louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004200: Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official title: A Randomized Double-Blind, Placebo-Controlled Phase II Study of the Matrix Metalloprotease Inhibitor Prinomastat in Combination With Temozolomide Following Radiation Therapy in Patients Having Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-05-25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description: OBJECTIVES: I. Compare the one year survival rate and progression free survival of patients with newly diagnosed glioblastoma multiforme treated with prinomastat (AG3340) or placebo and temozolomide following radiotherapy. II. Compare the safety of these regimens in these patients. III. Compare the quality of life in these patients on these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Newly diagnosed glioblastoma multiforme Must have completed all appropriate subtotal or total surgical procedures (surgical biopsy alone not eligible) Must have received prior external beam radiotherapy No multifocal glioblastoma multiforme No radiographic disease progression during post surgical radiotherapy

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Stable steroid therapy for at least 2 weeks prior to study Radiotherapy: See Disease Characteristics No prior interstitial brachytherapy or radiosurgery Surgery: See Disease Characteristics No prior radiosurgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Agouron Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: Agouron Pharmaceuticals
name: Mary Collier
role: STUDY_CHAIR
References:
Clinical trial NCT05617300: Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Official title: Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Caregivers
Mindfulness
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the Mindfulness Based Dementia Care (MBDC) program to reduce depressive symptoms in care partners (CPs) of people living with dementia (PLWD).


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Self-identify as being an informal CP providing caregiving to a PLWD
* Register for an MBDC course through the Presence Care Website

Exclusion Criteria:

* Previous participation in an MBDC program.
* Does not speak and understand either English or Spanish.

Primary outcomes:
measure: Participation Rate
timeFrame: Baseline
measure: Completion Rate
timeFrame: 16 weeks
measure: Questionnaire Specific Response Rate
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Care Partner Burden
timeFrame: baseline, post-course at 8 weeks, follow-up at 20 weeks
measure: Change in Symptoms of Depression
timeFrame: baseline, post-course at 8 weeks, follow-up at 20 weeks
Other outcomes:
measure: Change in Self-compassion
timeFrame: baseline, post-course at 8 weeks, follow-up at 20 weeks
measure: Change in Mindful Attention Awareness
timeFrame: baseline, post-course at 8 weeks, follow-up at 20 weeks
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Leah R Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995200: Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feedback Intervention (Participants Post-stroke)
Healthy Control
Lead sponsor: Cleveland State University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in healthy individuals and individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs,

iii.) quantify and compare amount of UE use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and

iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).


Eligibility criteria: Inclusion Criteria:

* Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (AROM) in both shoulders and elbows for their age group.
* Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (UE) injury within the last 3 months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. It does not need to be their first and only stroke.

Exclusion Criteria:

* Healthy Adults: Injury of either UE within the last 3 months and unable to follow commands related to the accelerometer use/protocol.
* Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the MoCA and Stroke Impact Scale (SIS) questions.

Primary outcomes:
measure: Amount of Use (measured by accelerometer)
timeFrame: 3 week period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02107300: NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
Official title: NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Keywords: Obstructive Sleep Apnea Syndrome
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Invado Pharmaceuticals LLC
First posted: 2014-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients undergoing CPAP therapy for OSAS and improve CPAP compliance

Detailed description: Subjects diagnosed with Obstructive Sleep Apnea Syndrome (OSAS) who have started CPAP treatment and have complained of dry mouth or developed worsening of a pre-existing dry mouth as an effect of CPAP treatment will test the effectiveness of NeutraSal mouthwash in preventing or reducing his/her dry mouth perceptions and improving their compliance with CPAP.

Eligibility criteria: Inclusion Criteria:

* Patient should be above 18 years of age.
* Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
* Ability to attend visits at the research site
* Patient should be able to read and/or understand and sign the consent form be willing to participate in the research study

Exclusion Criteria:

* Patients with open mouth sores at study entry.
* Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
* Patients using any other prophylactic mouthwashes.
* Patients who are pregnant and/or nursing.
* Patients becoming pregnant during the treatment period will be removed from data.
* Patients on a low sodium diet
* Patients currently on medication or treatment for xerostomia
* Patients \< 18 years of age
* Hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate

Primary outcomes:
measure: Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire
timeFrame: Baseline through 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Chitra Lal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198900: Diabetes Knowledge Assessment
Official title: Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Knowledge Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2005-09-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition, and exercise. Although type 2 diabetics should know more about their disease and its needs, it is not expected they will know significantly more than the lay public.

Detailed description: A validated survey about diabetes, nutrition, obesity, and exercise will be dispersed to type 2 diabetics and non-diabetics, and then analyzed.

Eligibility criteria: Inclusion Criteria:

type 2 diabetic or non-diabetic, age 18 and over

Exclusion Criteria:

type 1 diabetic

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence J Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671900: Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer
Official title: The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-muscle-invasive Bladder Cancer
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 70
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: Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.


Eligibility criteria: Inclusion Criteria:

* BCG-naive patients with high-risk non-muscle invasive bladder cancer

Exclusion Criteria:

* patients in whome cystectomy is planned

Primary outcomes:
measure: Reccurence free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
Study officials:
affiliation: UHC Zagreb
name: Mirko Bakula
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063700: Impact of Non-Commercialism Policy in Seattle Schools
Official title: Impact of Non-Commercialism Policy in Seattle Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity in school aged children
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-03
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: This pilot study on the impact of a non-commercialism policy in Seattle schools will assess and evaluate obesity-related health outcomes of a real-life policy decision, recently voted on and adopted by the Seattle School Board. The policy reduces the exposure to advertising and other marketing pressures, including those from commercial food vendors.


Eligibility criteria: no restrictions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle school
state: Washington
Study officials:
References:
Clinical trial NCT05690100: Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing .
Official title: Clinical Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound After Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palate; Wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 56
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: To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.

Detailed description: To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction , Color match , Wound size closure after free gingival graft harvesting.

Eligibility criteria: Inclusion Criteria:

* Patients with mucogingival defects scheduled for free gingival graft
* Systemically healthy

Exclusion Criteria:

* Smokers
* Occlusal trauma at site of graft
* Pregnancy and lactation
* Patients allergic to the used agents
* Severe gagging reflex

Primary outcomes:
measure: Post Operative Pain
timeFrame: 14 days
Secondary outcomes:
measure: Color Match
timeFrame: 42 days
measure: Wound Size
timeFrame: 42 days
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed M barbari
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dalia M Ghalwash
role: STUDY_CHAIR
affiliation: Cairo University
name: Nesma M Shemais
role: STUDY_CHAIR
affiliation: Cairo University
name: Hisham Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.
Clinical trial NCT06094400: Pain and Stress Detection and Relief in People With Dementia
Official title: Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Chronic Pain
Perceived Stress
Keywords: dementia
pain
stress
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
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 objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.

Detailed description: This project is a Phase II clinical trial to access the feasibility and efficacy of incorporating portable EEG headband-guided meditation for alleviating pain and stress among people with early and moderate dementia in Hong Kong. Sixty dementia people will be recruited. Participants in the intervention group will wear the EEG headband and engage in 10-minute guided meditation sessions, while the control group will wear the EEG headband and undergo a 10-minute resting session. Efficacy will be evaluated using the Wong-Baker Faces Pain Rating Scale, Perceived Stress Scale, and EEG signals associated with pain and stress. Immediate post-assessment focus group interviews will be conducted to explore caregiver's experiences with the use of portable EEG headbands in this study.

Eligibility criteria: Inclusion Criteria:

* People with mild to moderate severe dementia;
* Have chronic pain or have experienced stress for at least six months;
* Be able to communicate and express pain;
* Have no prior experience with any type of meditation training;
* Volunteer to participate in the study and provide written informed consent

Exclusion Criteria:

* Person with other acute or terminal illnesses that may not be able to stay in a home living environment frequently;
* With severe visual or hearing problems that would hinder communication;
* With infectious diseases that could be transmitted by using the headband.

Primary outcomes:
measure: Changes on pain level
timeFrame: Pre-intervention, immediately post-intervention
Secondary outcomes:
measure: Changes on stress level
timeFrame: Pre-intervention, immediately post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00625300: Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease
Official title: Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: repetitive transcranial stimulation
Parkinson's Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2008-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
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 effects of deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to establish its safety in this population.

Detailed description: Study rational:We anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.

Design:A prospective, double blind sham-controled study. No. of centers:1 One: Tel-Hashomer Medical Center, affiliated to Sackler school of Medicine, Tel -Aviv University, Israel.

Study Population:Forty patients with idiopathic PD, Hoehn and Yahr stages II to IV, on stable antiparkinsonian therapy, with partial response.

Study Duration:Two years

Eligibility criteria: Inclusion Criteria:

* PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off". Participants on antidepressants should be at least 2 months on stable therapy.

Exclusion Criteria:

* Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
* Patients on neuroleptics.
* Patients with dementia or any unstable medical disorder.
* History or current hypertension.
* History of head injury or neurosurgical interventions.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
* History of migraine or frequent or severe headaches.
* History of hearing loss.
* The presence of cochlear implants
* History of drug abuse or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Participation in current clinical study or clinical study within 30 days prior to this study.

Primary outcomes:
measure: Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
timeFrame: 10-90 days
Secondary outcomes:
measure: Clinical Global Impression of Severity (CGIS)
timeFrame: 10-90 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Tel Hashomer
Study officials:
References: