study drug).

Primary outcomes:
measure: Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
timeFrame: on Day 1 at pre-dose and over 72 hours post-dose.
Secondary outcomes:
measure: 12-lead ECG on day 1, 24 hours post dose, & follow up
timeFrame: on day 1, 24 hours post dose, & follow up
measure: vital signs at screening & day 1 through 72 hours post dose
timeFrame: at screening & day 1 through 72 hours post dose
measure: adverse events day 1 through 72 hours post dose
timeFrame: day 1 through 72 hours post dose
measure: clinical laboratory data day 1 through 24 hours post dose
timeFrame: day 1 through 24 hours post dose
Other outcomes:
Locations:
city: Willingboro
country: United States
facility: GSK Investigational Site
state: New Jersey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MBChB, MFPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01801228: Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects
Official title: Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ascites
Cirrhosis
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Uppsala University Hospital
name: Karolinska University Hospital
name: University Hospital, Linkoeping
name: University Hospital, Umeå
name: Region Örebro County
First posted: 2013-02-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.


Eligibility criteria: Inclusion Criteria:

Male Ascites Cirrhosis

-

Exclusion Criteria:

Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists

Primary outcomes:
measure: Ascites
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University Hospital of Skane
state: Skane
Study officials:
References:
Clinical trial NCT03323593: Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine
Official title: Crossover Pharmacokinetic Study of Two Mode of Administration of Intranasal Dexmedetomidine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bioavailability
Dexmedetomidine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®).

Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.

Detailed description: This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.

Eligibility criteria: Inclusion Criteria:

healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -

Exclusion Criteria:

-

Primary outcomes:
measure: Bioavailability of dexmedetomidine
timeFrame: 8 hours
Secondary outcomes:
measure: sedation score
timeFrame: 8 hours
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT00698893: Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Official title: An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Simplex
Keywords: Herpes simplex
Herpes simplex candidate (gD) vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years of age
* Seropositive for antibodies against HSV
* Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
* Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

* Any abnormal laboratory value among the tests performed at screening.
* History of persistent hepatic, renal, cardiac or respiratory diseases
* Clinical signs of acute illness at the time of entry into the study.
* Previous history of asthma or hypersensitivity to drugs.
* Seropositive for antibodies against the human immunodeficiency virus
* Pregnancy and lactation.
* Treatment with corticosteroids or immunomodulating drugs.
* Simultaneous participation in another clinical trial.
* Administration of any other vaccine or immunoglobulins during the study period

Primary outcomes:
measure: To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
timeFrame: Throughout the study
measure: Measurement of haematology/biochemical parameters on blood samples
timeFrame: Throughout the study
measure: Vaccine reactogenicity by soliciting of local and general signs/symptoms
timeFrame: On the day of vaccination and the subsequent 7 days
measure: Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
timeFrame: From day 0 to day 45 following vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
Clinical trial NCT00130793: A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
Official title: A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-16
Enrollment: 368
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Detailed description: The duration of treatment is 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion Criteria:

* Prior history of herpes zoster (shingles)
* Prior receipt of varicella or zoster vaccine
* Immunosuppressed

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks
Secondary outcomes:
measure: Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
timeFrame: 4 weeks
Other outcomes:
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
timeFrame: From prevaccination (baseline) to 4 weeks postvaccination
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schodel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. doi: 10.1128/CVI.00310-07. Epub 2007 Dec 12.
Clinical trial NCT05749393: Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm
Official title: Effect of Heparinization on Intracranial Aneurysm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysm
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.


Eligibility criteria: Inclusion Criteria:

1. Greater than 18 years old, less than 75 years old
2. Patients with unruptured intracranial aneurysm were confirmed by DSA.
3. Coagulation function should be normal in the enrolled patients.

Exclusion Criteria:

1. Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation.
2. Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).

Primary outcomes:
measure: Size of the ischemic focus
timeFrame: This will be evaluated within 24 hours after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
Study officials:
affiliation: First Affiliated Hospital, Nanjing Medical University
name: Hua Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Zhou X, Liu Y, Ding C, Wang Y, Yang H. The Utility of Diffusion-Weighted MRI Lesions to Compare the Effects of Different Heparinization Schemes in Intracranial Aneurysms Treated by Endovascular Intervention. Front Neurol. 2020 Dec 10;11:609384. doi: 10.3389/fneur.2020.609384. eCollection 2020.
citation: Narata AP, Amelot A, Bibi R, Herbreteau D, Angoulvant D, Gruel Y, Janot K. Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms. Neurosurgery. 2019 Jan 1;84(1):77-83. doi: 10.1093/neuros/nyy002.
Clinical trial NCT01763593: Safety and Surgical Performance Study of Aurosleek Surgical Blades
Official title: A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: Patients having cataract
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 35
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 undergoing cataract surgery would be included in this observational study

Brief summary: To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.

Detailed description: Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.

Eligibility criteria: Inclusion Criteria:

* Senile cataract
* Willing to give written informed consent
* Ability to follow study instructions and likely to complete required visits.

Exclusion Criteria:

* Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
* Traumatic cataract
* Uveitis and Complicated cataract
* One eyed patients

Primary outcomes:
measure: Physioclinical Characters
timeFrame: 30 days
Secondary outcomes:
measure: Post operative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamilnadu
Study officials:
affiliation: Medical Officer
name: Neeraj Kumar Agrawal, MS
role: PRINCIPAL_INVESTIGATOR
References: