louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02244710: EndoTic - Endothelium and Ticagrelor
Official title: EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome (ACS)
Keywords: Circulating Endothelial Cells
Endothelial Progenitor Cells
Acute coronary syndrome (ACS)
Ticagrelor
Lead sponsor: Fundación Investigación Sanitaria en León
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2014-09-19
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).

Detailed description: ACS Patients in both treatment groups will be assessed:

Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected

Eligibility criteria: Inclusion Criteria:

* Willing to sign Informed Consent Form
* 18 yr or older
* Male and female (post menopause or contraception treatment)
* ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
* Planned invasive strategy (coronariography performed within 72hrs after admission)

Exclusion Criteria:

* Aspirin, clopidogrel or ticagrelor allergy.
* Hemorrhagic diathesis or very high risk of bleeding.
* Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
* Limited life expectancy.
* Elective surgery planned.
* High chance of not being able to complete the follow-up period.

Primary outcomes:
measure: Number of cells
timeFrame: Baseline
measure: Number of cells
timeFrame: 48 hours after last chest pain episode
measure: Number of cells
timeFrame: 1 month visit
Secondary outcomes:
measure: Platelet reactivity
timeFrame: At the time of coronary angiography
measure: Platelet reactivity
timeFrame: 1 month visit
Other outcomes:
measure: Safety: Bleeding and ischemic adverse events
timeFrame: 18 months (Study duration)
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago
state: La Coruña
city: Leon
country: Spain
facility: Hospital de Leon
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
Study officials:
affiliation: Fundación Investigación Sanitaria en León
name: Armando Pérez de Prado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Salamanca
name: M. Belen Vidriales Acosta, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04829110: Alcohol Induced de Novo Lipogenesis in Women
Official title: Alcohol Induced de Novo Lipogenesis in Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Metabolism
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of \[2H\]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Ages 21 - 45
* Healthy
* Light to moderate alcohol consumption (≤1 drink a day (\~14g) in women and ≤2 drinks a day (\~28 g) in men)
* BMI between 18.5-29.9
* Normal Nutritional Status
* Ability to speak and understand English

Exclusion Criteria:

* BMI \>29.9
* Comorbid conditions
* Any regular medications, except Oral Contraceptives
* Pregnant or Breastfeeding
* Regular exercise above activities of daily living

Primary outcomes:
measure: Mean Change in Hepatic De Novo Lipogenesis (DNL)
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: School of Health Professions at UTSW
state: Texas
Study officials:
References:
Clinical trial NCT04944810: Magnetic System in Bariatric and General Surgery
Official title: Bariatric, Revisional and General Surgery With Magnetic Assistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Bariatric Surgery Candidate
Keywords: bariatric surgery
gastric bypass
magnetic bariatric surgery
magnetic surgery
magnetic grasper
sleeve gastrectomy
revisional surgery
single-port
reduced-port
Lead sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery

Brief summary: Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.

Detailed description: Patients undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or port-reduced approach.

Also others procedures like Nissen/Sleeve gastrectomy or general surgery. The magnetic system can be used like a second assistant in the steps of the surgery for example: liver retraction, upper retraction of gallbladder, retraction of the stomach, upper retraction of jejuno-jejunal anastomosis performing a gastric bypass or closing mesenteric defects liker intermesenteric or Petersen´s defect.

Using the single-port device or port-reduced approach to obtain better aesthetic results.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* BMI Greater than 30 kg/m2 (Obesity)
* Candidate to bariatric surgery
* GERD
* Candidate to revisional bariatric surgery
* Cholecystitis or Gallstones (General Surgery)

Exclusion Criteria:

* Patients with pacemakers or electromedical implants
* Uncontrolled metabolic diseases
* Psychiatric problems

Primary outcomes:
measure: Rate of surgical complications
timeFrame: 1-2 hours
measure: Range of surgical time
timeFrame: 1-2 hours
measure: Rate of complications related to the magnetic system
timeFrame: 1-2
measure: Outcomes of magnetic grasper acting like a second assistant
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maracaibo
country: Venezuela
facility: Unidad Internacional de Cirugía Bariátrica y Metabólica
state: Zulia
Study officials:
affiliation: International Unit of Bariatric and Metabolic Surgery
name: Andres Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Unit of Bariatric and Metabolic Surgery
name: Ali Urdaneta, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02019810: Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Severe Traumatic Brain Injury With High Cerebral Pressure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.


Eligibility criteria: Inclusion Criteria:

* Traumatic brain injury (TBI) with pattern of oligemia (diastolic velocity \< 30cm/second and/or mean velocity \< 45cm/second measured with transcranial doppler or oxygen tissue pressure \< 15mmHg)
* Closed traumatic brain injury
* Isolated TBI or polytraumatism
* Age between 18 and 65 years old
* Affiliated to a social security system

Exclusion Criteria:

* Instable episodes of high cerebral pressure
* Craniectomy
* High cerebral pressure without TBI
* No autoregulation
* Current hemorrhagic shock
* Chronic cardiac failure
* Chronic renal failure
* Hyperemia measured with transcranial doppler
* Short life expectancy
* Refused consent from the family
* Protected patients by the law
* Hypersensibility to one of the treatment or sulfites

Primary outcomes:
measure: Mean blood flow velocity
timeFrame: After one hour of treatment
Secondary outcomes:
measure: Evolution of brain oxygenation under treatment
timeFrame: During one hour of treatment
measure: Dobutamine doses
timeFrame: After one hour of treatment
measure: Resistivity index on renal doppler
timeFrame: After one hour of treatment
measure: Pulsatility index on renal doppler
timeFrame: After one hour of treatment
measure: Cardiac output modifications
timeFrame: During one hour of treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
Clinical trial NCT06621810: Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults
Official title: AI-MEL: Image Analysis and Machine Learning for Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma (Skin Cancer)
Artificial Intelligence (AI)
Pediatric Cancer
Keywords: melanoma
AI
pediatric
image analysis
Children Adolescence Young Adults (CAYA)
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
name: University of Florence
name: Fundacio Clinic Barcelona
name: Hospital Clinic of Barcelona
First posted: 2024-10-01
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mainly children (up to and including 15 years of age), adolescents (16-20) and young adults (from 21 to 30 years of age)

Brief summary: The goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). The main goals it aims to achieve are:

* development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations
* development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment
* implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications

There is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Patients without a melanoma or nevus diagnosis
* images with insufficient image quality

Primary outcomes:
measure: Area Under the Receiver Operator Curve (AUROC)
timeFrame: First Assessment: Upon completion of the first training and testing cycle (approx. within 1.5 years from the start of the study). Reevaluations: at 6 and 12 months post-initial training for model improvement.
Secondary outcomes:
measure: Balanced accuracy
timeFrame: First Assessment: Upon completion of the first training and testing cycle (approx. within 1.5 years from the start of the study). Reevaluations: at 6 and 12 months post-initial training for model improvement.
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
city: Florence
country: Italy
facility: University of Florence
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: German Cancer Research Center
name: Titus J Brinker, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510910: Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Official title: Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Arthroscopy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to analgesia for patient's pain after hip arthroscopy and to also assess if this new approach will result in a reduction in post-operative narcotic use.

This study is a single-center, randomized prospective study comparing post-operative pain scores and narcotic consumption between individuals receiving acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals receiving Percocet only. Both pain management options are considered to be standard of care. Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis.

The primary objective of the study are to compare patients' narcotic consumption and reported pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate pain relief compared to a narcotic medication.


Eligibility criteria: Inclusion Criteria:

* ASA class I-II
* Patients indicated and scheduled for arthroscopic hip surgery

Exclusion Criteria:

* Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients on pain medication prior to surgery

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 7 days post-surgery
measure: Morphine-equivalent Consumption
timeFrame: 7 days post-surgery
measure: Score on Visual Analog Scale (VAS) of Pain
timeFrame: 24 hours post-surgery
measure: Score on Visual Analog Scale (VAS) of Pain
timeFrame: 4 days post-surgery
measure: Score on Visual Analog Scale (VAS) of Pain
timeFrame: 7 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Thomas Youm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01208610: The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction
Official title: The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction


Eligibility criteria: Inclusion Criteria:

1. Adult over the age of 20 pregnant women.
2. Clear consciousness, those without severe cognitive impairment, such as dementia, mental retardation or mental illness.
3. Literacy and the use of Chinese or Taiwanese.
4. Willingness to participate in the research.

Exclusion Criteria:

Refused to participate in the research

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ya-Ling Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02657512: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects
Official title: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Rivaroxaban, pharmacokinetics, activated charcoal, poisoning
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.


Eligibility criteria: Inclusion Criteria:

* affiliated or beneficiary of a social security category
* having signed the inform consent form
* having signed the genetic consent form
* BMI between 18.5 and 25
* normal clinical exam
* normal biological exam

Exclusion Criteria:

* contra-indication to rivaroxaban
* contra-indication to activated charcoal
* previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker
* Organic lesion likely to bleed
* severe liver disease
* severe kidney failure
* previous surgery within one month

Primary outcomes:
measure: plasma concentrations of rivaroxaban
timeFrame: H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Patrick MISMETTI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ollier E, Hodin S, Lanoiselee J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1.
Clinical trial NCT05131412: Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation
Official title: Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation: a a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Hematopoietic Stem Cell Transplantation
Keywords: Mesenchymal Stromal Cell
Pneumonia
Hematopoietic Stem Cell Transplantation
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 107
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent hematopoietic stem cell transplantation (HSCT) in Guangzhou Women and Children's Medical Center and got pneumonia after HSCT.

Brief summary: The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).

Detailed description: Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians.

Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated.

By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.

Eligibility criteria: Inclusion Criteria:

* patients with pneumonia after HSCT;
* patients under the age of 18 years;
* patients with normal pulmonary function before HSCT.

Exclusion Criteria:

* patients with other severe complications in progress when pneumonia occurred.

Primary outcomes:
measure: overall cure rate
timeFrame: 12 months
measure: time to cure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Hua Jiang
role: STUDY_DIRECTOR
References: