louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04337307: Decontamination of Incubators in a NICU (Neonatal Intensive Care Unit)
Official title: Evaluation of Two Procedures of Incubator's Decontamination in a NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Worker Patient Transmission
Keywords: Bacterial colonization of incubators
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare workers of the NICU of the Hopital Femme Mere enfant (HFME), Hospices Civils de Lyon, that will be involved in the process of decontamination of the incubators during the study period.

Brief summary: Nosocomial infections are responsible for morbidity and mortality in hospitalized neonates. The environment of the neonates and especially the incubators can constitute the reservoir of pathogenic bacteria. That is why decontamination of incubators is a major step in the fight against nosocomial infections in NICUs.

The hypothesize is that the usual procedure of decontamination, based on antiseptic molecules, is not sufficient to eradicate all pathogenic bacteria from the incubators.

In this study the investigator's aim to assess the efficacy of the usual procedure of decontamination and to compare it with another procedure based on steam pulverization. Another objective will be to explore a possible contamination of the hands of the healthcare workers, that can be involved in the cycle of transmission of bacteria to neonates. Finally, clinical data about the neonates housed in the incubator will be retrieved from clinical reports, to identify the occurrence of sepsis and if so, to compare the bacteria involved in the sepsis and the bacteria present in the incubator.


Eligibility criteria: Inclusion Criteria:

* Healthcare workers involved in the decontamination process of incubators during the study period (period of sampling of incubators before and after decontamination)
* The two people involved in the sampling of incubators
* The patients (neonates) that will be housed in one incubator decontaminated and sampled during the study period

Exclusion Criteria:

* Refusal to participate for healthcare workers and people involved in the sampling
* Refusal to give access to the clinical data of his child for the parent of the patients included in the study-

Primary outcomes:
measure: Absence of bacterial contamination
timeFrame: Day 0 (just before the decontamination)
measure: Absence of bacterial contamination
timeFrame: Day 0 (just after the decontamination)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT02283307: Dual Energy CT Urography With Reduced Iodinated Contrast
Official title: Dual Energy CT Urography Using 50% Reduction in Iodinated Contrast: Feasibility, Image Quality, and Radiation Dose Reduction With Virtual Unenhanced Images.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to validate that Dual Energy CT (DECT) urography when performed with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better image quality and equal or better diagnostic capability compared to traditional Single Energy CT (SECT) performed with a standard contrast dose.

Detailed description: The investigators hypothesize that DECT urography performed with a 50% iodine dose reduction is equivalent to SECT urography performed with a full iodine dose for:

* Enhancement of the aorta, renal arteries, and renal veins
* Enhancement of the renal cortex
* Enhancement of the renal pelvis, ureters, and bladder
* Subjective evaluation of image quality
* Objective evaluation of image quality

In addition, the investigators hypothesize that DECT virtual non-contrast images using material suppression from the same low iodine CT exam results in equivalent diagnostic information compared to SECT true non-contrast images obtained in the same patient during the same exam. If the true non-contrast images could be replaced by the virtual non-contrast images without loss of information, there is potential for DECT to both significantly lower radiation dose as well as significantly decreasing iodine dose.

The investigators designed this research protocol to prospectively test these hypotheses in a population scanned with a 50% reduced iodine DECT urography protocol compared to a control population scanned with a standard iodine dose clinical SECT urography protocol.

Eligibility criteria: Inclusion Criteria:

* Age \>50
* Outpatient scheduled to have a CT urography at the site

Exclusion Criteria:

* Severe allergy to iodine containing contrast
* Pregnancy (which is very unlikely for those over 50)
* Body mass index (BMI) over 35 kg/m2
* Inability to provide informed consent
* Inpatient

Primary outcomes:
measure: Diagnostic ability determined by image quality (subjective and objective evaluation of vessel attenuation and depiction, image noise, image quality and information from virtual non-contrast
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT00116207: An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Official title: Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Autonomic Neuropathy
Keywords: Type 1 Diabetes
Oxidative Stress
Diabetic Complications
Neuropathy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2005-06-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* A1C \<9%
* Mild neuropathy
* Mild retinopathy
* Mild nephropathy

Exclusion Criteria:

* History of drug or alcohol dependence, heart disease, viral illness, liver disease, advanced kidney disease
* Pregnant or nursing
* Severely overweight

Primary outcomes:
measure: Global [11C]HED Retention Index (RI)
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Global Coronary Flow Reserve as a Measure of Endothelial Function
timeFrame: Baseline, 24 months
measure: Systemic Oxidative Stress
timeFrame: 24 months
measure: Inflammation
timeFrame: 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Eva L Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pop-Busui R, Stevens MJ, Raffel DM, White EA, Mehta M, Plunkett CD, Brown MB, Feldman EL. Effects of triple antioxidant therapy on measures of cardiovascular autonomic neuropathy and on myocardial blood flow in type 1 diabetes: a randomised controlled trial. Diabetologia. 2013 Aug;56(8):1835-44. doi: 10.1007/s00125-013-2942-9. Epub 2013 Jun 6.
Clinical trial NCT02460107: Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Official title: Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Neuralgia
Lead sponsor: Catholic University of Korea Saint Paul's Hospital
Sponsor class: OTHER
Collaborators: name: Medy-Tox
First posted: 2015-06-02
Enrollment: 9
Sex: ALL
Minimum age (years): 20
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 determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* • more than twenty years of age

  * patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.
  * persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
  * a pain score of 4 or more on the numeric rating scale

Exclusion Criteria:

* • neuropathic pain caused by confounding factors other than diabetic neuropathic pain

  * contraindicated for botulinum toxin type A
  * a change in pain medication one month prior to study enrollment
  * a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
  * person who received botulinum toxin type A within three months prior to study enrollment

Primary outcomes:
measure: Pain intensity using numeric rating scale
timeFrame: 4 weeks after intervention
Secondary outcomes:
measure: Pain intensity using numeric rating scale
timeFrame: 1, 8, 12, 24 weeks after intervention
measure: Quality of life using WHOQOL
timeFrame: 4,8,12 weeks after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT06754007: Rapid Optimisation of Performance Enhancement and Skill (ROPES)
Official title: The Effectiveness of Rapid Optimisation of Performance Enhancement and Skill (ROPES) as an Exercise Training Programme for Sedentary Health Care Staff
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Sedentary
healthcare workers
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Despite innate knowledge of the benefits of regular physical activity, healthcare workers are just as physically inactive as the general population. Physical activity interventions delivered at the workplace seem perfect to improve the health of this large population.

The aim of the study is to deliver an efficacious, minimal time impost training program targeted at optimising health benefit while overcoming time-related barriers to initial uptake of regular exercise.

Detailed description: To evaluate the effectiveness of a 4-week, easily accessible, time-optimised exercise program (ROPES - Rapid Optimisation of Performance Enhancement and Skill) for healthcare workers.

60 staff recruited from Singapore General Hospital (SGH) will be randomly assigned into 2 groups, CONTROL or ROPES group. The ratio to intervention and control group is at 1:1. The staff will be assigned to each group respectively.

Eligibility criteria: Inclusion Criteria:

* Age group: 21 - 70 years old
* All participants must be free of musculoskeletal, surgical and/or neurological injury in the past 6 months.
* Participants not engaged actively in regular exercise i.e. exercises less than once a week and at a duration less than 30 mins per session.
* Healthy with stable management of any existing diabetes, cholesterol and/or hypertension.
* They should have no issues with the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria:

* Participants under the age of 21 or over the age of 70
* Newly diagnosed diabetes/metabolic syndrome/high cholesterol or uncontrolled high BP \>160 mmHg and under medical supervision.
* Subjects with cardiovascular conditions and on beta-blockers.
* Subjects who are pregnant or with recent (\< 3 months) diagnosis of a medical condition, especially cardiac-related conditions.

Primary outcomes:
measure: Physical work capacity
timeFrame: From enrollment to the end of study at 8 weeks
Secondary outcomes:
measure: Muscular Strength
timeFrame: From enrollment to the end of study at 8 weeks
measure: BMI
timeFrame: From enrollment to the end of study at 8 weeks
measure: Body Fat
timeFrame: From enrollment to the end of study at 8 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT06780007: Weight Loss Effect of Akkermansia Muciniphila in Obese Patients
Official title: Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 28≤BMI≤35Kg/m2
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.


Eligibility criteria: Inclusion Criteria:

-

1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss

Exclusion Criteria:

1. Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
2. Oral antibiotics in the past 1 month prior to enrollment;
3. No use of probiotic prebiotic products before 3 weeks of intervention;
4. people without a fitness fat loss program or history of gastric surgery during the intervention period;
5. Patients with severe gastrointestinal diseases;
6. Those who are known to be allergic to synbiotics or similar products;
7. Patients with no self-awareness and those with mental abnormalities;
8. Have a history of organ transplantation or malignant tumor disease;
9. Concurrent use of other experimental drugs or in other clinical trials;
10. Have a history of alcohol, tobacco and other drug abuse;
11. Those who are expected to be unable to complete the magnetic resonance examination;
12. Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.

Primary outcomes:
measure: Change in Body Mass Index(BMI)
timeFrame: Day 0, week4, week8, week12.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01043107: Relationship Between Computer and Cancer
Official title: Study on the Relationship Between The Computer Radiation and The Recrudesce Rate of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of city of Guangdong province

Brief summary: Thyroid Cancer is one of the most common malignant carcinomas. The incidence of thyroid cancer has risen in the past years. The recrudesce rate is highly raised. Computer is widely used by people nowadays, is it a predisposing factor to the highly raised recrudesce rate? This research observed two random assigned groups, in which the patients were diagnosed by pathologic results. One group were strictly prohibit with using computer, the other were not told. Finally collect the recrudesce rate of each group, analyze the data by statistic software.


Eligibility criteria: Inclusion Criteria:

* Thyroid cancer

Exclusion Criteria:

* Non-Thyroid cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00953407: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
* Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
* Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
* Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of corneal refractive surgery.
* Cylinder correction greater than 1.00 D.
* Current monovision contact lens wearers.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Lens Awareness
timeFrame: 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02328807: Focal Prostate Radio-Frequency Ablation
Official title: Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma
prostate
ENCAGE™
focal bipolar radiofrequency ablation
radiofrequency ablation (RFA)
radiotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Trod Medical N.V.
First posted: 2014-12-31
Enrollment: 6
Sex: MALE
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 main purpose of this study is to evaluate the safety and efficacy of focal (targeted) Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men 18 years of age or older
* Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
* No prior treatment for prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
* Prostate Cancer Clinical Stage T2a and below
* PSA \<10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy)
* Prostate size \<60 cc on transrectal ultrasound
* Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral).

Exclusion Criteria:

* Men less than 18 years of age
* Medically unfit for anesthesia
* Histology other than adenocarcinoma
* Biopsy does not meet inclusion criteria
* Men who have received any hormonal manipulation (antiandrogens; Luteinizing Hormone Releasing Hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months

Primary outcomes:
measure: Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: Up to 9 months
measure: Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Julio Pow-Sang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02908607: Thermal Imaging for Evaluation of the Cervix
Official title: Thermal Imaging for Cervical Cancer Screening and Early Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cervical Neoplasia
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.

Thus, a technology that improves the accuracy of the colposcopic exam is needed.

This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Women with premalignant cervical lesions who are candidates for conization (group A)
* Women with a normal cervix who are candidates for hysterectomy (group B)
* Women with newly diagnosed cervical cancer

Exclusion Criteria:

* For group A and B - women that had conization in the past

Primary outcomes:
measure: The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Meir medical center
Study officials:
References: