louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02910726: A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers
Official title: Non-inferiority Study of Intra-operative Indocyanine Green Fluorescent Dye Versus Technetium Lymphoscintigraphy for Sentinel Lymph Node Biopsy in Pediatric Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pediatric Patients With Solid Tumors
Keywords: indocyanine green fluorescent dye
Technetium lymphoscintigraphy
sentinel lymph node biopsy
16-1003
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 6
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).


Eligibility criteria: Inclusion Criteria:

* Patients \<30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
* Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
* Patients who are cleared for surgery

Exclusion Criteria:

* History of reaction to ICG, iodides, or technetium radiocolloid
* Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
* Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
* Patients unwilling or unable to sign informed consent
* Women who are pregnant or breast-feeding

Primary outcomes:
measure: % of Patients in Whom a Sentinel Lymph Node is Identified
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Memphis
country: United States
facility: St. Jude's Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Todd Heaton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601426: NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study
Official title: NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 236
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. And then formulate a standard operating procedure for cold snare removal of polyps.


Eligibility criteria: Inclusion Criteria:

① Outpatient or inpatient patients aged 18-85 years old;

② Untamed, subpodial, and flat polyps with a diameter of 5-9mm (Paris classification: O-Is O-Isp、O-IIa；JNET Classification: Typel, Type2A);

③ Patients who agree to participate in this study.

Exclusion Criteria:

* Individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (PT prolongation greater than 3 seconds);

  * Polyp diameter\<5mm or ≥ 10mm, morphology does not conform or JNET classification ≥ Type 2B;

    * Individuals with severe heart, lung, liver and kidney dysfunction or severe mental disorders who cannot cooperate with the examination; ④ Patients with intestinal obstruction, inflammatory bowel disease, Lynch syndrome, and familial adenomatous polyposis diagnosis;

      * Pregnancy; ⑥ Those who fail to meet the requirements for bowel cleansing preparation (BBPS\<6 points).

Primary outcomes:
measure: Histopathological complete resection rate
timeFrame: 2-3 days
Secondary outcomes:
measure: Complete recovery rate of polyps
timeFrame: 2-3 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Xinyong Jia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05567926: Acute Effects of Beetroot Juice on Isometric Knee Extension Strength, Explosive Strength and Local Muscular Endurance
Official title: Acute Effects of Beetroot Juice Ingestion on Isometric Knee Extension Strength, Explosive Strength and Local Muscular Endurance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: isometric strength
beetroot
nitrates
local muscle endurance
supplementation
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a double-blind placebo-controlled cross-over trial that aims to determine the acute effect of beetroot juice ingestion on isometric knee extension strength, explosive strength and local muscular endurance.

Detailed description: The study aims to determine whether concentrated beetroot juice has an acute effect on isometric strength of the knee muscles and the rate of force development in knee extension, as well as endurance of the same muscle. This will be a cross-over study. 20 subjects will be randomly selected to the experimental group or control group; after 1 week, participants will repeat the measurements in the other condition. Subjects will consume 140 ml of beetroot juice extract 2.5 hours before the measurement or placebo (140 ml of blackcurrant juice with added appropriate amount of sugar to equalize the carbohydrate value and lemon juice fort the taste). An isometric dynamometer will be used to measure the isometric strength of the knee extensors. Investigators will quantify peak force, rate of force development, endurance of knee extensors at 50 % of the maximal force, and the force recovery after a fatiguing protocol.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30 years
* Physically active and healthy athletes (recreational or professional)

Exclusion Criteria:

* Cardiovascular, pulmonary, metabolic, neurological diseases and musculoskeletal injuries
* Smokers
* Consumption of drugs such as antacids and proton pump inhibitors in the previous 3 months
* Pregnant or breastfeeding women
* Beetroot allergic participants

Primary outcomes:
measure: Knee extension strength
timeFrame: 2 hours after the ingestion of beetroot juice or placebo
Secondary outcomes:
measure: Knee extension explosive strength
timeFrame: 2 hours after the ingestion of beetroot juice or placebo
measure: Knee extension local muscle endurance
timeFrame: 2 hours after the ingestion of beetroot juice or placebo
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT03780426: tSMS in Essential Tremor
Official title: Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Tremor
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.


Eligibility criteria: Inclusion Criteria:

* Essential tremor

Exclusion Criteria:

* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
* other main neuropsychiatric co-morbidity
* pregnancy

Primary outcomes:
measure: Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.
timeFrame: Immediately after treatment compared baseline
Secondary outcomes:
measure: Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
timeFrame: 15 minutes after treatment compared to baseline
measure: Change from baseline in rest tremor amplitude, as measured by accelerometry.
timeFrame: Immediately after treatment and 15 minutes after treatment compared baseline.
measure: Change from baseline in tremor frequency, as measured by accelerometry.
timeFrame: Immediately after treatment and 15 minutes after treatment compared baseline.
measure: Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)
timeFrame: 5 minutes after treatment and 20 minutes after treatment compared to baseline
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: CINAC, Hospital Universitario Puerta del Sur
state: Madrid
Study officials:
References:
citation: Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1.
citation: Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11.
citation: Dileone M, Mordillo-Mateos L, Oliviero A, Foffani G. Long-lasting effects of transcranial static magnetic field stimulation on motor cortex excitability. Brain Stimul. 2018 Jul-Aug;11(4):676-688. doi: 10.1016/j.brs.2018.02.005. Epub 2018 Feb 7.
Clinical trial NCT06115226: Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia
Official title: Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Duodenal Atresia
Keywords: Congenital duodenal atresia
Neonatal obstruction
Laparascopic
Laparotomy
Neonatal duodenal atresia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 70
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject having undergone neonatal surgery for congenital duodenal atresia or stenosis in the different participating centers between January 2009 and December 2019

Brief summary: Congenital duodenal atresia is a common cause of neonatal obstruction affecting 1 in 5000-10000 neonates. Laparoscopic management of this malformation is becoming increasingly common. However, few comparative studies exist and are often monocentric including few patients. This study will be multicentric, international and comparative to determine the place of laparoscopic surgery in the management of congenital duodenal atresia.


Eligibility criteria: Inclusion criteria:

* Minor subject
* Subject having undergone neonatal surgery for congenital duodenal atresia or stenosis in the different participating centers between January 2009 and December 2019
* Subject (and/or his/her parental authority) who has not expressed, after information, his/her opposition to the reuse of his/her data for the purpose of this research

Criteria for non-inclusion:

* Subject (and/or his/her parental authority) who has indicated, after information, his/her opposition to the re-use of his/her data for the purposes of this research
* Conversion linked to a renunciation of the surgeon, procedure not started (optical introduction, unfeasibility by the surgeon due to lack of experience or technical impossibility)

Primary outcomes:
measure: rate of complications
timeFrame: 3 months after laparoscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06318026: Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment
Official title: Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Unhealthy Alcohol Use
Keywords: Patient-centered care
Shared decision-making
Population-based management
Quality improvement
Decision aid
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Washington
First posted: 2024-03-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions in Kaiser Permanente Washington to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 25 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.


Eligibility criteria: Inclusion Criteria:

1. Adult primary care patients ≥18 years old on the day of a primary care appointment; and
2. ≥4 symptoms on the Alcohol Symptom Checklist, or 2-3 symptoms on the Alcohol Symptom Checklist with at least one symptom associated with high risk of progression to severe symptoms, documented in the electronic health record associated with the primary care appointment; and
3. high-risk drinking on the alcohol screening questionnaire (AUDIT-C ≥7) on the day of the Alcohol Symptom Checklist or in the prior 30 days documented in the electronic health record.

Exclusion Criteria:

1. Documented request to not participate in research, or
2. Patient was eligible for the Vanguard pilot study.

Primary outcomes:
measure: Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims).
timeFrame: Treatment initiated up to 12 months.
measure: Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire.
timeFrame: Up to 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Katharine Bradley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Gwen Lapham, PhD, MPH, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746326: Treatment in Right Colon Diverticulitis Patients
Official title: Operative and Conservative Treatment in Right Colon Diverticulitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcome
Keywords: diverticulum
surgery
appendicitis
sigmoid volvulus
caecum
diverticulitis
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conservative treatment, Operative treatment
Primary purpose: TREATMENT

Brief summary: The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy.

Detailed description: The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Here, we aimed to discuss the results of conservative and surgical treatment for right colon diverticulitis in the light of the literature. 150 patients treated for colon diverticulitis between 2015-2020 were retrospectively screened. Right colon diverticulitis detected incidentally, missing data, and left colon diverticulitis were excluded from the study. Data of a total of 26 patients were accessed. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy

Eligibility criteria: Inclusion Criteria:

* diagnosed with right colon diverticulitis

Exclusion Criteria:

* Left colon diverticulitis
* Right colon diverticulitis detected incidentally
* lacking data

Primary outcomes:
measure: Number of Participants with mortality
timeFrame: up to 24 weeks
measure: Number of Participants with wound infection
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Training and Research Hospital
Study officials:
References:
Clinical trial NCT03902626: Chronic Pain Attitudes Medical and Physiotherapy Students
Official title: Understanding Attitudes and Beliefs of Undergraduate Medical and Physiotherapy Students - a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: attitudes
chronic low back pain
functionality
healthcare professional students
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: Glasgow Caledonian University
name: University of Glasgow
First posted: 2019-04-04
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students registered for the 2009 physiotherapy and medical degree at two Scottish universities

Brief summary: This is an analysis of data collected from 2009-2014 from medical students at GCU and physiotherapy students at UoG measuring attitudes towards patients with chronic low back pain and their functionality.

Detailed description: This is longitudinal study with the data collected from 2009-2014 from medical students and physiotherapy students at two different Scottish universities measuring attitudes towards patients with chronic low back pain and their functionality. The outcome measure used was HC-PAIRS the original 15 point Likert Scale. Data was analysed using SPSS (version 25). All data was found to be normally distributed. Descriptive statistics were presented as mean (Standard Deviation). Inferential statistics were carried out using a two-way ANOVA with year of study and discipline of degree as independent variables with post hoc analysis. A p-value of \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

-Engaged in the 2009 physiotherapy degree at Two Scottish universities

Exclusion Criteria:

-Anyone who is not on the above degree courses.

Primary outcomes:
measure: HC-PAIRS (Health care providers pain and impairment relationship scale)
timeFrame: 1 x year for duration of degree course at start of first semester
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01984957: Differential Study of Muscle Transcriptome
Official title: Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS
SMA
SBMA
Keywords: ALS
Motor neuron diseases
Transcriptome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2013-11-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To isolate biomarkers of ALS in muscle

Detailed description: At present, there is no validated biological diagnostic marker for amyotrophic lateral sclerosis (ALS). The main objective of the study is to isolate a set of genes that are specifically dysregulated in muscle from ALS patients.

Gene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)

Eligibility criteria: Inclusion criteria :

- Patient with ALS, SMA, or SBMA

Exclusion criteria :

* Indication against biopsy (allergy to anesthetics local haemostasis disorders)
* Treatments that can affect muscle metabolism

Primary outcomes:
measure: Gene expression levels
timeFrame: day 1
Secondary outcomes:
measure: muscle denervation
timeFrame: day 1
measure: Functional evaluation
timeFrame: day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'évaluation Thérapeutique, Dr LACOMBLEZ
Study officials:
affiliation: APHP
name: Pierre-Francois Pradat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: