louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00480766: A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Glucocorticoid
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture

Exclusion Criteria:

* Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years

Primary outcomes:
measure: Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo
Secondary outcomes:
measure: Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.
Clinical trial NCT01775566: Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mg
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mgafter Oral Administration in Healthy Male Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 27
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute low back pain

Brief summary: The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the Eperisone HCl SR and Myonal in healthy Korean male adults.

Detailed description: Myonal: Eperisone Hydrochloride (muscle relaxant)

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects age between 20 and 55 singed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Primary outcomes:
measure: Auclast, Cmax
timeFrame: Eperisone SR 0-24h, Myonal 0-24hr
Secondary outcomes:
measure: AUCinf, Tmax, t1/2, Css,min, Tss,max
timeFrame: Eperisone SR 0-24hr, Myonal 0-24hr
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Gyeonggi SMB Growth Accelerating Center
state: Gyeonggi do
Study officials:
affiliation: Kyungpook National University Hospital
name: Yoon Y Ran, M.D.Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06978166: Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain
Official title: Evaluating and Optimizing Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Depression, Anxiety
Keywords: JITAI
Digital mental health intervention
Older adults
Middle-aged adults
App
Smartphone
Chronic pain
Depression
Anxiety
Chatbot
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Duke University
name: Wysa
First posted: 2025-05-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.


Eligibility criteria: Inclusion Criteria:

* 45 years or older
* At least moderately severe depression and/or anxiety symptoms (Patient Health Questionnaire-9 (PHQ-9) and/or Generalized Anxiety Disorder-7 (GAD-7) score ≥ 10)
* Chronic pain (i.e., pain on most days or every day in the past three months)

Exclusion Criteria:

* Frequent active suicidal ideation
* No access to a mobile device
* Not living in the United States

Primary outcomes:
measure: Engagement
timeFrame: Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days.
Secondary outcomes:
Other outcomes:
measure: Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)
timeFrame: Baseline, Week 4, Week 8 (Not in pilot trial), Week 12 (Not in pilot trial)
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Abby L. Cheng, MD, MPHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888666: Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palatal Expansion Technique
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy

Brief summary: The aim of this study is to evaluate the periodontal effects during rapid palatal expansion (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in order to establish the possible differences and advantages of one of these treatments in periodontal terms.

Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10 patients will selected and submitted to SPE treatment. The patients will treated with the Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI; papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during the treatment (before, during and at the end). All measurements will performed by the same examiner.

A descriptive statistical analysis will conducted. The paired samples Student's T test will used to evaluate the intra-group differences between t1 and t2. The unpaired samples Student's T test will used to evaluate between groups differences at t1 and t2. The significance level will set at 95%.


Eligibility criteria: Inclusion Criteria:

* palate narrow
* necessity of performing a expansion treatment

Exclusion Criteria:

* dental disease

Primary outcomes:
measure: evaluation of periodontal health by probing pocket depth, PPD
timeFrame: Change from Baseline in probing pocket depth at 20 days and 5 months of active therapy
Secondary outcomes:
measure: valuation of periodontal health by plaque index, PI
timeFrame: Change from Baseline in plaque index at 20 days and 5 months of active therapy
measure: evaluation of periodontal health by papillary bleeding index, PBI
timeFrame: Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Dept. of Life, Health and Environmental Science, University of L'Aquila
state: AQ
Study officials:
References:
Clinical trial NCT03695666: A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic
Official title: A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ENT Disease
Lead sponsor: National Health Service, United Kingdom
Sponsor class: OTHER_GOV
First posted: 2018-10-04
Enrollment: 333
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients booked into SHO-led ENT casualty clinics

Brief summary: ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines.

Detailed description: Background The investigators' centre runs a regular ENT casualty clinic, run by an SHO, for rapid assessment and treatment of simple, acute ENT cases. ENT UK guidelines from 2017 recommend that no more than 6 patients be booked for an SHO to see during a 4-hour clinic session. This study aims to assess whether this centre meets those guidelines.

Method Data was retrospectively collected from MedWay, the centre's networked booking system. The number of patients booked for each ENT casualty clinic was counted over a period of two months. This was repeated two months after intervention to close the loop.

Result In the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. Our intervention was to inform clinic booking staff of the guidelines. In the second cycle, 20 of 24 clinics were compliant (83%).

Discussion Anecdotally, prior to intervention, SHOs would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. Clinic booking staff were not previously aware of ENT UK guidelines, and the number of clinic slots was set arbitrarily. This was easily and effectively resolved by educating staff. It can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. Further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.

Eligibility criteria: Inclusion Criteria:

* All ENT casualty clinics with patients booked within the study time period

Exclusion Criteria:

* All clinics that were not staffed by an SHO

Primary outcomes:
measure: Retrospectively counted patients booked
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: National Health Service, United Kingdom
name: Sadik Quoraishi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933166: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
Official title: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 169
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.


Eligibility criteria: Inclusion Criteria:

* On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
* Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* History of corneal refractive surgery.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Comfort After Insertion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00983866: CHOICES: Understanding Clinical Trials as a Treatment Option
Official title: Increasing Participation in Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-24
Enrollment: 1376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to determine whether having a telephone discussion with a nurse educator about making treatment decisions and participating in a clinical trial increases trial participation.

The investigators hypothesize that the participants in the intervention group will be more likely to take part in a clinical trial than those in the usual care group.


Eligibility criteria: Inclusion Criteria:

* Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases

Exclusion Criteria:

* Patients who meet specific exclusion criteria for designated clinical trials

Primary outcomes:
measure: Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials
timeFrame: Up to three months after the index oncology visit
Secondary outcomes:
measure: Proportion of patients who leave the identification and recruitment process at each step.
timeFrame: Up to three months after the index oncology visit
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Lou Fehrenbacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03063866: Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.
Official title: Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2017-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.

In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.

Detailed description: The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 40 and 60 years old.
* With Child score B or C
* Presented for elective gastrointestinal endoscopy

Exclusion Criteria:

* Emergent condition like hematemesis.
* Patients with moderate to severe hepatic encephalopathy.
* Patients with hepatopulmonary syndrome.
* Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.

Primary outcomes:
measure: Level of sedation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University Faculty of Medicine
name: Sameh Abdelkhalek Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta university Faculty of Medicine
name: Sherief Abd-Elsalam, MD
role: STUDY_DIRECTOR
References:
citation: Ahmed SA, Selim A, Hawash N, Tawfik AK, Yousef M, Kobtan A, Badawi R, Elnawasany S, Elkhouly RA, Hanafy AS, Rizk FH, Mansour L, Abd-Elsalam S. Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease. Int J Hepatol. 2017;2017:8462756. doi: 10.1155/2017/8462756. Epub 2017 Sep 26.
Clinical trial NCT00704366: AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours
Official title: A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Advanced carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
* World Health Organisation (WHO) performance status 0 to 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low hemoglobin
* Unresolved toxicity from anti-cancer therapy

Primary outcomes:
measure: The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test.
timeFrame: Assessed on an ongoing basis after starting daily dosing with AZD0530
Secondary outcomes:
measure: To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R
timeFrame: 1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.
measure: Tumor response
timeFrame: at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.
Other outcomes:
Locations:
city: Takatsuk
country: Japan
facility: Research Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
Study officials:
affiliation: AstraZeneca
name: Mary Stuart, MD
role: STUDY_CHAIR
affiliation: Saint Marianna University School of Medicine
name: Narikazu Boku, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fujisaka Y, Onozawa Y, Kurata T, Yasui H, Goto I, Yamazaki K, Machida N, Watanabe J, Shimada H, Shi X, Boku N. First report of the safety, tolerability, and pharmacokinetics of the Src kinase inhibitor saracatinib (AZD0530) in Japanese patients with advanced solid tumours. Invest New Drugs. 2013 Feb;31(1):108-14. doi: 10.1007/s10637-012-9809-7. Epub 2012 Mar 14.