louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00461032: Montelukast Back to School Asthma Study (0476-340)
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 1162
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.


Eligibility criteria: Inclusion Criteria:

* Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

* Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Primary outcomes:
measure: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
timeFrame: 8 Week treatment period initiated at the beginning of a school year
Secondary outcomes:
measure: Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
timeFrame: 8 Week treatment period initiated at the beginning of a school year
measure: Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
timeFrame: 8 Week treatment period initiated at the beginning of a school year
measure: Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
timeFrame: 8 Week treatment period initiated at the beginning of a school year
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1.
Clinical trial NCT01229852: Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
Official title: Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Transcranial Magnetic Stimulation
Pain
Lead sponsor: Cervel Neurotech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia.

The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria.
* Moderate or severe pain from fibromyalgia despite current treatment regimen.
* Will not become pregnant during study.

Exclusion Criteria:

* Seizure disorder.
* Metal implants on or in brain, spinal cord, ear, eye or heart.
* Current use of proconvulsant medications (e.g., bupropion).
* Taking oral amitriptyline \> 100 mg once daily at bedtime.
* Nonscheduled analgesic, anticonvulsant or antidepressant medications.
* Severe depression or suicidality.
* Other significant psychiatric disorder.
* Previous use of TMS.

Primary outcomes:
measure: Change from Baseline on the Brief Pain Inventory (BPI)
timeFrame: Daily during 20 day treatment
Secondary outcomes:
measure: Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)
timeFrame: 1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment
measure: Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 1, 10 day of treatment; 1 day and 4 weeks post treatment
measure: Durability, safety and tolerability
timeFrame: Measured weekly up to 1 month after treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premier Research Group
state: Arizona
Study officials:
affiliation: Cervel Neurotech, Inc.
name: M. Bret Schneider, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00214032: Pycnogenol for the Treatment of Lymphedema
Official title: Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphedema
Keywords: lymphedema of the arm in breast cancer survivors
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-09-21
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.


Eligibility criteria: Inclusion Criteria:

* \> 6 months from last surgical and/or radiation treatment to the affected axilla
* Unilateral lymphedema of the upper extremity

Exclusion Criteria:

* May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study

Primary outcomes:
measure: reduction of arm lymphedema
timeFrame: monthly
Secondary outcomes:
measure: comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire
timeFrame: monthly
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul R Hutson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02765932: The Effect of a Psychosensory Therapy
Official title: The Effect of a Psychosensory Therapy on Post-Op Pain in Hip and Knee Surgery: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Replacement Surgery
Keywords: Hip
Knee
replacement
surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 50
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: This is a prospective study looking at the impact of psychosensory therapy and how it can diminish pain and consumption of pain medications. The primary study objective is to evaluate the change in Visual Analogue Score (VAS) score assessing for pain from Baseline, every day of inpatient stay, 7 days after leaving hospital (via phone), and 3 months post-op(via phone) and to correlate the psychosensory therapy and overall use of pain medications/narcotics.

Detailed description: The study will aim to enroll 50 subjects. 25 subjects will receive placebo therapy which will be dummy movements while the other 25 will receive psychosensory therapy. The treatment group will involve a touch technique called havening.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing joint replacement surgery (Hip and Knee Only)
* Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria:

* Patients who have undergone joint replacement surgeries
* History of Chronic Narcotic Use (more than 30mg morphine dose)

Primary outcomes:
measure: Change in pain from baseline using Visual Analogue Score (VAS)
timeFrame: Baseline and 7 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748032: Short-term Cognitive Training in Late-life Depression
Official title: The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: depression
intervention studies
Lead sponsor: Rotman Research Institute at Baycrest
Sponsor class: OTHER
Collaborators: name: Baycrest
First posted: 2012-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 55
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 examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD).

The hypotheses are:

1. post-training cognitive performance will be superior to pre-training cognitive performance
2. post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
3. AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age \>=55
* Proficiency in English
* Current depressive episode and meet criteria for DSM-IV major depressive disorder
* Hamilton Depression Rating Scale score \>=15
* Able to give informed consent
* Stable medication dosages during the training period

Exclusion Criteria:

* Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders
* Mini-Mental State Examination score of \<26
* Diagnosis of dementia
* Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)
* Unstable medical illnesses requiring active treatment
* Vision or hearing impairment affecting ability to participate in training

Primary outcomes:
measure: Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed
timeFrame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
Secondary outcomes:
measure: Changes in mood including depression, anxiety and apathy
timeFrame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Rotman Research Institute at Baycrest
state: Ontario
Study officials:
affiliation: Rotman Research Institute at Baycrest
name: Linda Mah, MD, M.H.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06985732: Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR
Official title: Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Centre Médical Porte Verte
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks.

Detailed description: Patients meeting the inclusion criteria and agreeing to participate in the study will be enrolled and then randomized to either the VR immersion group or the control group. Patients included in the protocol will not undergo any changes to their care. Patients in the experimental group will receive 12 virtual reality sessions in addition to their usual care.

Eligibility criteria: Inclusion Criteria:

People hospitalized in the SMR unit at La Porte Verte Hospital for a minimum of 3 weeks,

* People with preserved or slightly impaired cognitive status with an MMSE ≥ 20,
* People who have been informed and have signed written informed consent

Exclusion Criteria:

People under guardianship or curatorship,

* People with difficulty understanding the VR study and materials,
* People with vision problems that impact the use of VR,
* People with hearing problems that impact the use of VR,
* People with epilepsy,
* People at risk of nausea and dizziness when using the VR headset,
* People who cannot tolerate the VR headset,
* Not affiliated with a social security scheme.
* People receiving care with reflexology and relaxation massage

Primary outcomes:
measure: WHO-5
timeFrame: 4 times throughout of study at baseline and after each VR session
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05588232: the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
Official title: Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Drug Sedation
Coronarography
Angiography
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, prospective, comparative, randomized, open-label study.
Primary purpose: OTHER

Brief summary: Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.

The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)
* Affiliation to a social security scheme or beneficiary of such a scheme.
* Patient having signed the free and informed consent

Exclusion Criteria:

* Dementia
* Language barrier
* Claustrophobia
* Nausea
* History of intolerance to Virtual Reality
* Patient with epilepsy
* Refusal to participate in the study
* Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Unstable patient (state of shock, respiratory or neurological distress)

Primary outcomes:
measure: Maximum pain during the interventional cardiology procedures
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: Clinique Claude Bernard
Study officials:
References:
Clinical trial NCT06457932: Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.
Official title: Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress and Anxiety Levels in University Undergraduate Students.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety State
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.


Eligibility criteria: Inclusion Criteria:

1. Second- and third-year students of the Physiotherapy Degree at various universities in the province of Seville.
2. Enrolled in all courses for the academic year.
3. Enrolled in the courses for the first or second time.

Exclusion Criteria:

1. Having a job in addition to academic responsibilities.
2. Having a dependent family member under their care.
3. Diagnosed with any mental health issues.
4. Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.
5. Simultaneously pursuing another degree or a dual degree program.

Primary outcomes:
measure: Stress
timeFrame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
measure: Anxiety State
timeFrame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
measure: Academic Performance
timeFrame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
measure: Adherence
timeFrame: Daily during the 8 week intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Seville
name: Hermann Fricke-Comellas, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05337332: Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
Official title: Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Central Serous Chorioretinopathy
Irvine-Gass Syndrome
Pars Planitis
Cystoid Macular Edema
Keywords: Central serous chorioretinopathy
Cystoid macular edema
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.

Detailed description: Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.

Exclusion Criteria:

* other retinal diseases that may affect CMT and final visual outcome.
* Patients with dense corneal opacity.

Primary outcomes:
measure: Central macular thickness
timeFrame: Baseline and 12 months after injection.
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: Baseline and 12 months after injection.
Other outcomes:
measure: Intraocular pressure
timeFrame: Baseline and 12 months after injection.
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06034132: Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid
Official title: Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid


Eligibility criteria: Inclusion Criteria:

* Patients with no systemic and/or oral health disease
* absence of any lesions in the oral cavity
* wide band of keratinized tissue more than 1mm at implant site

Exclusion Criteria:

* smoking more than 20 cigarettes per day
* localized radiation therapy of the oral cavity,
* antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity

Primary outcomes:
measure: Change in MMP8 levels
timeFrame: at 2 weeks and 4 weeks
Secondary outcomes:
measure: Change in gingival condition
timeFrame: at 2 weeks and 4 weeks
measure: Change in gingival bleeding
timeFrame: at 2 weeks and 4 weeks
measure: Change in plaque accumulation
timeFrame: at 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: