louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01376856: Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection
Official title: Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: person who performed PET/CT and surgical biposy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Brief summary: The purpose of this study is to analyze pathologic and radiologic characteristics of mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and assess relationship between false positive mediastinal lymph node and TB/latent TB.


Eligibility criteria: Inclusion Criteria:

* age 20-75, men and women
* person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Exclusion Criteria:

* age \< 20
* person who don't agree with enrollment
* illiterate
* person who is diagnosed as active tuberculosis now
* person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
* pregnant woman
* person who is treated as active tuberculosis

Primary outcomes:
measure: false positive rate of Mediastinal Lymph Node
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05141656: Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
Official title: Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed as tumor of pancreas will all be considered for enrollment.

Brief summary: This study is a multi-center observational study. The start time for data collection is August 31, 2019. Patients who have been treated at our institution from August 31, 2019, who were diagnosed with pancreatic tumors on or before August 31, 2019 (diagnosed in our hospital or outside hospitals) would all meet the inclusion conditions of the study and be considered enrollment. Patients' baseline and treatment data will be collected under informed concent. The combination of medical big data governance and the leading technology of the big data platform uses real world data to improve the quality and efficiency of pancreatic tumor diagnosis, treatment and scientific research.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18, both male and female;
2. Patients with primary pancreatic tumor diagnosed by histology, cytology or imaging;
3. Clinical or pathological staging is locally advanced or metastatic pancreatic tumor (newly diagnosed or after surgery and other treatments);
4. You can accept or have not received surgery, chemotherapy, radiotherapy, local treatment or traditional Chinese medicine for tumors;
5. The subject voluntarily joined the study and signed an informed consent form voluntarily.

Exclusion Criteria:

1. Pancreatic tumors are evaluated as metastatic lesions, not primary tumors of the pancreas.

Primary outcomes:
measure: OS
timeFrame: 5 years
Secondary outcomes:
measure: DFS
timeFrame: 5 years
measure: PFS
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
state: Shanghai
Study officials:
References:
Clinical trial NCT00643656: Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion
Official title: Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Biopsy
Keywords: Liver biopsy
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 94
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: A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.


Eligibility criteria: Inclusion Criteria:

* patient requiring a liver biopsy of focal lesion
* Age upper than 18 years
* OMS : 0 to 3
* patient consent form signed

Exclusion Criteria:

* patient unable to use Visual Analog Scale (VAS)
* OMS upper than 3
* coagulation disorder
* contraindication linked to the experimental product
* patient already included in another clinical trial uncompatible with this trial

Primary outcomes:
measure: Pain measurement by using Visual Analog Scale (VAS)
timeFrame: At the end of the liver biospy
Secondary outcomes:
measure: Patient's acceptance and doctor's satisfaction
timeFrame: At the end of the liver biopsy
Other outcomes:
Locations:
city: Clichy
country: France
facility: Beaujon hospital
Study officials:
References:
citation: Meskine N, Vullierme MP, Zappa M, d'Assignies G, Sibert A, Vilgrain V. Evaluation of analgesic effect of equimolar mixture of oxygen and nitrous oxide inhalation during percutaneous biopsy of focal liver lesions: a double-blind randomized study. Acad Radiol. 2011 Jul;18(7):816-21. doi: 10.1016/j.acra.2011.01.025. Epub 2011 Apr 20.
Clinical trial NCT01357356: Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nocturia
Lead sponsor: Serenity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 750
Sex: ALL
Minimum age (years): 50
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 investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.


Eligibility criteria: Inclusion Criteria:

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night

Exclusion Criteria:

* CHF
* Diabetis Insipidus
* Renal Insufficiency
* Hepatic Insufficiency
* Incontinence
* Illness requiring systemic steroids
* Malignancy within the past 5 years
* Sleep Apnea
* Nephrotic Syndrome
* Unexplained Pelvic Mass
* Urinary Bladder Neurological dysfunction
* Urinary Bladder Surgery or Radiotherapy
* Pregnant or Breast Feeding

Primary outcomes:
measure: Change in # of Mean Nocturic Episodes Per Night
timeFrame: 12 weeks
measure: Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: Serenity R&D
state: New York
Study officials:
References:
Clinical trial NCT05549856: Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions
Official title: Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Pancreatic Lesions
EUS-FNB
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
name: Shenzhen People's Hospital
First posted: 2022-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.

Detailed description: The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75 years;
* Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
* Plan to receive EUS-FNB.
* Able to obtained informed consent.

Exclusion Criteria:

* Had expected difficulty of endoscope insertion
* That no lesion in the pancreas is identified by EUS
* Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
* Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time \>1.5 or a platelet count \<50,000 cells/mL
* Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
* Vulnerable groups such as pregnant women or patients with mental disorders;
* Patients unable to understand and/or read the consent form.

Primary outcomes:
measure: diagnostic accuracy
timeFrame: 12 months
Secondary outcomes:
measure: Samples tissue integrity
timeFrame: 12 months
measure: Samples cellularity
timeFrame: 12 months
measure: the diagnostic in relation to the number of needle passes
timeFrame: 12 months
measure: Time (minutes) of the procedures with dry suction and wet suction
timeFrame: 12 months
measure: Percentage of procedure related adverse events [Safety]
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Li Yue, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103556: Edible Oils in the Treatment of Constipation of Hemodialysis Patients
Official title: Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Constipation
Rome III criteria
Hemodialysis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-04-04
Enrollment: 50
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 was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Constipated patients by Rome III criteria
* Hemodialysis \> 3 months

Exclusion Criteria:

* Diagnosis of gastrointestinal disease other than constipation
* Previous intolerance to the oils used in the study
* Cognitive limitations

Primary outcomes:
measure: Score of constipation symptoms
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Lilian Cuppari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Christiane I Ramos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429256: Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
Official title: Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycobacterium Chimaera Infections
Keywords: cardiac bypass heater-cooler devices
cardiac surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel

Brief summary: Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices.

So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.


Eligibility criteria: Inclusion Criteria:

* Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel

Exclusion Criteria:

* none

Primary outcomes:
measure: summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
timeFrame: at baseline
measure: summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Cardiac Surgery Clinic University Hospital Basel
Study officials:
affiliation: Cardiac Surgery Clinic University Hospital Basel
name: Oliver Reuthebuch, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422056: Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty
Official title: Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cleft Palate
Hemorrhage
Keywords: Cleft Palate
Hemorrhage
Palatoplasty
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.

Detailed description: Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.

Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.

Eligibility criteria: Inclusion Criteria:

* Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital

Exclusion Criteria:

* Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
* Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
* History of bleeding disorders in first-degree relatives;
* Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
* Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
* Known allergy to tranexamic acid.

Primary outcomes:
measure: intraoperative bleeding
timeFrame: during surgery
Secondary outcomes:
measure: Incidence of wound dehiscence
timeFrame: 5 days
measure: Oronasal fistulas
timeFrame: 1 month
measure: incidence of significant bleeding complications
timeFrame: During hospital stay, an expected average of 2 days
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Guilherme C Arantes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130309: Results of a Mobile Unicompartimental Knee Prosthesis
Official title: Survival Rates of Atients Wearing a Mobile Unicompartimental Knee Prosthesis for the Past 10 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Replacement
Keywords: Knee
Replacement
Mobile-bearing
unicompartmental prosthesis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 70
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 wearing unicompartmental knee prosthesis with mobile plate for over 10 years

Brief summary: The unicompartmental knee prosthesis has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models.

In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing unicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses and mobile-bearing prostheses


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients wearing unicompartmental knee prosthesis with mobile plate for over 10 years

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Compare retrospectively data concerning survival rates of patients wearingunicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed and mobile bearing prosthesis.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre de Chirurgie Orthopédique et de la Main (CCOM)
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05543109: Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
Official title: Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block for Pain Management in Pediatric Patients With Developmental Dysplasia Sia of the Hip Joint, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Hip Dysplasia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip

Detailed description: All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.

Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.

The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.

Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing undergo acetabuloplasty
* Anesthesiologists (ASA) physical status of I to II

Exclusion Criteria:

* Known allergy to local anesthetic
* Infection at the block site.

Primary outcomes:
measure: Intraoperative anesthetic requirement
timeFrame: 1 hour
measure: Postoperative analgesic requirements
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mona Mohamed Mogahed
state: Elgharbia
Study officials:
References: