louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03978481: Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
Official title: Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Gastric cancer
Helicobacter pylori
Subtotal gastrectomy
Overall survival
Metachronous cancer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 3700
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2018

Brief summary: In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.

Detailed description: In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status

Exclusion Criteria:

* Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
* Patients received palliative treatment

Primary outcomes:
measure: Overall survival
timeFrame: From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months
Secondary outcomes:
measure: Gastric cancer-specific (disease-free) survival
timeFrame: From date of initial curative surgery for gastric cancer, until the date of diagnosis of gastric cancer recurrence or the date of death, whichever comes first, up to 60 months
measure: Metachronous cancer (remnant stomach cancer)
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT03302481: Mitochondrial Metabolism and Hepatic Complications of Obesity
Official title: Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity surgery
liver
mitochondria
steatosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
Primary purpose: OTHER

Brief summary: The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.

Detailed description: The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis. The protocols involves a per-operative hepatic needle biopsy for mitochondria characterization and histological scoring of steatosis, inflammation, and fibrosis

Eligibility criteria: Inclusion Criteria:

* adult men and women
* affiliated to a social security
* candidate for laparoscopic obesity surgery

Exclusion Criteria:

* Excessive alcohol consumption:\> 20 g / day (woman),\> 30 g / day (male)
* Chronic viral hepatitis B or C
* Genetic hemochromatosis
* Taking the following drugs for at least 3 months up to 6 months before the scheduled date of obesity surgery: systemic corticosteroids, amiodarone, methotrexate
* Wilson's disease
* autoimmune hepatitis
* alpha 1-antitrypsin deficiency
* abetalipoproteinemia
* Contraindications to liver biopsy

Primary outcomes:
measure: Association between nonalcoholic steato-hepatitis and mitochondria morphological markers
timeFrame: Until 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: David JACOBI, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03679481: The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
Official title: The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Blood Loss Following Open Femur Fracture Surgery
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 0
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: The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

Exclusion Criteria:

* Preoperative use of any anticoagulant
* History of deep venous thrombosis or pulmonary embolus
* Allergy to TXA
* Hepatic dysfunction (AST/ALT \> 60)
* Renal dysfunction (Cr \> 1.5 or GFR \< 30)
* History of cerebrovascular accident in the past 12 months
* Active coronary artery disease (event in the past 12 months)
* Presence of drug-eluting stent
* Color blindness
* Presence of an additional acute injury that could contribute to blood transfusion requirements

Primary outcomes:
measure: Transfusion requirements as assessed by number of packed red blood cell units received
timeFrame: from the time of surgery to hospital discharge (about 3-5 days)
Secondary outcomes:
measure: Surgical blood loss as assessed by change in red blood cell volume
timeFrame: baseline, while in PACU (which is about 4-6 hours after surgery)
measure: Surgical blood loss as assessed by an intraoperative cell salvage machine
timeFrame: at the time of surgery
measure: Length of hospital stay
timeFrame: from the time of hospital admission to the time of hospital discharge (about 5 days)
measure: Number of participants with complications
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stephen J Warner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06422481: Echocardiographic Measurement of Myocardial Work
Official title: Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Physiological Phenomena
Intensive Care Unit Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Indication to fluid administration left to the discretion of the attending physician
* Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician.

Exclusion Criteria:

* Patients under protection.
* Patients with do not ressuscitate order.
* Patients with severe left-side or right-side valvulopathy.
* Patients with atrial fibrillation.
* Patients with ventricular aneuvrysm or severe regional wall motion abnormalities.
* Patients with a pacemaker.
* Patients' objections to the collection of their health data.

Primary outcomes:
measure: Determine the feasibility of echocardiographic measurement
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: measurement of myocardial by cardiac ultrasound during fluid administration
timeFrame: through study completion, an average of 1 year
measure: measurement of myocardial by cardiac ultrasound norepinephrine administration
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE ARCHET
state: CHU De Nice
city: Nice
country: France
facility: CHU de NICE PASTEUR
state: CHU De Nice
city: Marseille
country: France
facility: Aphm Hopital La Timone
Study officials:
References:
Clinical trial NCT02181881: DuoPACT Pilot Intervention
Official title: Relationship Factors and HIV Treatment Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-07-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention acceptability and feasibility.


Eligibility criteria: Inclusion Criteria:

1. Gay male couple.
2. One or both partners must be HIV positive and on antiretroviral medications.

Exclusion Criteria:

Must be able to consent to and follow study protocol.

Primary outcomes:
measure: Satisfaction with the intervention
timeFrame: 3 months
Secondary outcomes:
measure: Feasibility
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for AIDS Prevention Studies
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mallory O Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03631381: Retrospective Study of Carotid Surgery in Dijon
Official title: Retrospective Study of Carotid Surgery in Dijon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Stenosis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients operated for carotid stenosis in the cardiovascular and thoracic surgery department at Dijon University Hospital since 2000

Brief summary: The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.

The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.

It would be of great use to have the statistics obtained in previous years to continue improving our practices.


Eligibility criteria: Inclusion Criteria:

all patients operated for carotid stenosis at Dijon University Hospital

Exclusion Criteria:

none

Primary outcomes:
measure: mortality rate (%)
timeFrame: Day 30
measure: incidence of complications (%)
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01920581: Use of Benzodiazepines and Z Drugs in the Elderly
Official title: Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Benzodiazepines and Related Drugs Users
Keywords: CEIP
pharmacodependance
addictovigilance
benzodiazepines and benzodiazepines related drugs
elderly
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 1100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 years old or more volunteers,with benzodiazepines or benzodiazepines related drugs treatment for at least three months, written consent and without exclusion criteria.

Brief summary: The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.

Detailed description: 1100 patients will be recruited by pharmacists. They will answer to a standardized questionnaire assessing their benzodiazepines or related drugs usage (phone contact).

Pharmacists are recruited by all French Centers For Evaluation and Information on Pharmacodependence (CEIP).

Eligibility criteria: Inclusion Criteria:

* 65 years old or more,
* benzodiazepines or benzodiazepines related drugs treatment for at least three months,
* written consent and without exclusion criteria.

Exclusion Criteria:

* no written consent form
* difficulties to understand or speak french

Primary outcomes:
measure: Dependence according to DSM IV criteria
timeFrame: 2 years
Secondary outcomes:
measure: withdrawal syndrome
timeFrame: 2 years
measure: psychiatric comorbidities
timeFrame: 2 years
measure: Dependence scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CEIP Bordeaux
city: Caen
country: France
facility: CEIP Caen
city: Grenoble
country: France
facility: CEIP Grenoble
city: Lille
country: France
facility: CEIP Lille
city: Lyon
country: France
facility: CEIP Lyon
city: Marseille
country: France
facility: CEIP Marseille
city: Montpellier
country: France
facility: CEIP Montpellier
city: Nancy
country: France
facility: CEIP Nancy
city: Nantes
country: France
facility: CEIP Nantes
city: Paris
country: France
facility: CEIP Paris
city: Toulouse
country: France
facility: CEIP Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Pascale Jolliet, PUPH
role: STUDY_DIRECTOR
References:
citation: Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network; Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.
Clinical trial NCT01712295: 17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
Official title: New Formulation of Salicylate to Improve Treatment of Common Skin Warts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Warts
Keywords: Warts
salicylic acid
ethyl pyruvate
Lead sponsor: Grossman, Michael, D.P.M.
Sponsor class: INDIV
Collaborators: name: Main Line Health
First posted: 2012-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.

Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.


Eligibility criteria: Inclusion Criteria:

* evidence of skin plantar wart(s)

Exclusion Criteria:

* iodine allergy

Primary outcomes:
measure: To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
timeFrame: 16 weeks
Secondary outcomes:
measure: To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Ardmore
country: United States
facility: Main Line Foot and Ankle Center
state: Pennsylvania
Study officials:
name: Michael R Grossman, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03381495: The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Official title: The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Pregnancy Outcomes
Psychological Disorder
Keywords: Epidural Labor Analgesia
length of labor stage
fetal outcomes
maternal outcomes
postpartum depression
exercise
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.


Eligibility criteria: Inclusion Criteria:

healthy and full term pregnant women

Exclusion Criteria:

the pregnant women with complications

Primary outcomes:
measure: Labor duration
timeFrame: At the end of the delivery
Secondary outcomes:
measure: 1 minute Apgar index
timeFrame: 1 minute after the infant is born
measure: 5 minute Apgar index
timeFrame: 5 minutes after the infant is born
measure: Visual Analogue Scores(VAS)
timeFrame: 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
measure: Modified Bromage scores
timeFrame: 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
measure: Postpartum depression
timeFrame: 3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.
measure: The mode of delivery
timeFrame: At the end of delivery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
citation: Zha Y, Gong X, Yang C, Deng D, Feng L, Luo A, Wan L, Qiao F, Zeng W, Chen S, Wu Y, Han D, Liu H. Epidural analgesia during labor and its optimal initiation time-points: A real-world study on 400 Chinese nulliparas. Medicine (Baltimore). 2021 Mar 5;100(9):e24923. doi: 10.1097/MD.0000000000024923.