louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01533311: Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study
Official title: Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonpolypoid Colorectal Neoplasms(NP-CRN)
Keywords: nonpolypoid colorectal neoplasms(NP-CRN)
prevalence
histology
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 1342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive adult patients undergo colonoscopy by one endoscopist from Jan 2009 to Dec 2010

Brief summary: The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer than flat and polypoid lesions.


Eligibility criteria: Inclusion Criteria:

* consecutive adult patients undergo colonoscopy by one endoscopist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03983811: Adjuvant Chemotherapy With or Without Intercalated Icotinib
Official title: Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients With or Without Intercalated Icotinib Therapy: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 174
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: Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study aims to assess the efficacy and safety of adjuvant chemotherapy with or without Intercalated combination of icotinib in patients undergoing resection of stage IIB to IIIA (N1-2) EGFR-mutated NSCLC.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging IIB to ⅢA, N1-2; PS = 0 or 1; Adequate hematological, biochemical and organ functions

Exclusion Criteria:

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

Primary outcomes:
measure: Disease free survival
timeFrame: From the date of surgery until the date of first confirmed disease relapse or metastasis, whichever came first, assessed up to 5 years
Secondary outcomes:
measure: Number of Participants with Adverse Effects
timeFrame: Duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06674811: Biomarkers of Resiliency in Childhood Cancer Surgery
Official title: Digital Biomarker and Omics-Based Assessment of Surgical Resiliency in Children Undergoing Solid Tumor Resection: a Pilot Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cancer
Neuroblastoma
Sarcoma
Wilms Tumor and Other Childhood Kidney Tumors
Childhood Soft Tissue Sarcoma
Keywords: digital biomarker
remote monitoring
smartwatch
surgery
pediatric cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults 3-18 years old who are undergoing surgical resection for an extracranial solid tumor and their primary caregiver or guardian.

Brief summary: This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are:

1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery?
2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery?

Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to:

* wear a smartwatch
* complete questionnaires
* allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes

These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.


Eligibility criteria: Inclusion Criteria:

* 3-18 years old at enrollment
* With solid tumors of the chest, abdomen, and extremities including neuroblastic tumors, sarcoma including soft tissue and bone, kidney tumors, liver tumors, ovarian tumors, lung and pleural-based tumors, and intestinal tumors

-OR-

* Guardian or primary caregiver of patient 3-18 years old with one of the aforementioned tumors.

Exclusion Criteria:

* Patients who are known to be pregnant or prisoners.

Primary outcomes:
measure: Surgical resilience
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life - PedsQL
timeFrame: 1 year
measure: Quality of life - PHQ-9
timeFrame: 1 year
measure: Biomarkers
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephanie Polites, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01935011: DBS Frequency on Swallowing Function in Parkinson's Disease
Official title: Effects of the Stimulation Frequency of STN DBS on Swallowing Function in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.

Brief summary: The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.

Detailed description: This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.

The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary

Eligibility criteria: Inclusion Criteria:

* Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria

Primary outcomes:
measure: The primary outcome would be the OPMS swallowing function scores
timeFrame: One year
Secondary outcomes:
measure: The secondary outcome would be the swallowing questionnaire score
timeFrame: One year
measure: The secondary outcome would also be the unified PD rating scale
timeFrame: One year
measure: The secondary outcome would be the FOG questionnaire score
timeFrame: One year
measure: The secondary outcome would be the standing-walking-sitting test score
timeFrame: One year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Tao Xie, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512611: Photoplethysmography for Diagnose Incipient Hypovolemia
Official title: Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Keywords: Photoplethysmography
Vital signs
Hemodynamics
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy blood donor volunteers.

Brief summary: Hypovolemia caused by acute bleeding increased morbi-mortality in emergency and operatin rooms. Precise real-time diagnosis of incipient acute hypovolemia is lacking at the bedside. We hypothesize that the infrared-red signals of pulse oximetry are sensitive to acute changes in patient's volemia. We aimed to test this hypothesis in a cohort of healthy blood donors as a model of simulated acute hypovolemia.

Detailed description: This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform can detect incipient hypovolemia. The investigators will studied 60 blood donor volunteers as a model of slight hypovolemia (8-10% of the volemia). Vital signs and photoplethysmography will be recorded in the thumb of the tested hand during a standard blood donation protocol. Recorded data will be analyzed and compared before and after blood donation .

Eligibility criteria: Inclusion Criteria:

* Written Inform Consent
* weight \> 50 kg,
* hemoglobin \>12.5 gr/dl

Exclusion Criteria:

* pregnancy,
* ≤ 12 months from delivery or abortion,
* symptoms of allergy,
* fever \>37 °C,
* infectious diseases,
* addictions,
* volunteers that received previous blood transfusions

Primary outcomes:
measure: Analysis of the continuous component (DC) of the photoplethysmography signal.
timeFrame: 15 minutes
Secondary outcomes:
measure: Analysis of non-invasive arterial blood pressure (NIBP)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad
name: Gerardo Tusman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00358111: Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
Official title: A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dysplasia
Cancer
Keywords: high-grade disease
Cervical examination
targeting biopsies
dysplasia
cancer
Lead sponsor: SpectraScience
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2006-07-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.


Eligibility criteria: Inclusion Criteria:

* Documented abnormal pap test

Primary outcomes:
measure: Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.
timeFrame: ongoing - estimated at 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Women's Interventional Health
state: California
city: Iowa City
country: United States
facility: U of Iowa Health Center
state: Iowa
Study officials:
affiliation: SpectraScience
name: Jim Hitchin
role: STUDY_CHAIR
References:
Clinical trial NCT05372211: Survey on the Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants
Official title: Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants: a National Survey in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erythropoietin; Infant; Surveys and Questionnaires
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China

Brief summary: Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) and extremly low birth weight (ELBW) infants and has been licensed for this indication in Europe in 1997. The objective of the study was to obtain information on the use or nonuse of rhEPO in neonatal units in China.

Detailed description: The survey was developed by a team of neonatologists at Shenzhen People's hospital . The survey consisted of 26 questions covering three areas: the characteristics of the survey respondents, the use of rhEPO in VLBW and ELBW infants , and other related questions. The questionnaire was presented in the Questionnaire Star format (https://www.wjx.cn/, Hangzhou Oway Medical Technology,Changsha, China). we plan to conduct a cross-sectional survey through the Neonatal Professional Committee of the Chinese Medical Doctor Association WeChat platform. The questionnaire is going to be distributed to nearly 500 representative neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across the country. Furthermore, this study was approved by the ethics committee of the Shenzhen People's Hospital.

Eligibility criteria: Inclusion Criteria:

neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China

Exclusion Criteria:

neonatologists and pediatricians from same hospitals

Primary outcomes:
measure: The survey (the clinical use of rhEPO)
timeFrame: 01-june-2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06786611: Quantitative Assessment of Lumbar Facet Joint Degeneration, A Retrospective Study.
Official title: Enhanced Quantitative Assessment of Lumbar Facet Joint Degeneration: Refining the Weishaupt Grading System With Grayscale Curve Fitting and Imaging Parameter.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facet Joint Pain; Low Back Pain
Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence
Facet Joint Disease
Keywords: facet joint degeneration
low back pain
Weishaupt grading system
Grayscale curve fitting
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent imaging examination in Shanghai Changzheng Hospital from September 2020 to July 2024 to evaluate lumbar joint degeneration were included.

Brief summary: Observational study

The purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the Weishaupt grading system by using gray-scale curve fitting and imaging parameters.

The main questions it aims to answer are: How to realize quantitative analysis of lumbar facet joint degeneration in patients with chronic low back pain with MRI?

The MRI information of patients with different grades of articular process joint degeneration has been statistically summarized in nearly 5 years


Eligibility criteria: Inclusion Criteria:

* (1) Age range from 20 to 80 years old; (2) Persisted chronic low back pain (CLBP) more than 12 weeks; (3) Complete preoperative X-ray and 1.5T MRI examination.

Exclusion Criteria:

* (1) Scoliosis, Cobb angle\>20°; (2) Lack of preoperative X-ray or MRI examination; (3) 3.0T MRI; (4) The interval between preoperative X-ray and MRI examinations is more than one month; (5) Previous lumbar spine internal fixation surgery; (6) Lumbar spondylolisthesis \> 5 mm, with severe dislocation of facet joints; (7) Intravertebral bone cement implantation; (8) Severe spinal joint disease (e.g. mandatory spondylitis); (9) Spinal tumors; (10) The maximum extension depth of Modic changes (MC) relative to vertebral body height was greater than 25%.

Primary outcomes:
measure: Grayscale Curve Fitting
timeFrame: "From enrollment to the end of treatment at 1 weeks
Secondary outcomes:
measure: Correlation analysis and logistic regression analysis between imaging parameters
timeFrame: "From enrollment to the end of treatment at 1 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital, Second Military Medical University
state: Shanghai
Study officials:
References:
Clinical trial NCT02192411: Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial
Official title: Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; a Double Blinded, Randomized, Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration
Keywords: lidocaine
tumescent
endovenous
laser
pain
Lead sponsor: Midwest Vein Center
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe and effective treatment for varicose veins. Essential to the successful ablation of refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can be used safely as long as serum concentrations remain low, its use carries the risk of lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to use the minimum effective concentration of lidocaine needed to manage pain during a procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent anesthesia will function as well as the standard dose for pain management in endovenous laser treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort throughout the procedure. This will be achieved through a direct comparison of intra- and post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine concentration or the standard lidocaine concentration.


Eligibility criteria: Inclusion Criteria:

* Large Saphenous Vein treatment
* 16-85 years old, good health
* Able to understand informed consent
* Eligible for EVLT determined by physician

Exclusion Criteria:

* Patients with know lidocaine sensitivity
* Bleeding disorders
* Pregnancy
* Congestive heart failure
* Liver dysfunction
* Patient ineligible for EVLT

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Midwest Vein Center
state: Illinois
Study officials:
References:
Clinical trial NCT01924611: Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination
Official title: Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Atraumatic Restorative Technique
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: Academic Centre for Dentistry in Amsterdam
First posted: 2013-08-16
Enrollment: 232
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Detailed description: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Eligibility criteria: Inclusion Criteria:

* Children of both genders enrolled in school,
* Children aged between 6 and 7 years,
* having cavity with access to ART hand instruments,
* cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
* proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

Exclusion Criteria:

* Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
* Children out of the age range,

Primary outcomes:
measure: Number of teeth with fractured restorations.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Universidade Federal da Paraíba
state: Paraíba
Study officials:
affiliation: Academic Centre for Dentistry in Amsterdam
name: Evert van Amerongen, DDS, PhD, Professor
role: STUDY_DIRECTOR
affiliation: UFPB
name: Fabio Correia Sampaio, DDS PhD PostDoc
role: STUDY_DIRECTOR
References: