louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05248256: Vertebral Marrow Attention Trial (VMAT)
Official title: Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 12
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 see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.


Eligibility criteria: Inclusion Criteria:

* Adult patient \> 18 years
* Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer)
* Patients with oligometastatic disease stage IV, M1 disease, in which definitive concurrent chemoradiotherapy to the thorax is planned
* CBC/CMP within these limits
* Absolute lymphocyte count\>500/ml
* Hemoglobin\>8 g/dL
* AST (aspartate aminotransferase)/ALT (alanine transaminase) \<2.5 times of ULN
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* History of thoracic irradiation
* History of palliative radiation for the current malignancy under consideration
* Patients not being treated with definitive standard of care to the chest
* History of bone marrow disease and or leukemia
* History of prior cytotoxic chemotherapy for a disease other than for the current malignancy
* Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases
* Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise

Primary outcomes:
measure: Limited G3L Toxicity
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline to study end (up to 5 years)
measure: Progression free Survival (PFS)
timeFrame: Baseline to study end (up to 5 years)
measure: Local Recurrence (LR)
timeFrame: Baseline to study end (up to 5 years)
measure: Metastasis Free Survival (MFS)
timeFrame: Baseline to study end (up to 5 years)
measure: Change in Neutrophil to Lymphocyte ratio (NLR)
timeFrame: Baseline to study end (up to 5 years)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Service for Timely Access
state: Tennessee
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center - Mays Cancer Center
name: Neil Newman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194556: Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Official title: Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.


Eligibility criteria: Inclusion Criteria:

* Stage IV or IIIB advanced non-small cell lung cancer patients
* Positive EGFR Mutation
* Non-progressive disease after first-line gemcitabine/cisplatin therapy
* Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion Criteria:

* Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
* Patients with wild-type EGFR
* Evidence of interstitial lung diseases
* Severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Primary outcomes:
measure: Progression Free Survival
timeFrame: 15 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Objective response rate
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
Other outcomes:
Locations:
city: NanNing
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Xiaohua Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019156: Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults
Official title: Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study explored whether exercise video distribution using metaverse space is effective in increasing physical activity among young people, along with mental health and locomotive function. This is a randomized parallel-group study. Participants will be assigned to 3 groups: a metaverse group, a YouTube group, and a control group. The metaverse group will receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will receive access to the same exercise videos as the metaverse group. The control group was given no specific instructions.

The intervention period was 8 weeks, and physical activity and other items were measured before and after the intervention. These pre- and post-intervention measurements will be used to determine whether the delivery of exercise videos via Metaverse is effective in increasing physical activity in young adults.


Eligibility criteria: Inclusion Criteria:

* individuals aged 18-30 at the time of obtaining consent
* who owned a smartphone or computer and had internet access
* who did not belong to an exercise community, such as a sports club

Exclusion Criteria:

* individuals who had a history of a disease that prohibited exercise
* individuals whose physical activity was \> 3000 metabolic equivalents of task (METs)/week
* pregnant (or possibly pregnant) women

Primary outcomes:
measure: Physical activity
timeFrame: The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.
Secondary outcomes:
measure: Well-being
timeFrame: Pre- and post- 8 weeks intervention
measure: Psychological distress
timeFrame: Pre- and post- 8 weeks intervention
measure: Locomotive syndrome risk tests
timeFrame: Pre- and post- 8 weeks intervention
measure: Social capital
timeFrame: Pre- and post- 8 weeks intervention
measure: Quality of life (QOL)
timeFrame: Pre- and post- 8 weeks intervention
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Yukio Urabe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03703856: Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Official title: Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Alzheimer Disease
Alzheimer
AD
Alzheimer's
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested


Eligibility criteria: Inclusion:

1. Alzheimer's Disease Research Center-confirmed diagnosis of AD
2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24
3. Age 50-83 y
4. Knowledgeable caregiver
5. Ambulatory
6. Medically stable;
7. Audiometric testing (detection \< 40 db(A) at 1000 Hz)
8. Informed consent

Exclusion:

1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
2. Current psychiatric or neurologic illness other than AD
3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)
4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor
5. Investigational drug treatment \< 30 d of screening
6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids
7. Positive urine toxicology for non-prescribed psychoactive substance
8. Actively enrolled in cognitive remediation therapy

Primary outcomes:
measure: Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks
timeFrame: 0, 8, 16, 24 weeks
Secondary outcomes:
measure: Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks
timeFrame: 0, 8, 16, 24 weeks
Other outcomes:
measure: Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks
timeFrame: 0, 8, 16, 24 weeks
Locations:
city: San Diego
country: United States
facility: Clinical Teaching Facility (CTF-B102) at UCSD Medical Center
state: California
Study officials:
affiliation: UCSD
name: Neal Swerdlow, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00635856: Open Label Trial to Assess Iressa in Prostate Cancer Patients
Official title: Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Iressa
Gefitinib
Prostate Cancer
PSA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels


Eligibility criteria: Inclusion Criteria:

* Prostate cancer diagnosis
* no evidence of metastasis
* Age 18 or older

Exclusion Criteria:

* Prior chemotherapy for recurrent prostate cancer
* Radiotherapy completed within 28 days of starting the study
* Incomplete healing from prior cancer or other major surgery

Primary outcomes:
measure: Serum Prostate Specific Antigen
timeFrame: Monthly
Secondary outcomes:
measure: Duration of PSA decline
timeFrame: Monthly
measure: Safety variables
timeFrame: Monthly
measure: Time to Progression
timeFrame: Every 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06136156: Video Vitals and Biomarkers
Official title: Measuring Vital Signs and Biomarkers From Mobile Device Videos
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiometabolic Diseases
Lead sponsor: Maiv Health Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults greater than 18 years old may participate in this research study

Brief summary: The investigators are doing this research to study the ability of mobile devices to measure vital signs and biomarkers from video as compared to standard-of-care clinical office tools.


Eligibility criteria: Inclusion Criteria:

* Must be able to stay in a seated position for 30 minutes
* Must be able to participate in a venous blood draw

Exclusion Criteria:

* Condition that prevents prolonged seated position
* Condition that restricts ability to provide venous blood sample

Primary outcomes:
measure: Heart rate in beats per minute
timeFrame: 2 minutes
measure: Blood pressure (systolic/diastolic) in millimeters of mercury (mmHg)
timeFrame: 2 minutes
measure: Respiration rate in breaths per minute
timeFrame: 2 minutes
measure: Oxygen saturation in SpO2 percentage
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Park
country: United States
facility: ARCpoint Labs of Cedar Park
state: Texas
Study officials:
affiliation: Maiv Health Inc.
name: Sandro Luna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04281056: Impact of Tooth Loss and Denture on Oral Senses and Food Preferences
Official title: Impact of Complete Tooth Loss and Denture on Oral Sensory Abilities and Food Preference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth-loss
Keywords: Teeth loss
edentulousness
denture
tast
trigeminal senses
oral sensory ability
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Tooth loss impacts taste abilities and food intake. Present study aims at pertaining the impact of teeth loss and the replacement by means of complete denture on taste and trigeminal abilities, and on food preferences, and taste appetence.

Detailed description: Two groups of participants will be included. Participants wearing complete denture for at least one year (n=20) and their matched controls for age, sex, tobacco, and saliva secretion (n=20). Their oral sensory abilities of participants will be assessed including taste (electrogustometric thresholds, chemical taste identification ability) and trigeminal quantitative sensory testing. Food preferences and selectivity (Maitre et al., 2014) and taste appetence (Deglaire et al., 2012) will also be assessed.

Eligibility criteria: Inclusion Criteria:

Study Group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. Controls:

controls Group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in Angle's Class I occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. Matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate.

Exclusion Criteria:

* Aged under 18 or over 80 Y,
* not consenting to participate
* suffering from dental
* periodontal or gum pain for the last month.

Primary outcomes:
measure: taste detection thresholds
timeFrame: up to 30 days
Secondary outcomes:
measure: Chemical taste identification ability
timeFrame: up to 30 days
measure: Quantitative sensory testing
timeFrame: up to 30 days
measure: Food preferences and selectivity
timeFrame: up to 30 days
measure: Taste appetence
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service odontologie Hôpital Rothschild
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Adeline Braud, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298956: Brain Substrates for Cardiovascular Stress Physiology
Official title: Brain Substrates for Cardiovascular Stress Physiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Reaction
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.

Detailed description: Physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. Disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. The aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.

Eligibility criteria: Inclusion Criteria:

18-30 years old

Exclusion Criteria:

History of a diagnosed chronic medical or neurological disorder Current pregnancy Current illness or infection (e.g., cold, flu) Any condition that would prohibit them from engaging in physical exercise

Primary outcomes:
measure: Oxygen consumption in response to acute psychological stress
timeFrame: Immediately following intervention (up to 60 minutes)
measure: Heart rate in response to acute psychological stress
timeFrame: Immediately following intervention (up to 60 minutes)
measure: Additional heart rate in response to acute psychological stress
timeFrame: Immediately following intervention (up to 60 minutes)
Secondary outcomes:
measure: Perceived stress
timeFrame: Immediately following intervention (up to 60 minutes)
Other outcomes:
Locations:
city: Waco
country: United States
facility: Annie T. Ginty
state: Texas
Study officials:
References:
Clinical trial NCT02461056: Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain
Official title: Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: ibuprofen
hydromorphone
drug interactions
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the co-administration with opioids. The investigators searched whether intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.

Detailed description: Ninety patients, undergoing breast surgery, were included in one of the three groups (Ibuprofen, Hydromorphone, Ibuprofen+Hydromorphone groups). Positive analgesic efficacy was defined as a numeric rating scale (NRS) ≤3 on a 0-10 NRS, 30 min after the drug administration. Drug was administered by the Dixon and Mood up-and-down method. Starting doses were ibuprofen 50 mg, hydromorphone 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125 mg. The maximum doses were ibuprofen 800 mg, hydromorphone 2 mg, or ibuprofen 400 mg + hydromorphone 1 mg. Combination index (CI) (additive: 0.9-1.1, synergism: \<0.9, antagonism: \>1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status І or ІІ who were able to communicate and understand the pain scales

Exclusion Criteria:

* any contraindication to the use of ibuprofen or hydromorphone
* a history of allergy or hypersensitivity
* a calculated creatinine clearance of \<75 mL/min
* the presence or history of asthma, bleeding tendency, coronary artery bypass graft (CABG) surgery, heart failure, peptic ulcer disease, inflammatory bowel disease or any other gastrointestinal disorder, and renal or hepatic disease
* pregnancy
* age younger than 18 yr
* intraoperative use of regional anesthesia
* intraoperative administration of analgesics other than remifentanil
* postoperative pain ≤3 on a NRS in the post-anesthesia care unit (PACU)

Primary outcomes:
measure: Pain scores on the numeric rating scale (NRS)
timeFrame: postoperative 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Hyun Joo Ahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: