louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02848703: Study " COFLORES "
Official title: Study " COFLORES ":Imaging of Coronary Reserve Without Tracers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Perfusion
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).

Goal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection


Eligibility criteria: Inclusion Criteria:

* People having no heart disease or treatment referred to cardiology
* People having no cons -indications to MRI
* People having no cons -indications to gadolinium ;
* People not wearing implantable devices
* People not wearing metallic foreign bodies or risk (eg . Business of steel, etc .. )
* People having no cardiovascular risk factor
* Person subject to the social security scheme
* Nobody agreeing to participate in the study and who signed the informed consent

Exclusion Criteria:

* Refusal to go spontaneous or MRI because of claustrophobia important
* Trouble rhythm making MRI uninterpretable

Primary outcomes:
measure: Myocardial perfusion
timeFrame: 1day
Secondary outcomes:
measure: the myocardial energetic status
timeFrame: 1day
measure: the myocardial sodium
timeFrame: 1day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03276403: Primary Graft Dysfunction Score in Lung Transplantation
Official title: Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplant; Complications
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving double lung transplantation

Brief summary: The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.


Eligibility criteria: Inclusion Criteria:

* Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema
* No restrictions regarding donor lungs (marginal donors, EVLP possible)
* No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)

Exclusion Criteria:

* Single-lung transplantation
* Heart-lung transplantation
* Re-transplantation
* Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
* Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling
* No access to the femoral artery possible
* Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary

Primary outcomes:
measure: Primary graft dysfunction
timeFrame: 72 hours after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Medical University of Vienna
name: Konrad Hoetzenecker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02137603: Fast Track Appendectomy for Suppurative Appendicitis
Official title: Fast Track Appendectomy in Pediatric Patients With Intraoperative Findings of Suppurative Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suppurative Appendicitis
Keywords: Suppurative appendicitis, appendicitis, pediatric
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 5-18
* Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
* Intraoperative findings of suppurative appendicitis

Exclusion Criteria:

* Pregnancy
* Complex medical history not appropriate for same day discharge

Primary outcomes:
measure: Post Operative Length of Stay
timeFrame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Secondary outcomes:
measure: Thirty Day Complication Rate
timeFrame: Thirty days
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Nicole M Chandler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057303: Studying Gene Expression in Tissue Samples From Young Patients With Acute Myeloid Leukemia
Official title: EVI-1 Expression in Pediatric AML With 11q23 Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-27
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of pediatric acute myeloid leukemia with 11q23 abnormalities

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at gene expression in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Examine mRNA from pediatric patients with acute myeloid leukemia with 11q23 translocations by reverse transcriptase-PCR to quantify expression of EVI1 splice variants.

OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of pediatric acute myeloid leukemia with 11q23 abnormalities

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Quantification of the expression of EVI1 splice variants
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Amy Heerema-McKenney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521703: Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
Official title: Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Malabsorption Syndrome
Gastroesophageal Reflux Disease
Abdominal Pain
Keywords: endoscopy, gastrointestinal
lidocaine
propofol
child
adolescent
Lead sponsor: Hospital Infantil Cândido Fontoura
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 78
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is some controversy in the medical literature regarding the effectiveness of topical lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children, deep sedation and general anesthesia are often used to sedate children submitting to this procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this drug can only be used with an anesthesiologist in Brazil. Its main side effects include hypotension, respiratory depression and local pain. Lidocaine is frequently used as premedication, and the rationale is that lowering patient discomfort could lower the required dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients perceive this medication as uncomfortable. This study aims to compare sedative drug doses between patients who were given either placebo or topical lidocaine.

Detailed description: This study is a randomized double-blind placebo-controlled clinical trial.

Primary outcome: propofol doses required to achieve adequate sedation.

Population: children submitting to upper digestive endoscopy, weight \> 30 kg and age between 8 and 18 years.

Exclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication to either lidocaine or propofol.

Estimated sample: 160 patients. Placebo: tannic acid 0.5%

Eligibility criteria: Inclusion Criteria:

* Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years

Exclusion Criteria:

* Neurological disorders
* Psychiatric disorders
* Specific contra-indication to lidocaine
* Specific contra-indication to propofol

Primary outcomes:
measure: propofol dose required to achieve adequate sedation to upper digestive endoscopy
timeFrame: one hour
Secondary outcomes:
measure: incidence of tachycardia (heart rate > 120) during the procedure
timeFrame: one hour
measure: incidence of hypoxemia (SpO2 < 94%) during procedure
timeFrame: one hour
measure: severity of sore throat after the procedure
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Infantil Cândido Fontoura
Study officials:
affiliation: UNIFESP/EPM
name: Rodrigo S Machado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05037903: Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study
Official title: Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: A Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a qualitative study of participants who have taken part in a randomized controlled trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose of the qualitative study is to explore participant perceptions of taking part in the RCT to further develop and improve the new treatment protocol.


Eligibility criteria: Inclusion Criteria:

* Principal diagnosis of ADHD inattentive presentation
* 18 years of age or older
* If on medication, it needs to be well-established since three months, and
* Prior psycho-educational intervention

Exclusion Criteria:

* Intellectual impairment
* Substance use disorder
* Difficulties in adherence to medical or other treatment
* Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
* Simultaneous psychological treatment

Primary outcomes:
measure: Qualitative interview data
timeFrame: 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Health Care Services, Region Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847703: Robotic Versus Abdominal Surgery for Endometrial Cancer
Official title: Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Neoplasms
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

Detailed description: Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).

Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)

Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.

Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* High risk endometrial cancer

Exclusion Criteria:

* WHO performance\>1
* Severe comorbidity, ASA\>3
* Unable to understand information

Primary outcomes:
measure: Number of harvested lymph nodes
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence of cancer
timeFrame: 3 years
measure: Lymphatic side-effects
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Healthcare cost
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Henrik Falconer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salehi S, Avall-Lundqvist E, Legerstam B, Carlson JW, Falconer H. Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial. Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.
Clinical trial NCT01717703: Sugars-sweetened Commercial Beverages on Short-term Food Intake
Official title: Effect of Sugars-Sweetened Commercial Beverages on Short-Term Food Intake Regulation in Normal Weight and Overweight/Obese 9-14 Year Old Boys and Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: prevention
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
First posted: 2012-10-30
Enrollment: 55
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.


Eligibility criteria: Inclusion Criteria:

* healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight

Exclusion Criteria:

* restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments

Primary outcomes:
measure: Food intake (kcal)
timeFrame: 60 min after the treatment
Secondary outcomes:
measure: Subjective appetite (in mm)
timeFrame: 0-90 min
Other outcomes:
Locations:
city: Bedford
country: Canada
facility: Department of Applied Human Nutrition
state: Nova Scotia
Study officials:
References:
Clinical trial NCT05903703: Canagliflozin With Gemcitabine in Pancreatic Carcinoma
Official title: Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: College of Pharmaceutical Sciences at Zhejiang University
name: The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University
First posted: 2023-06-15
Enrollment: 20
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: Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.


Eligibility criteria: 1. Inclusion criteria: # Age ≥18 years old; #Metastatic or unresectable pancreatic cancer is confirmed through histology or cytology; # Estimated survival time \> 3 months; # Without any chemotherapy treatment or more than one month from the end of the last chemotherapy course; #ECOG physical status score 0-2;
2. Exclusion criteria: # patients who had allergic reaction to therapeutic drugs; # patients with other types of cancer; # Patients with severe diseases of heart, liver, kidney, etc.; (4) gastrointestinal dysfunction or unable to oral medication.
3. Shedding/eliminating criteria: exiting in the midway; Lost to follow-up during the follow-up period; Treatment was not continued according to the treatment protocol.

Primary outcomes:
measure: Evaluation the clinical complete response (CR) at 6 weeks intervals
timeFrame: 18 weeks
measure: Evaluation the clinical partial response (PR) at 6 weeks intervals
timeFrame: 18 weeks
measure: Evaluation the clinical stable disease (SD) at 6 weeks intervals
timeFrame: 18 weeks
measure: Evaluation the clinical disease progression (PD) at 6 weeks intervals
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou first people's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00864903: A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
Official title: A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Viral Meningitis
Keywords: enterovirus
aseptic meningitis
real time PCR
diagnostics
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 0
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.

Brief summary: A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.

Detailed description: MND's new enzymatic assay is based on the detection of a specific viral enzyme through the detection of its enzymatic reaction. The detection of a specific enzymatic reaction is indicative to the presence of the specific virus in a biological specimen. This study will compare this diagnostic assay to RT-PCR for diagnosis of enteroviral infection in cerebrospinal fluid. CSF samples will be taken from children undergoing a spinal tap at the pediatric ER due to a suspicion of meningitis. A total of 100 samples will be collected, from children 0-16 years old who's parents agreed on participation in the study. A comparison of the enzymatic assay to RT-PCR as well as calibration and validation of the new assay will be done with the harvested samples, for a rapid and accurate identification of Enterovirus in human cerebrospinal fluid.

Eligibility criteria: Inclusion Criteria:

* any child undergoing a spinal tap
* parents agreed on participation

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ness Ziona
country: Israel
facility: MND Diagnostics
Study officials:
affiliation: Shaare Zedek Medical Center
name: Yechiel Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
References: