louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00628147: Clinical Evaluation of Narrow Band Imaging Colonoscope
Official title: Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Neoplasms
Keywords: colonic neoplasms
colonoscopy
narrow band imaging
diagnostic techniques
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2008-03-04
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

Detailed description: This is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. Though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. Research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. Advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. A new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). Initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. As such, we hypothesized that the use of NBI would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. We aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Eligibility criteria: Inclusion Criteria:

* referred for elective outpatient colonoscopy

Exclusion Criteria:

* known inflammatory bowel disease
* personal or family history of polyposis syndrome
* referral for resection of a known lesion

Primary outcomes:
measure: Neoplasm Miss Rate
timeFrame: same day
Secondary outcomes:
measure: Neoplasm Detection Rates
timeFrame: same day
measure: Completion of Examinations
timeFrame: same day
measure: Procedure Complications
timeFrame: procedure and post-procedure complications within 30 days after colonoscopy
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VAPaloAltoHCS
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Roy Soetikno, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
Clinical trial NCT04130347: Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
Official title: Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 499
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.

Brief summary: Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors.

Detailed description: Ethical approval was submitted and approved by the regional ethical committee, Etisk prövningsnämnd Uppsala, # 2017/418.

Patients were selected from the time span of april 2016 to september 2017. The investigators identified 499 patients that had undergone any of the selected procedures. The procedures were, pancreatic resection, HIPEC surgery in colorectal setting, gynecological debulking in metastasized ovarian cancer, and liver resection.

The risk of acute kidney injury (AKI) by the KDIGO definition during the postoperative period will be estimated in the group as a whole, and for each type of surgery separately. In addition the data will be stratified by sex to investigate systematic gender disparities or physiological differences. Length of stay, thirty day and sixty day mortality will secondary endpoints.

Eligibility criteria: Inclusion Criteria:

Any of the selected procedures.

Exclusion Criteria:

Patient has expressed his or her will to nor participate in any study.

Primary outcomes:
measure: Incidence of AKI
timeFrame: the first 24- 72 hours postop
Secondary outcomes:
measure: Mortality
timeFrame: 30, 60 and 360 days postoperatively
measure: Major Adverse Kidney Events
timeFrame: 30, 60 and 360 days postoperatively
measure: Fluid balance
timeFrame: 24-72h
measure: Electrolyte disturbances
timeFrame: 24-72h
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04065347: Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)
Official title: Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Adherence, Medication
Keywords: Adherence
Dried Blood Spots
Tenofovir-diphosphate
Antiretroviral therapy
Tenofovir alafenamide
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-08-22
Enrollment: 84
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: PLWH who are initiating/re-initiating or have been on TAF for \> 6 months.

Brief summary: This study is being done to evaluate the relationship between adherence to antiretroviral therapy (ART) and HIV drug concentrations in persons living with HIV (PLWH) that are taking tenofovir alafenamide (TAF). Adherence will be measured with an ingestible biosensor (digital pill). Antiretroviral drug concentrations will be measured in different types of blood cells.

Detailed description: PLWH taking or initiating/re-initiating TAF will be recruited for a 16-week study. Upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. Study participants already taking TAF will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. Participants initiating/re-initiating TAF will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

Eligibility criteria: Inclusion Criteria:

1. Females or males with HIV, able to give informed consent and comply with study procedures.
2. Currently on (\> 6 months), or planning to initiate/re-initiate TAF.

Exclusion Criteria:

1. For females of childbearing age, active pregnancy or any intent to become pregnant
2. Hepatitis C (HCV) infection for which treatment is anticipated within the next 16 weeks after enrollment. Treated HCV with sustained virologic response is allowable if last dose of HCV antivirals was \>12 months prior to enrollment
3. Advanced renal (eGFR \<30 mL/min/1.73m\*\*2) or liver (Child-Pugh B or C) disease
4. History of extensive bowel surgery, gastric bypass, or gastroparesis
5. Concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the PK of TAF (e.g. rifamycins, carbamazepine, phenytoin, St. John's Wort, tipranavir)

Primary outcomes:
measure: Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)
timeFrame: Week 12
measure: Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado-AMC
name: Peter L Anderson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834547: Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players
Official title: Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitively Healthy Subjects Influenced by Psychoactive Drugs
Keywords: chess, cognition
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess players in chess games and neuropsychiatric standardized tests. We hypothesize that substances will change cognitive performance in chess players leading to changed results in chess games and neuropsychiatric tests.


Eligibility criteria: Inclusion Criteria:

* male
* 18-60 years old
* existence of ELO-number

Exclusion Criteria:

* physical diseases (e.g. diabetes mellitus, etc.) with necessity of using prescription drugs
* psychiatric diseases (e.g. psychosis, bipolar disorders, etc.) with necessity of using prescription drugs
* addiction of psychoactive substances
* smoker or quitter (\< 5 years)
* use of more than 5 cups of coffee per day
* irregular day-night-rhythm (e.g. shift workers)

Primary outcomes:
measure: Chess games (win/ lose/ tie)
timeFrame: two years
Secondary outcomes:
measure: time period for decision of chess games
timeFrame: results of ches games
measure: Cognitive performance measured with standardized neuropsychiatric tests (Tower of Hanoi, Trail-Making test, Stroop-Test, Psycho-Motor-Vigilance test, Wisconsin-Card-Sorting-Test, Balloon Analog Risk Task)
timeFrame: outcome of tests
measure: measuring of risk taking behaviour, motivation, mood using standardized questionnaires
timeFrame: outcome of tests
measure: adverse events
timeFrame: type of adverse events
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Psychiatry and Psychotherapy
Study officials:
References:
Clinical trial NCT04745247: Stimulate the Face to Improve Tactile Acuity on the Hand
Official title: Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
RSS
Face
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.


Eligibility criteria: Inclusion Criteria:

* Age: 30-80 years old
* Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
* Stroke event dates at least 3 months before the date of inclusion to the study
* Mild-to-moderate sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
* Capacity to provide written consent
* Affiliation to a social security scheme

Non-Inclusion Criteria:

* Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
* Severe speech disorder, global aphasia and/or cognitive impairment
* Multiple stroke events
* Bilateral stroke event
* Hemineglect
* History of neurological or psychiatric illness
* Allergy to glue/tape
* Male participants refusing to shave their moustaches or beards during the study
* Other experimental procedure is forbidden during the weeks where the study is performed
* Pregnant, parturient and lactating women
* Persons deprived of their liberty
* Adult persons subject to a legal protection measure: guardianship, curatorship
* Congenital or acquired malformation/injury of the test finger

Exclusion Criteria:

* Impossibility to maintain hand position necessary for the tests due to severe spasticity
* Severe impairment of the sensibility of the face preventing the administration of the RSS
* Severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mN)

Primary outcomes:
measure: Tactile acuity : 2 point discrimination test
timeFrame: Week 3
measure: Tactile acuity : Absolute threshold detection test after 3h of RSS
timeFrame: Week 3
Secondary outcomes:
measure: Jebsen-Taylor hand function test (JTHFT)
timeFrame: Week 3
measure: Questionnaire comfort/ease to use
timeFrame: Week 3
Other outcomes:
Locations:
city: Saint-Genis-Laval
country: France
facility: Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
Study officials:
affiliation: Service de Médecine Physique et Réadaptation
name: Jacques LUAUTE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04145947: Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients
Official title: Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Triple Negative Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: triple negative breast cancer patients with age ≤ 60 years old

Brief summary: The relationship between immune inflammation-related protein complexes in blood of triple negative breast cancer patients and recurrence or metastasis of breast cancer will be studied.

Detailed description: 200 patients with triple negative breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female
* Postoperative pathology confirmed invasive breast cancer after surgery for breast lump
* Breast cancer-related chemotherapy and radiotherapy completed
* triple negative breast cancer patients
* age ≤ 60 years old

Exclusion Criteria:

* Male
* Aged above 60
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient

Primary outcomes:
measure: immune inflammation-related protein complexes
timeFrame: 2 years
measure: blood markers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xi Shen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818347: Hydrogen Gas for Cancer Rehabilitation
Official title: Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Solid Tumor
Keywords: Solid tumor
Hydrogen gas
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shanghai Asclepius Meditech Co., Ltd
First posted: 2019-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: the patients will inhale hydrogen and oxygen with oxyhydrogen generator
Primary purpose: TREATMENT

Brief summary: The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and prognosis of cancer patients.

Detailed description: By enrolling patients of multiple kinds of cancer adapted to enrolled criteria, this study will document for the first time the short and long term efficacy of hydrogen gas.The evaluation indexes include peripheral blood lymphocyte immunoassay, improvement of sleep, diet and exercise, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* Standard therapies have finished according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Improvement of sleep, diet and exercise
timeFrame: 3 months
measure: Improvement of immune function
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Fuda cancer institute
state: Guangdong
Study officials:
References:
citation: Chen JB, Kong XF, Qian W, Mu F, Lu TY, Lu YY, Xu KC. Two weeks of hydrogen inhalation can significantly reverse adaptive and innate immune system senescence patients with advanced non-small cell lung cancer: a self-controlled study. Med Gas Res. 2020 Oct-Dec;10(4):149-154. doi: 10.4103/2045-9912.304221.
citation: Chen JB, Kong XF, Mu F, Lu TY, Lu YY, Xu KC. Hydrogen therapy can be used to control tumor progression and alleviate the adverse events of medications in patients with advanced non-small cell lung cancer. Med Gas Res. 2020 Apr-Jun;10(2):75-80. doi: 10.4103/2045-9912.285560.
citation: Chen J, Kong X, Mu F, Lu T, Du D, Xu K. Hydrogen-oxygen therapy can alleviate radiotherapy-induced hearing loss in patients with nasopharyngeal cancer. Ann Palliat Med. 2019 Nov;8(5):746-751. doi: 10.21037/apm.2019.11.18.
Clinical trial NCT05839847: LIFU for Anxiety Management
Official title: Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will act as their own sham - sham vs real will be conducted in separate study visits. 2 arms exist for 2 variations of the NPU task.
Primary purpose: TREATMENT

Brief summary: This study is examining the effects of noninvasive brain stimulation on anxiety. Low-intensity focused ultrasound (LIFU) will be utilized to neuromodulate the brain prior to a task (NPU). Physiological recordings will be taken throughout (EEG, EMG, HR, BP, RR, GSR).

Detailed description: This study is a research project examining the effects of noninvasive brain stimulation on anxiety. This study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. Participants will undergo a functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, to image the bone and brain tissue. Participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Participants will undergo a threat task involving brief (100ms) shocks (1-5mA) and startle noises. Brain signals (EEG), muscle twitch (EMG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. Participants will be asked to complete behavioral questionnaires.

Eligibility criteria: Inclusion Criteria:

* High or low trait anxiety

Exclusion Criteria:

* claustrophobia
* Contraindications to MRI (implants)
* Contraindications to CT (pregnancy)
* Active medical disorder with CNS effects (e.g. Alzheimers)
* History of neurologic disorder (e.g. Parkinson's, epilepsy)
* History of head injury w/ LOC for \>10 min
* History of alcohol or drug dependence
* History of current cardiovascular disease

Primary outcomes:
measure: Change in EMG eye startle reflex
timeFrame: Through study completion, an average of 2 weeks
measure: Change in heart rate using ECG
timeFrame: Through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
References: