louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064700: Bright Light: A Novel Treatment for Anxiety
Official title: Bright Light: A Novel Treatment for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Depression
Sleep
Keywords: Anxiety
Phototherapy
Psychic Anxiety
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Liteboook Company
First posted: 2010-02-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this research was to examine the influence of bright light on anxiety in high-anxious young adults. In an acute exposure study, participants were randomly assigned to 45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after the treatments, state anxiety, mood, and blood pressure were assessed.

Following the acute exposure study, participants performed a 5-week study. Following a a 1-week baseline, participants were randomly assigned to four weeks of daily exposure to either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion generator, which were initiated ≤1 hr after awakening. Before and after the experiment, clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following each week of treatment, blood pressure, as well as questionnaires for state anxiety, depression, mood, sleep, and side effects were assessed.


Eligibility criteria: Inclusion Criteria:

* Having a level of trait anxiety \[Spielberger State-Trait Anxiety Inventory (Form Y1)\]{23642} that was ≥ the 75th percentile for their age (i.e., ≥ 46 and ≥ 44 for women and men, respectively)

Exclusion Criteria:

* Current treatment for anxiety or depression;
* History of bipolar disorder, mania, or psychotic disorders;
* History of winter depression, which might bias towards positive response to light;
* Hypertension;
* Ophthalmic abnormalities; and
* Usual exposure to high levels of light such that the intervention would add little to usual exposure.

Primary outcomes:
measure: Spielberger State Anxiety Inventory
timeFrame: 5 weeks
measure: Hamilton Anxiety
timeFrame: 5 weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 5 weeks
measure: Pittsburgh Sleep Quality Inventory
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Chronobiology Lab, University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Southern California
name: Shawn D Youngstedt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Youngstedt SD, Kline CE, Ginsberg JP, Zielinski MR, Hardin JW. Bright light treatment for high-anxious young adults: a randomized controlled pilot study. Depress Anxiety. 2011 Apr;28(4):324-32. doi: 10.1002/da.20784. Epub 2011 Jan 19.
Clinical trial NCT02388100: The GRADE Capillary Blood Collection Pilot Study
Official title: The Glycemia Reduction Approaches in Diabetes: a Comparative Effectiveness Study (GRADE Study) Capillary Blood Collection: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: GRADE Study Group
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All GRADE study participants scheduled for a follow-up visit at selected GRADE clinical sites.

Brief summary: This pilot study is planned to validate the comparability of HbA1c results obtained from whole blood collection via venous phlebotomy versus a capillary collection of whole blood. The participant will self-collect capillary blood into HbA1c prep vials containing a buffer; these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS) mail. The feasibility of self-collection of these capillary samples by GRADE participants will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Current GRADE participant with a scheduled follow-up visit

Exclusion Criteria:

* GRADE participants attending first quarterly (Month 3) visit or an annual visit

Primary outcomes:
measure: HbA1c obtained from venous versus capillary measurements at one point in time for each participant.
timeFrame: Cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwestern American Indian Center
state: Arizona
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Honolulu
country: United States
facility: Pacific Health Research and Education Institute (VA Pacific Islands)
state: Hawaii
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: Massachusetts General Hospital
name: David Nathan, MD
role: STUDY_CHAIR
References:
citation: Nathan DM, Krause-Steinrauf H, Braffett BH, Arends VL, Younes N, McGee P, Lund C, Johnson M, Lorenzi G, Gao X, Steffes MW, Lachin JM; GRADE Research Group; DCCT/EDIC Research Group. Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies. PLoS One. 2021 Nov 15;16(11):e0257154. doi: 10.1371/journal.pone.0257154. eCollection 2021.
Clinical trial NCT00140400: Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer
Official title: Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Advanced prostate cancer
Metastatic
Hormone-refractory
GVAX
Vaccine
Allogeneic cells
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma prostate cancer
* Prostate cancer deemed to be unresponsive or refractory to hormone therapy
* An ECOG performance status of 0 or 1

Exclusion Criteria:

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* Previous chemotherapy, biological or immunotherapy for cancer
* Previous gene therapy for cancer
* Significant cancer related pain

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06409000: Evaluation of 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
Official title: 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated with electron radiation therapy at Mayo Clinic.

Brief summary: This study evaluates if three dimensional (3D) surface images can be used instead of the standard computed tomography (CT) scans for treatment planning in electron radiation therapy. 3D scanning has previously been used by several groups to design patient-specific devices to be 3D printed, and as has shown excellent agreement with CT obtained surfaces. Using 3D surface imaging instead of x-ray based CT, benefits include: no ionizing radiation used to produce images, shorter time between patient consultation and treatment, and ability to produce and evaluate patient-specific devices for electron therapy earlier in the treatment planning process. This study may help researchers learn how 3D surface scanning may be used to produce a virtual CT image of patient surfaces, and accurately replace traditional planning CT for treatment planning of electron based radiation therapy.

Detailed description: PRIMARY OBJECTIVES:

I. Develop and benchmark the necessary software to convert a 3D scan to a virtual CT.

II. Compare the spatial accuracy of virtual CTs from 3D scans to the planning CT.

III. Compare radiation treatment plans based on the virtual CTs from aim 2 to treatment plans based on the actual planning CTs.

OUTLINE: This is an observational study.

Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years old or older)
* Capable of consent
* Receiving electron therapy and a planning CT scan
* Consent to two 3D surface scans of treatment area

Exclusion Criteria:

* Pediatric patients
* Mentally incapable of study consent
* Receiving electron radiation for a breast cancer boost
* Receiving electrons for total skin electron therapy
* Patients with epilepsy or other seizure disorders

Primary outcomes:
measure: Dose distribution agreement between virtual and planning computed tomography (CT) datasets
timeFrame: Up to 2 months
measure: Geometric agreement between virtual and planning CT datasets
timeFrame: Up to 2 months
measure: Geometric agreement between 3D scans taken at different time points
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Daniel P. Harrington, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265200: Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer
Official title: Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung
Carcinoma, Small Cell Lung
Metastases
Keywords: Zometa
bone metastasis
lung cancer
non-small cell lung cancer
small cell lung cancer
bone metabolic markers
tartrate resistant acid phosphatase
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
name: Novartis Pharmaceuticals
First posted: 2005-12-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

Detailed description: The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Eligibility criteria: Inclusion Criteria:

* invasive lung cancer (small cell or non-small cell lung cancer)
* osteolytic bone metastasis determined by clinical exam, bone scan/XR
* age \> 18 years

Exclusion Criteria:

* concurrent malignancy with a second primary
* renal failure (serum creatinine \> 3mg/dl)
* pregnancy
* active rheumatoid arthritis
* intolerance to zoledronic acid

Primary outcomes:
measure: Average Percent Change From Baseline in TRAP Levels at 2 Weeks
timeFrame: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center/ University of Louisville
name: Goetz H Kloecker, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03822000: Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture
Official title: Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture: A Cross-sectional Analysis Based on Trauma Registered Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fractures
Keywords: femur fracture
trauma
fall
elderly
mortality
respiratory complication
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 2407
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria were age ≥65 years and hospitalization for the treatment of femoral fracture following a fall from standing height level (\<1 m). This study excluded those patients with a fall from ≥1 m as well as those for whom incomplete data were available.

Brief summary: This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.

Detailed description: This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.

Eligibility criteria: Inclusion Criteria:

* Patients with a fall from ≥1 m as well as those for whom incomplete data were available.

Exclusion Criteria:

* those patients with a fall from ≥1 m
* patients with incompleted data

Primary outcomes:
measure: Mortality
timeFrame: up tp 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01062100: Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Official title: The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
molecular breast imaging
MRI
gamma camera
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer


Eligibility criteria: Inclusion Criteria:

* Females ≥18 years of age
* Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:

  * Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
  * History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
  * History of Cowdens or Li Fraumeni Syndrome
  * A first degree relative with Cowdens or Li Fraumeni Syndrome
  * Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
  * Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator

Exclusion Criteria:

* Pregnant or lactating
* History of invasive breast cancer or ductal carcinoma in situ (DCIS)
* Unable to undergo MRI because of:

  * Renal dysfunction with an estimated creatinine clearance of \< 30 ml/min calculated using the Cockcroft-Gault formula
  * Implanted ferrous metal prostheses
  * Claustrophobia
  * Medical or psychological conditions that on assessment, make them unable to complete the procedure
  * Known allergies to Gadolinium-DTPA
* Known allergies to Sestamibi (Miraluma or Cardiolite)
* Prior bilateral mastectomy
* Prior breast biopsy or surgery within 3 months

Primary outcomes:
measure: To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
timeFrame: 1 year
Secondary outcomes:
measure: To explore the ability of the MBI Gamma camera to detect breast cancer.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Ontario Clinical Oncology Group - McMaster University
name: Gregory Pond
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Karen Gulenchyn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934500: CBD Knee Scope Study
Official title: Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Post-operative Pain
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 100
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: This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

Detailed description: This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.

All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
* able to complete surveys and follow-up visits

Exclusion Criteria:

* younger than 18 years of age
* history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, \*pregnancy.

Primary outcomes:
measure: Post-operative pain control
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Sleep Quality
timeFrame: 30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
state: Florida
Study officials:
References:
Clinical trial NCT06610500: Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry
Official title: Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Agranulocytosis
Keywords: Clozapine
schizophrenia
hematological monitoring
agranulocytosis
regulation
paper tracking book
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated and stabilised on clozapine by the St-Etienne Psychiatry Department Private and hospital psychiatrists in the Loire Pharmacists and hospital pharmacists in the Loire

Brief summary: Clozapine is a drug that requires regular and diligent hematological monitoring throughout its use. This follow-up is, in France, framed by a compulsory paper format of the blood count follow-up notebook for each patient. Due to the multiplicity of the different modes of transmission of the different documents necessary for compliance with the regulations for the prescription, dispensing and administration of clozapine, we decided to carry out a current inventory in the department of Loire with respect for the latter. The main objective of this study is to assess the rate of non-compliance in circuits of prescription, dispensing and administration of clozapine by sending a questionnaire on habits of prescriptions, dispensing and administration of health professionals (psychiatrists, pharmacists), and by sending a questionnaire to the patients treated by clozapine.


Eligibility criteria: Inclusion Criteria:

* Population 1: all patients stabilized of Medical-Psychological Center (CMP) of St-Etienne treated with clozapine
* Population 2 : all psychiatrists of the Loire department
* Population 2 : all pharmacists of the Loire department

Exclusion Criteria:

NA

Primary outcomes:
measure: Rate of non-compliance
timeFrame: Month: 2
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Anne-Cécile GALLO BLANDIN, MD
role: PRINCIPAL_INVESTIGATOR
References: