louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00432237: Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 1703
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 purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.


Eligibility criteria: Inclusion Criteria:

* Patient has at least 1 year history of migraine (with or without aura)
* Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria:

* Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
* Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
* Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has a history of cancer within the last 5 years

Primary outcomes:
measure: Number of Patients Reporting Pain Freedom at 2 Hours Postdose
timeFrame: 2 hours post dose
measure: Number of Patients Reporting Pain Relief at 2 Hours Post Dose
timeFrame: 2 hours post dose
measure: Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
timeFrame: 2 hours post dose
measure: Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
timeFrame: 2 hours post dose
measure: Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
timeFrame: 2 to 24 hours postdose
measure: Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
timeFrame: 2 to 24 hours postdose
measure: Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
timeFrame: 2 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.
Clinical trial NCT05972837: Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome
Official title: Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Pain Syndrome of Neck
Keywords: Myofascial Pain Syndromes
Surface electrical stimulation
Remote medical support
Telemedicine
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the developed home-based surface electrical stimulation program to the controls in computer office workers with MPS.

Detailed description: Cervical myofascial pain syndrome (MPS) is a common problem among workers who have large amount of computer use. Additionally, owing to the high workload and long hours of staying in thier cubicle, the office employees are often unable to have extra time to receive rehabilitation and treatment regularly. A home-based surface electrical stimulation (SES) program is developed to help intervention be time-saving and more accessible for office-based staff busy at work.

In this single-blind randomized controlled trial, participants will be assigned to one of the following three groups and undergo 3 weeks (20 minutes/ time, three times/ week) of intervention:

1. SES combined with telemedical support
2. SES
3. No intervention

The outcome assessments will be performed before and after the intervention (0-wk and 4-wk) and 4 weeks after the endpoint of intervention (8-wk). The outcome assessor was blind to the intervention and group allocation.

Eligibility criteria: Inclusion Criteria:

* Time of using computer \> 4hrs/day
* Neck pain \> 2 months
* Diagnosis of cervical myofascial pain syndrome
* VAS pain ≥ 3 (0\~10)

Exclusion Criteria:

* Had a history of neck surgery
* Pregnancy
* Systematic disease (e.g. autoimmune disorders, arthritis, infection, etc.)
* Malignancy
* Neurological signs such as radiating pain, motor weakness in the upper extremities.
* Skin defect or scars at the planned placement of SES
* Pacemaker user
* History of seizure attack
* History of diabetes
* Fear of receiving SES

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Range of motion of the neck
timeFrame: 8 weeks
measure: Pain pressure threshold (kg/m2)
timeFrame: 8 weeks
measure: Neck disability index (NDI, 0~100%)
timeFrame: 8 weeks
measure: Beck Anxiety Inventory (BAI, scoring from 0~63)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
References:
Clinical trial NCT00536237: MK0524A Phase IIb Study (0524A-011)(COMPLETED)
Official title: Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Flushing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.

Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking \> 50mg at screening
* Must be willing to complete electronic diary

Exclusion Criteria:

* Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
* You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
* You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

Primary outcomes:
measure: To determine the effect of MK0524A on lipids and blood glucose
timeFrame: 17 Weeks
Secondary outcomes:
measure: To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
timeFrame: 17 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.
Clinical trial NCT03566537: Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease
Official title: Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Thyroid Nodule
Quality of Life
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female subjects with benign thyroid diseases 18 years of age or older scheduled for thyroidectomy

Brief summary: To detect any changes in Quality of Life in patients with benign thyroid diseases who undergo thyroidectomy compared to patients with benign thyroid diseases and conservative treatment and healthy subjects.

Detailed description: Benign thyroid diseases are a common public health problem. It has been reported that thyroid diseases can affect Quality of Life (QoL), but this is not easy to be assessed. Therefore, a valid instrument is necessary. Such an instrument is Thyroid-related patient-reported outcomes questionnaire (ThyPRO). ThyPRO has been recently translated and validated in Greek language. The questionnaire consists of 85 items grouped in 14 scales concerning goiter, hypothyroidism, hyperthyroidism and eye symptoms, tiredness, cognitive impairment, anxiety, depression, emotional susceptibility, cosmetic complaints and impaired social, and daily and sex life, as well as overall quality of life.

A few studies have demonstrated that various thyroid therapies may improve some aspects of QoL. The aim of the present study is to address the impact of thyroidectomy in QoL in patients with benign thyroid diseases.

Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old
2. Patient scheduled for a non-emergency operation
3. Patient diagnosed with benign thyroid disease

Exclusion Criteria:

1. Patient is participating in another clinical trial which may affect this study's outcomes
2. Patient with thyroid cancer
3. Previous operation at the thyroid and parathyroid glands or neck irradiation
4. Patient unable to read and write in Greek

Primary outcomes:
measure: Alterations in Quality of Life after thyroidectomy for benign thyroid disease
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Ahepa Hospital
state: Central Macedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Theodosios Papavramidis, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06006637: Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
Official title: Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Transcranial photobiomodulation
Autism Spectrum Disorder
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: JelikaLite LLC
First posted: 2023-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
Primary purpose: TREATMENT

Brief summary: This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University with 40 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.

Detailed description: The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University with 40 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.

Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.

Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.

Eligibility criteria: Inclusion Criteria:

* Ages 2 - 8
* Autism spectrum disorder diagnosis
* CARS-2 score of 30 - 45

Exclusion Criteria:

* CARS scores less than 30 or over 45.
* Taking psychotropic medications.
* Having skin lesions on scalp
* Having history of seizures
* Having history of abnormal EEG
* Being a relative of the PI or a researcher
* Having implanted devices (including cochlear implants).

Primary outcomes:
measure: Childhood Autism Rating Scale, Second edition
timeFrame: 10 weeks
Secondary outcomes:
measure: Social Responsiveness Scale, Second Edition
timeFrame: 10 weeks
measure: Clinical Global Impressions Scale
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Golisano Center for Special Needs
state: New York
Study officials:
References:
Clinical trial NCT01901237: Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
Official title: Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: Cancer
Adolescent and Young Adult
Exercise
Physical Activity
Quality of Life
End-of-Life
Palliative
Terminal
Yoga
Alternative Therapies
Fitness
Fatigue
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: IWK Health Centre
name: Nova Scotia Health Authority
First posted: 2013-07-17
Enrollment: 5
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a non-curative cancer and assigned to non-curative or palliative care
* Between 15-39 years of age
* Have primary physician/oncologist consent to participate

Exclusion Criteria:

* Experience any medical conditions that contraindicate yoga (e.g., bone metastases)
* Exhibit cognitive limitations (e.g., psychiatric disorders)
* Score below 30% on Palliative Performance Status Scale

Primary outcomes:
measure: Feasibility: Recruitment
timeFrame: Final: end of week 7
measure: Feasibility: Retention
timeFrame: Final: end of week 7
measure: Feasibility: Adherence
timeFrame: Final: end of week 7
measure: Safety
timeFrame: Final: end of week 7
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: Baseline: week 1; Final: week 7
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority, Halifax, Canada
name: Rob Rutledge, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04041037: The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series
Official title: The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pilonidal Disease
Keywords: ACell
ACell MicroMatrix®
ACell Cytal® Wound Matrix
Urinary Bladder Matrix
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the medical offices of the Principal Investigator, Dr. Massarotti, and CO-Investigator, Dr. Chudzinski.

Brief summary: A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.

Detailed description: This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.

Eligibility criteria: Inclusion Criteria:

1. Subject has a clinical diagnosis of pilonidal disease.
2. Subject is being scheduled for surgical excision of pilonidal disease.
3. Subject is at least 18 years of age.
4. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
5. Subject is willing to provide written informed consent.

Exclusion Criteria:

1. Subject has a known allergy to porcine-based materials.
2. Subject is pregnant

Primary outcomes:
measure: Rate of Wound Closure
timeFrame: Up to 3 month visit
Secondary outcomes:
Other outcomes:
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: Up to 3 month visit
measure: Katz Index of Independence in Activities of Daily Living (KATZ ADL)
timeFrame: Up to 3 month visit
measure: Wound Related Adverse Events
timeFrame: Up to 3 month visit
Locations:
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
Study officials:
affiliation: Florida Hospital Tampa
name: Haane Massarotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069237: Compliance and Contamination in Soft Contact Lens Wearers
Official title: Compliance and Contamination in Soft Contact Lens Wearers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Lens Wear
Keywords: contact lens wear
multi-purpose solution
corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contact Lens Wearers

Brief summary: The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.

Detailed description: The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.

Eligibility criteria: Inclusion Criteria:

* Successful contact lens wear on a daily wear basis
* Normal Eyes

Exclusion Criteria:

* Topical ocular medication use
* No active ocular issues

Primary outcomes:
measure: Microbial colonization on soft contact lenses and lens cases associated with daily lens wear
timeFrame: 2 weeks
Secondary outcomes:
measure: Regimen compliance
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern
role: STUDY_DIRECTOR
References:
Clinical trial NCT02330237: Natural Gels for Treatment of Plaque Psoriasis
Official title: Safety and Efficacy of Natural Gel Combination and Hair Mask of Plant Origin in Patients With Psoriasis: A Randomized, Double-Blind, Placebo (Vehicle) Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parapsoriasis
Lead sponsor: Secret of Youth
Sponsor class: INDUSTRY
First posted: 2015-01-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety and the therapeutic activity of the combination of Natural Gel combination and hair mask of plant origin in patients with mild to moderate plaque psoriasis.

Detailed description: This is a random, double blind placebo -vehicle- controlled study. Patients recruiting and inclusion into the study is well defined. Expert on site monitoring will assure execution of all assignments as detailed in the protocol (screening, consent form, double-blind group assignment) .

Statistical analysis:

* It is calculated that 52 patients will be needed for this study.
* Type I error probability associated with this test is 0.05 .
* Uncorrected chi square will be used to assess changes in the measured variables.

Eligibility criteria: Inclusion Criteria:

1. Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
2. Male and female ≥ 18 years old.
3. Subject is capable of giving a written informed consent.

Exclusion Criteria:

1. Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
2. Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
3. Subjects with any other type of psoriasis but vulgaris (plaque ).
4. Use of investigational agents \< 30 days prior to the study.
5. Low compliance.
6. Subjects who are mentally or physically unable to comply with all aspects of the study.
7. Pregnant women.
8. Known allergic reaction to fragrance or any ingredient of the test products.
9. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
10. A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.

Primary outcomes:
measure: Modified Psoriasis Assessment severity index
timeFrame: up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reamat- Gan
country: Israel
facility: Chaim Sheba Med. center. Dept. Of Dermatology
state: Ramat-almogi
Study officials:
affiliation: Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel
name: Felix Pavlotzky, MD
role: PRINCIPAL_INVESTIGATOR
References: