louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05308316: Sugars in Cigarettes
Official title: Impact of Sugars on Tobacco Product Toxicity and Abuse Liability
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate a comprehensive set of abuse liability and appeal measures, smoking intensity, as well as analyze the impact of sugar content on the formation in the oral cavity of smokers of DNA adducts derived from aldehydes and oxidative stress.


Eligibility criteria: Inclusion Criteria:

* Male or female age 21 years or older
* Smoking cigarettes that have been evaluated to have medium levels of sugar content
* No quit attempts in the past month nor intentions to quit smoking in the next month
* Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
* Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
* Stable vitals sign measurements (systolic BP ≤ 160 and \>90 mmHg, diastolic BP ≤ 100 and \>50 mmHg and heart rate ≤105 and \> 45 bpm) as determined by the licensed medical professional
* Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
* Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
* Women who are pregnant or nursing or planning to become pregnant.

Primary outcomes:
measure: To evaluate the impact of sugar content on behavioral measures
timeFrame: End of Intervention (2-3 Weeks from enrollment)
measure: To evaluate the impact of sugar content on smoking intensity
timeFrame: End of Intervention (2-3 Weeks from enrollment)
measure: To evaluate the impact of sugar content on subjective responses to cigarettes (e.g., reinforcing and sensory effects)
timeFrame: End of Intervention (2-3 Weeks from enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota, Division of Environmental Health Sciences
name: Irina Stepanov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Masonic Cancer Center Tobacco Research Programs
name: Dorothy Hatsukami
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198716: Xience or Vision Stent Management of Angina in the Elderly
Official title: Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Elderly
Angina
Lead sponsor: Brighton and Sussex University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2014-07-24
Enrollment: 800
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.


Eligibility criteria: Inclusion Criteria:

* AGE\>80
* Stable angina or acute coronary syndrome
* Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
* Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
* Any left main stem lesion

Exclusion Criteria:

* Acute ST segment elevation myocardial infarction
* Cardiogenic shock
* Platelet count =50 x 109/mm3
* Patient life expectancy \< 1 year
* Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
* Recent major GI haemorrhage (within 3 months)
* Any previous cerebral bleeding episode
* Participation in another investigational drug or device study
* Patient unable to give consent
* Clinical decision precluding the use of drug eluting stent

Primary outcomes:
measure: Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
timeFrame: 1 year
Secondary outcomes:
measure: Angina status
timeFrame: 1 year
measure: Antianginal medication
timeFrame: 1 year
measure: Procedural success
timeFrame: 1 Year
measure: MACE (major adverse cardiovascular events)
timeFrame: 1 year
measure: In-hospital complications
timeFrame: 1 Year
measure: Procedural cost
timeFrame: 1 Year
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Cardiac Research Unit
state: Sussex
Study officials:
References:
Clinical trial NCT02582216: 3D Augmented Reality Mirror Visual Feedback Applied to the Treatment of Unilateral Upper Extremity Neuropathic Pain.
Official title: 3D Augmented Reality Mirror Visual Feedback Therapy Applied to the Treatment of Persistent, Unilateral Upper Extremity Neuropathic Pain: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neuralgia
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 22
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: This study has two objectives. First, to introduce a new virtual reality method that incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D) augmented virtual reality system. Second, to evaluate the efficiency of this new method on a convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP, plexopathy, stroke) who were not responding adequately to both pharmaceutical management and traditional mirror therapy.

Detailed description: Each patient receives 5 treatment periods over a total period of 1 week, where each treatment period lasts a total of 20 minutes.

Eligibility criteria: Inclusion Criteria:

* Neuropathic pain in the unilateral upper extremity scored by DN4 questionnaire
* At least 3 months symptom duration following injury
* Minimum pain of 40 on a visual analogue scale (VAS);
* A drug treatment regimen that was stable for at least 2 weeks.
* Subjects were allowed to participate if they presented with any of the following: (1) A CRPS diagnosis, in accordance with the International Association for the Study of Pain criteria, Phantom Limb Pain (PLP), or spinal cord injury or plexopathy; and (2) an history of being treated before by conventional mirror therapy but, in their case, the mirror therapy failed.

Exclusion Criteria:

* Bilateral injury,
* Patients with epilepsy
* Side effects known to 3D (such as nausea, cephalalgia)
* Cognitive disorder
* Poor knowledge of the French language.

Primary outcomes:
measure: Pain on the Visual Analog Scale (VAS)
timeFrame: baseline and week
Secondary outcomes:
measure: Neuropathic Pain Assessed With DN4 Questionnaire
timeFrame: 1 week
Other outcomes:
measure: Questionnaire de Saint-Antoine
timeFrame: 1 week
Locations:
Study officials:
References:
Clinical trial NCT05802316: Awake Tracheal Intubation in Critical Care Patients
Official title: Awake Tracheal Intubation is Associated With Fewer Adverse Events in Critical Care Patients Than Standard Tracheal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Videolaryngoscopy
Intensive Care Unit Syndrome
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critical care patients requiring tracheal intubation

Brief summary: Tracheal intubation in critical care is a high-risk procedure requiring significant expertise and airway strategy modifications, such as awake intubation with video laryngoscope or flexible endoscope intubation. Furthermore, delayed sequence intubation can be used by experts in certain high-risk subgroups. The investigators hypothesise that awake tracheal intubation is associated with a lower incidence of severe adverse events than standard tracheal intubation in critical care patients.

Detailed description: Intubation records from 2020 to 2022 were acquired to examine all tracheal intubations of critical care patients at a tertiary hospital. Each awake tracheal intubation (awake) case - all of which were performed using a videolaryngoscope with a hyperangulated blade - was propensity matched with two controls (1:2 ratio; standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) undergoing general anaesthesia), with similar comorbidities and intubations performed after the induction of anaesthesia (asleep).

Eligibility criteria: Inclusion Criteria:

* Data for all critical care patients requiring tracheal intubation during the study period

Exclusion Criteria:

* included incomplete data reports

Primary outcomes:
measure: Hypotension
timeFrame: during intubation procedure (within 30 Minutes)
measure: cardiac arrest
timeFrame: during intubation procedure (within 30 Minutes)
measure: desaturation
timeFrame: during intubation procedure (within 30 Minutes)
Secondary outcomes:
measure: Cormack and Lehane classification (Class I-IV)
timeFrame: during intubation procedure (< 120 seconds)
measure: FPS
timeFrame: during intubation procedure (< 120 seconds)
measure: Airway Injury
timeFrame: during intubation procedure (< 120 seconds)
measure: other adverse events
timeFrame: during intubation procedure (< 120 seconds)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Centre Mainz
name: Marc Kriege
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05054816: Speech Locator In-car Performance Evaluation
Official title: Speech Locator In-car Performance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sonova Canada Inc.
First posted: 2021-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.


Eligibility criteria: Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N5 (severe) by 10 dB

Primary outcomes:
measure: Sound quality rating
timeFrame: Up to 6 hours over 3 2-hour sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Sonova Innovation Centre Toronto
state: Ontario
Study officials:
References:
Clinical trial NCT03450616: Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
Official title: Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will receive both treatment arms at the same time.
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.

Detailed description: This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.

The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.

The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.

Eligibility criteria: Inclusion Criteria:

* Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
* The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
* 18 years old or older
* Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.

Exclusion Criteria:

* • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).

  * Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
  * Patients with venous stasis ulcers greater than 17cm by 17cm.
  * Gross leg edema
  * Severe wound exudate
  * Patients with malignancy in the wound bed or margins of the wound
  * Previously confirmed and untreated osteomyelitis.
  * Patients with necrotic tissue with eschar present.
  * Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
  * Patients with wounds that requires surgical suction.

Primary outcomes:
measure: Rate of healing
timeFrame: Weekly for three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT02603016: Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Official title: Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Breast Neoplasms
Keywords: Clinical Nutrition
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Detailed description: GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.

Eligibility criteria: Inclusion Criteria:

* lung cancer and breast cancer patients confirmed by surgery pathology;
* ECOG physical stamina score of 0\~3 points;
* Expected lifetime \> 3 months;
* Need to receive radiation and chemotherapy;
* Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
* To follow-up, good adherence

Exclusion Criteria:

* Allergic to text drug;
* Pregnancy or lactation women;
* Suffering from mental illness of not easy to control,
* Have serious mental or cognitive dysfunction;
* Can not comply with the experimental scheme or can't cooperate with the follow-up;
* The patients who are unfavorable to the subject.

Primary outcomes:
measure: T-lymphocyte cell subsets
timeFrame: three mouths
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Shunchang Jiao, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06620016: Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.
Official title: Diagnostic Role of Circulating microRNAs in Small Testicular Masses Suitable for Testis Sparing Surgery and Post-chemotherapy Residual Masses Suitable for Retroperitoneal Lymph Node Dissection.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 60
Sex: MALE
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: All males \>= 18 yo with small testicular mass suitable for testis sparing surgery or post-chemotherapy germ cell residual mass suitable for retroperitoneal lymph node dissection.

Brief summary: The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively.


Eligibility criteria: COHORT A:

Inclusion Criteria:

* Age \>= 18 years
* Single testicular lesion, with \< 2 cm diameter and \< 30 % testicular volume involvement;
* Negative Serum Tumour Markers;
* Suitable for testis sparing surgery;
* Informed consent.

Exclusion Criteria:

* None

COHORT B:

Inclusion Criteria:

* Age \>= 18 years
* Single/multiple post-chemotherapy retroperitoneal lymph node lesion, with \> 1 cm (non seminomatous) / \> 3 cm (seminomatous) diameter in patients with previous testicular germ cell primary tumour;
* Negative Serum Tumour Markers;
* Suitable for retroperitoneal lymph node dissection;
* Informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: MicroRNA's germ cell cancer detection (Cohort A)
timeFrame: Baseline.
measure: MicroRNA's germ cell cancer detection (Cohort B)
timeFrame: Baseline.
Secondary outcomes:
measure: MicroRNA's germ cell cancer subtype detection (Cohort A + B)
timeFrame: Baseline.
measure: MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A)
timeFrame: Baseline.
measure: MicroRNA's disease recurrence/persistence detection (Cohort A + B)
timeFrame: Week 4.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola
Study officials:
References:
Clinical trial NCT02567916: A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol
Official title: A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Complication of Injection
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 129
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.


Eligibility criteria: Inclusion Criteria:

* age \>15 yrs
* ASA (American Society of Anesthesiologists risk class III-IV)I-II
* patients undergoing to gastroscopy

Exclusion Criteria:

* significant systemic disease (American Society of Anesthesiologists risk class III-IV)
* history of allergic reactions to any of the study drugs
* chronic use of opioid analgesics
* psychiatric disorder
* arrythmia
* pregnancy
* age \<18 yrs

Primary outcomes:
measure: Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).
timeFrame: 2 hours
Secondary outcomes:
measure: Patient Satisfaction With Sedation Including the Recall of Pain.
timeFrame: 2 hours and 5-7days after the end of the procedure
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Eun Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozawa A, Isono M, Ueno T, Kosaka Y, Nakano T, Inamura M, Kanai A, Okamoto H, Hoka S, Nomiyama S. [Comparison of propofol LCT and propofol MCT/LCT regarding the injection pain at different sites and the memory]. Masui. 2005 Nov;54(11):1241-6. Japanese.