louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04602455: The Impact of Heartfulness Program on Loneliness in High School Students in the US
Official title: The Impact of Heartfulness Program on Loneliness in High School Students in the US
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: Heartfulness Institute
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 108
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

Detailed description: The specific aims of the study are:

1. To assess the current level of loneliness in high school students through the UCLA loneliness scale.
2. To assess the beneficial impact of the Heartfulness program on loneliness in high school students in the US.

Eligibility criteria: Inclusion Criteria:

* Participants are High School students in the US and willing to participate in the study

Exclusion Criteria:

* Non-English speaking high school students in the US and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.

Primary outcomes:
measure: Assess the current level of Loneliness
timeFrame: Baseline data through the pre-UCLA survey scores
measure: Changes in Loneliness levels
timeFrame: 28 days for 15 minutes every day based on a 28-day calendar
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ranjani B Iyer
state: Michigan
Study officials:
affiliation: Heartfulness Institute
name: Ranjani B Iyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03542955: Pulse Shortwave Therapy in Cervical Osteoarthritis
Official title: The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Osteoarthritis
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch treatment group and comparison analgesic drug therapy group . Subjects will be assessed with the Neck Disability Index (NDI) at baseline and at four weeks and VAS scores will be recorded in order to determine the efficacy of the ActiPatch device compared to Etoricoxib. Cervical osteoarthritis causes chronic neck pain which could potentially be alleviated by the ActiPatch without the use of medication.

Detailed description: Cervical Osteoarthritis causes chronic pain in the neck due to the discs of the spine breaking down, losing fluid, and becoming stiffer over time. As obesity and age increase, the likelihood of cervical osteoarthritis increases as well. When the pain caused by the broken down discs becomes severe, it may result in a loss of mobility in the neck region. Chronic neck pain has a serious impact on not only quality of life, but can also negatively affect a persons ability to lead a healthy active lifestyle. Standard analgesic therapy it limited in efficacy and can result in serious adverse effects specially with long term use.

Eligibility criteria: Inclusion Criteria:

* Chronic Neck Pain of \> 2 months
* Cervical Osteoarthritis - Radiological Evidence
* Males \& females
* Age: 30-60 years

Exclusion Criteria:

* Neck Pain \<2 months
* Pregnancy
* Irreversible neck injury
* Congenital Neurological/Muscular Diseases
* Osteo-articular Disorders
* Auto-immune Diseases
* Osteoporosis
* Hematological Diseases (Thalassemia/Sickle Cell Anemia)
* Cancer
* Contra-indication to Etoricoxib 60 mg
* Age \<30 or \>60 years

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
measure: Side Effects
timeFrame: 4 weeks
measure: Patient Satisfaction Rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tripoli
country: Lebanon
facility: New Mazloum Hospital
Study officials:
affiliation: New Mazloum Hospital
name: Rachid Mohammad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New Mazloum Hospital
name: Omar Tabbouche, Pharm D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00195455: Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
Official title: A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopause
Keywords: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 133
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.


Eligibility criteria: Inclusion Criteria:

* Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
* Intact uterus

Exclusion Criteria:

* Known or suspected breast carcinoma or estrogen-dependent neoplasm
* Undiagnosed abnormal genital bleeding

Primary outcomes:
measure: To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
Secondary outcomes:
measure: Study bleeding patterns throughout the treatment period (6 months)
measure: Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
state: Jal.
city: Monterrey
country: Mexico
state: N.l.
city: Monterrey
country: Mexico
state: N.l.
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Mexico, gomezlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03736655: Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma
Official title: Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Ciliatech
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Detailed description: 68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG Schafer 3 or 4
* Medicated IOP ≥ 21

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
* Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, ...)
* Medical treatment having intraocular hypotensive effect

Primary outcomes:
measure: Assess post-op IOP reduction
timeFrame: 6 months
measure: Assess post-op IOP clinical success
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Paris Saint Joseph
Study officials:
affiliation: Ciliatech
name: Philippe SOURDILLE
role: STUDY_DIRECTOR
References:
Clinical trial NCT00827255: Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical charts of all chronic dry eye patients who discontinued their first trial of RESTASIS® after less than 12 weeks of treatment and who started a second trial of RESTASIS® prior to June 1, 2008 will be included in the review.

Brief summary: The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Adults \>16 years of age
* Dry eye patients
* Subject with history of less than 12 weeks of initial RESTASIS® treatment
* Subject started second trial of RESTASIS® treatment prior to June 1, 2008
* First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

Exclusion Criteria:

* Patients with Contact Lens Intolerance
* Patients with Ocular Rosacea

Primary outcomes:
measure: Percentage of Patients With Complete Clearing of Corneal Staining at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Schirmer's Test at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
state: Pennsylvania
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.
Clinical trial NCT01121055: Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
Official title: Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patient Satisfaction for Bronchoscopy
Keywords: Fiberoptic Bronchoscopy
Patient
Satisfaction
Lorazepam
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during the procedure. The investigators want to evaluate whether an additional Lorazepam premedication would improve patient satisfaction for FB.

Detailed description: The enrolled patients are randomized to either the control or Lorazepam groups according to a random sample chart of numbers. The patients complete questionnaires about baseline anxiety level and satisfaction for FB within 24 hours after the FB.

Eligibility criteria: Inclusion Criteria:

* Adult patients (aged 18 years or older) admitted to the Respiratory Department

Exclusion Criteria:

* outpatient procedures
* therapeutic bronchoscopy
* expected operation or discharge within 24 hours after the FB
* sedative premedication
* endotracheal intubation with mechanical ventilation
* inability to speak Korean

Primary outcomes:
measure: patient satisfaction
timeFrame: within 24 hr of bronchoscopy
Secondary outcomes:
measure: relationship between patient satisfaction and sleep quality, anxiety level
timeFrame: 24hr before and after bronchoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
name: Seok-Chul Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01592955: Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)
Official title: Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Cyclocoagulation
HIFU High Intensity Focused Ultrasound
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients


Eligibility criteria: Inclusion Criteria:

* Refractory Glaucoma
* IOP \> 21 mm Hg
* No previous intraocular surgery or laser treatment during the 90 days before HIFU day
* Age \> 18 years
* Informed consent sgned by the subject

Exclusion Criteria:

* Normal Tension Glaucoma
* Glaucoma drainage device implanted and still present in the eye to be treated
* History of ocular or retrobulbar tumor
* Ocular infection within 14 days prior to the HIFU procedure
* Aphakic patient
* Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
* Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

Primary outcomes:
measure: Efficacy endpoint : Success / failure rate at 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Safety measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Parma
country: Italy
facility: Institute Ophthalmology - Universita di Parma
city: Torino
country: Italy
facility: Clinica Oculistica Universitaria - P-O Oftalmico
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Clinique de Montchoisi - Glaucoma center
Study officials:
affiliation: EyeTechCare
name: Laurent FARCY
role: STUDY_DIRECTOR
References:
citation: Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
Clinical trial NCT00684255: Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
Official title: Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Systemic Sclerosis
Keywords: Autoimmune Disease
Reduced Intensity Transplant
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 1
Sex: ALL
Minimum age (years): 7
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

Detailed description: This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Eligibility criteria: Inclusion Criteria:

* Diffuse Systemic Sclerosis and variants as per ACR criteria
* Medically refractory disease
* Adequate Organ Function - Pulmonary function
* Renal function, Cardiac function defined as:
* SGOT (AST) or SGPT (ALT) \<5 x upper limit of normal
* Diagnosis of SLE - Medically refractory disease

Exclusion Criteria:

* Karnofsky/Lansky \<60%

Primary outcomes:
measure: Toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Chimerism
timeFrame: 1 year
measure: Immune Reconstitution.
timeFrame: 1 year
measure: Progression Free and Overall Survival.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Mitchell Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141655: HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia
Official title: Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia, Spain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 114011
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 2023/2024 and 2024/2025 seasons.

Detailed description: The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial using the infrastructure of the Regional Vaccination Program of Galicia for patient recruitment, inclusion, randomization, and vaccine administration and the Galician health registries for data collection including baseline information, follow-up data and safety monitoring. Participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment. Informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration. The participation in the study is voluntary, and only individuals who accept signing the informed consent will be recruited. Participants may withdraw from the study at any point.

The study aims to randomize at least 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).

Eligibility criteria: Inclusion Criteria:

* 1. Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care)
* 2. Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study

Primary outcomes:
measure: Occurrence of a hospitalization due to influenza or pneumonia
timeFrame: ≥14 days after vaccination and up to May 31 the following year
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: General Public Health Directorate of Galician Health Service
state: A Coruña
Study officials:
References: