louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04864041: Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis
Official title: Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Disease
Keywords: ICU Intensive Care Units
Transthoracic Echocardiography
Left Ventricular Function
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with vaso occlusive crisis hospitalised in an intensive care unit.

Brief summary: Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.


Eligibility criteria: Inclusion Criteria:

* Hospitalisation in an intensive care unit for vaso-occlusive crisis

Exclusion Criteria:

* Pregnancy
* Individuals under guardianship
* Unsufficient echogenicity
* Thoracic pain prohibiting echocardiography assessment

Primary outcomes:
measure: Global longitudinal strain
timeFrame: Day 0
measure: Global longitudinal strain
timeFrame: Day 1
measure: Global longitudinal strain
timeFrame: Day 2
Secondary outcomes:
measure: Troponine level
timeFrame: Day 0
measure: Troponine level
timeFrame: Day 1
measure: Troponine level
timeFrame: Day 2
measure: Electrocardiogram QT interval
timeFrame: Day 0
measure: Electrocardiogram QT interval
timeFrame: Day 2
measure: Electrocardiogram ST elevation
timeFrame: Day 0
measure: Electrocardiogram ST elevation
timeFrame: Day 2
measure: Electrocardiogram negative T waves
timeFrame: Day 0
measure: Electrocardiogram negative T waves
timeFrame: Day 2
measure: Thoracic pain
timeFrame: Day 0
measure: Thoracic pain
timeFrame: Day 1
measure: Thoracic pain
timeFrame: Day 2
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Medical Intensive Care Unit
Study officials:
References:
Clinical trial NCT02131441: Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Hepatectomy
Hepatocellular Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.


Eligibility criteria: Inclusion Criteria:

* Child-pugh A-B
* Primary hepatocellular carcinoma of the left liver lobe
* Tumor size ≤5cm in diameter
* KPS≥60

Exclusion Criteria:

* Significant abnormal liver function
* Significant abnormal Heart function
* Significant abnormal lung function
* Significant abnormal kidney function

Primary outcomes:
measure: amount of bleeding
timeFrame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
measure: time of operation
timeFrame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
measure: status of the resection margins
timeFrame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
measure: bile leakage
timeFrame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
measure: abdominal adhesion
timeFrame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Secondary outcomes:
measure: overall survival
timeFrame: Participants will be followed for 5 years.
measure: disease-free survival
timeFrame: Participants will be followed for 5 years.
measure: time to disease recurrence
timeFrame: Participants will be followed for 5 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02209441: Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Gastric Cancer.
Keywords: sorafenib, gastric cancer, FOLFOX4
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-08-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: * To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer
* The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level

Detailed description: -Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe for the treatment of advanced gastric cancer.

Eligibility criteria: Inclusion Criteria:

* age \>18 years.
* documented gastric adenocarcinoma via histological or cytological examinations;
* newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
* no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
* an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* an expected survival time of at least 3 months;
* and provision of informed consent by patients prior to commencement of the study.

Exclusion Criteria:

* a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
* surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
* severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
* a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
* women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection
* epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs);
* patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously;
* allergies or possible allergies to the study medications or other drugs administered during the study;
* any patient safety or compliance issues that might jeopardize their participation in the study;
* an inability to swallow oral drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00901641: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Official title: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: cognitive training
insomnia
Lead sponsor: The Max Stern Academic College Of Emek Yezreel
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.

Detailed description: Participants in the cognitive training group train in a computer-based cognitive training program over a period of 12 weeks. An active control group train in a program involving tasks that do not engage high-level cognitive functioning over the same period.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic insomnia
* able to use a home personal computer
* have healthy dominant hand functioning
* Hebrew speakers

Exclusion Criteria:

* have any significant visual or hearing impairment
* have any significant medical, neurological or psychiatric illness that might bring about cognitive change
* have sleep disorders other than insomnia
* have any significant medical disease (including cancer, diabetes, liver, kidney, heart or lung disease)
* alcoholism or other drug abuse
* taking any medication known to affect central nervous system functioning other than sleeping pills
* historical evidence suggesting significant psychiatric conditions such as depression, psychosis or neurologic disease

Primary outcomes:
measure: sleep measures
timeFrame: 3-6 months
Secondary outcomes:
measure: Cognitive performance
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Emek Yezreel
country: Israel
facility: The Max Stern Academic College of Emek Yezreel
Study officials:
affiliation: The Max Stern Academic College Of Emek Yezreel
name: Iris Haimov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haimov I, Hanuka E, Horowitz Y. Chronic insomnia and cognitive functioning among older adults. Behav Sleep Med. 2008;6(1):32-54. doi: 10.1080/15402000701796080.
citation: Haimov I, Shatil E. Cognitive training improves sleep quality and cognitive function among older adults with insomnia. PLoS One. 2013;8(4):e61390. doi: 10.1371/journal.pone.0061390. Epub 2013 Apr 5.
Clinical trial NCT06884800: Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients
Official title: Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Toupet Fundoplication
Radiological Negative
Endoscope
Hiatal Hernia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the feasibility and effectiveness of laparoscopic toupet fundoplication (LTF) for treating gastroesophageal reflux disease (GERD) symptoms and disease-specific Quality of Life (QoL).

Detailed description: Heartburn, regurgitation, dysphagia, and chest pain are regarded as common esophageal symptoms of gastroesophageal reflux disease (GERD). On the other hand, there are very few reports of laryngopharyngeal reflux (LPR), which is associated with persistent upper airway contact, acidic and non-acidic reflux, and aerosol that results in posterior laryngitis, edema, and glottis erythema.

Proton-pump inhibitor (PPI) therapy, Laparoscopic Nissen Fundoplication (LNF), and Laparoscopic Toupet Fundoplication (LTF) have been proven to be effective for the treatment of GERD. However, the therapeutic management of patients with hiatal hernia is debated and treatment remains empirical. Previous studies on PPI therapy and LNF had been published with promising but controversial results. Therefore, the role of LTF is even less explored and evidence is scarce

Eligibility criteria: Inclusion Criteria:

* Age above 18 years old.
* Both sexes.
* Hiatal hernia patients (Hill's grade III \& IV) by endoscopy and negative by radiology indicated for Toupet fundoplication.

Exclusion Criteria:

* Recurrent patients.
* Age above 70 years old
* Unfit for surgery

Primary outcomes:
measure: Incidence of recurrence
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Incidence of anatomical failure
timeFrame: 1 year postoperatively
measure: Incidence of complications
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT02091700: ObseRvation of PeripHEral rEtinal Morphology in Normals
Official title: ObseRvation of PeripHEral rEtinal Morphology in Normal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Normal
Healthy
Normal healthy patient
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
Collaborators: name: Medical Center Ophthalmology Associates San Antonio, Texas
First posted: 2014-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects with no known retinal disease or choroidal disease.

Brief summary: To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects older than 20 years old with good general health.
* Subject is capable of giving consent.
* The subject is able and willing to comply with the study procedures.
* Subjects with ocular media clear enough to allow good quality ocular imaging.
* Normal subjects with no known retinal or choroidal disease.

Exclusion Criteria:

* Subjects under 20 years old.
* Subjects with contraindications to dilation.
* Subjects with a history of epilepsy.
* Subjects with a known allergy to iodine, shellfish or intra-venous x-ray contrast dyes.
* Subjects who are or who may be pregnant.
* Subjects with past history of any vitreoretinal disease or surgery such as retinal detachment, epiretinal membrane, or vitreous hemorrhage.
* Subjects with any ocular condition that interferes with good quality image acquisition, such as corneal opacities, cataract, and dense vitreous hemorrhage.
* Subjects with any evidence of any retinal or optic nerve disease including glaucoma.
* Subjects with any anterior segment disease with the exception of common ocular surface disorders (blepharitis, dry eye).
* Subjects with medical conditions that interfere with the subject's compliance to study procedures such as inability of the subject to maintain steady head or eye positioning as in patients of ataxia or nystagmus.
* Subjects with a history of Diabetes, uncontrolled blood pressure (defined as systolic \>/= 160mmHg and/or diastolic \>/= 90 mmHg), and Vascular Disease (cardiovascular, peripheral vascular, or cerebrovascular).
* Subjects on vasodilators.
* Subject's refusal.

Primary outcomes:
measure: Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging
timeFrame: 1 day
Secondary outcomes:
measure: Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging
timeFrame: 1 day
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: Medical Center Ophthalmology Associates
name: Michael Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03359200: Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia
Official title: Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no patient was studied

Brief summary: This study aims to evaluate the microbiota of goldmann tonometers and its possible change over the visits


Eligibility criteria: Inclusion Criteria:

* collection of material in the period

Exclusion Criteria:

* collection of material out of the period

Primary outcomes:
measure: Analysis of the microbiota in tonometers performed by means of swab collections
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goias
Study officials:
References:
Clinical trial NCT03928600: Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
Official title: Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Induced
Cervical Ripening
Keywords: induction of labor
cervical ripening
combined methods
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.

Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.

The objective is to compare the effectiveness of a combined new method to current guidelines of our department

Detailed description: We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).

Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-

Eligibility criteria: Inclusion Criteria:

* full-term (≥ 37 weeks of gestation)
* singleton
* vertex-presenting gestations
* with no contraindication to vaginal delivery
* intact membranes
* Bishop score \< 7 and cervical dilation ≤2 cm

Exclusion Criteria:

* contraindication for misoprostol
* history of previous caesarean
* rupture of membranes,
* fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)

Primary outcomes:
measure: Time to delivery
timeFrame: 3 days
Secondary outcomes:
measure: cesarean delivery rate
timeFrame: 3 days
measure: time to active labor
timeFrame: 3 days
measure: rate of delivery within 12 hours
timeFrame: 12 hours
measure: rate of delivery within 24 hours
timeFrame: 24 hours
measure: mean of maternal length of stay
timeFrame: average 3 days
measure: indication for cesarean delivery
timeFrame: 3 days
measure: composite maternal morbidity outcome
timeFrame: 6 weeks
measure: composite of neonatal morbidities
timeFrame: 30 days
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar São João
Study officials:
affiliation: Centro Hospitalar São João, Porto
name: Rita P Valente, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00032500: Evaluation of Echinacea for the Common Cold
Official title: Evaluation of Echinacea in a Human Rhinovirus Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold
Keywords: common cold
Echinacea
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-03-25
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.

Detailed description: Echinacea is a widely used herbal remedy for the common cold. Previous clinical trials designed to assess the efficacy of Echinacea for prevention or treatment of the common cold have produced inconsistent results. A variety of different Echinacea products have been used in these clinical trials. Recent studies indicate that different Echinacea preparations have dramatically different phytochemical profiles. The available clinical trial data provide no information about the potential role of the different constituents of Echinacea in common cold prevention or treatment. Our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the Echinacea preparations used. This study will address the following specific aims: 1) Evaluate the effectiveness of chemically defined extracts of E. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) Assess the correlation between specific Echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) Determine the effect of different Echinacea preparations on the host response to rhinovirus infection.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Charlottesville
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Ronald B. Turner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clemson University
name: J. David Gangemi, PhD
affiliation: Karl-Franzens-Universitaet Graz
name: Rudolf Bauer, PhD
References:
citation: Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi JD. An evaluation of Echinacea angustifolia in experimental rhinovirus infections. N Engl J Med. 2005 Jul 28;353(4):341-8. doi: 10.1056/NEJMoa044441.