louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00741247: Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA
Official title: Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: staging
Endobronchial ultrasound
Endoscopic ultrasound
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2008-08-26
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (NSCLC)
* Potentially operable patients

Exclusion Criteria:

After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan)

* M1 disease
* Inoperable T4 disease
* Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
* Confirmed supraclavicular lymph node metastasis
* Pancoast tumors
* Medically inoperable patients
* Contraindications for bronchoscopy

Primary outcomes:
measure: The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone
timeFrame: June 2009
Secondary outcomes:
measure: The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.
timeFrame: June 2009
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: NCCKorea
Study officials:
References:
citation: Hwangbo B, Lee GK, Lee HS, Lim KY, Lee SH, Kim HY, Lee HS, Kim MS, Lee JM, Nam BH, Zo JI. Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer. Chest. 2010 Oct;138(4):795-802. doi: 10.1378/chest.09-2100. Epub 2010 Mar 26.
Clinical trial NCT02164747: Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units
Official title: Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nursing Homes Residents
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2014-06-17
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.


Eligibility criteria: Inclusion Criteria:

* All residents of selected nursing homes

Exclusion Criteria:

* None

Primary outcomes:
measure: Length of hospital stay
timeFrame: Within 1 year after start of the study
Secondary outcomes:
measure: Patient transportation to a emergency unit
timeFrame: Within 1 year after start of the study
measure: Number of hospitalizations
timeFrame: Within 1 year after start of the study
measure: Global costs
timeFrame: Within 1 year after start of the study
Other outcomes:
Locations:
city: Boussy St Antoine
country: France
facility: Résidence La Gentilhommière
city: Evry
country: France
facility: Résidence Les Tisserins
city: Milly la Forêt
country: France
facility: Résidence Notre Dame d'Espérance
city: Pussay
country: France
facility: Le Centenaire
city: Saint Germain lès Arpajon
country: France
facility: Résidence de l'Orge
Study officials:
affiliation: DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
citation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
Clinical trial NCT05449847: Plasma MicroRNA for Prediction of Hepatocellular Carcinoma
Official title: Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 31
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HCV patients

Brief summary: 100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.


Eligibility criteria: Inclusion Criteria:

* Complicated hepatitis C by HCC
* Complicated hepatitis C by liver cirrhosis
* Complicated hepatitis C by steatohepatitis
* uncomplicated hepatitis C

Exclusion Criteria:

* pre-portal fibrosis secondary to previous bilharzial disease
* pre-portal fibrosis secondary to alcoholic fatty liver
* The presence of hepatic malignancy other than HCC
* decompensated cirrhosis
* hepatorenal failure
* hepatic manifestations of congestive heart failure.

Primary outcomes:
measure: Relation between MicroRNA and HCV
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha university
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT02090647: Aesthetic Evaluation of Different Abutment Materials for OsseoSpeed Implants
Official title: Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aesthetic Evaluation
Implant Survival Rate
Keywords: dental implant, aesthetic, implant abutment
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants .

A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the aesthetic of implant-prosthesis rehabilitations.


Eligibility criteria: Inclusion Criteria:

* aged over 18 years
* dental implant rehabilitation requested
* at least 1 tooth missing in areas between 1.5-3.5 and 3.5-4.5
* sufficient bone volume for implant placement ( length 10-15mm; diameter 2.5-4mm, bone quality between class I and III of Lekholm and Zarb).
* informed consensus acceptance

Exclusion Criteria:

* systemic pathologies that represent controindication to implantology
* smoking (more than 10 cigarettes per day)
* severe bruxism
* untreated periodontitis

Primary outcomes:
measure: aesthetic evaluation
timeFrame: 12 months
Secondary outcomes:
measure: implant survival rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte
Study officials:
References:
Clinical trial NCT03714347: The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
Official title: The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Neoplasm
Keywords: cerebral oxygen monitoring
intracranial surgery
general anesthesia
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.

Detailed description: Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.

Eligibility criteria: Inclusion Criteria:

* Intracranial surgery will be performed
* Age 25-75
* ASA in the I-II-III risk group

Exclusion Criteria:

* Under GKS 15
* heart failure,
* renal insufficiency,
* liver failure,
* congenital neurological deficits

Primary outcomes:
measure: cerebral oxygen monitoring data
timeFrame: cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centrum
Study officials:
affiliation: Trakya University
name: Emre Deren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02920047: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

Detailed description: This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.

Eligibility criteria: Inclusion Criteria:

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Primary outcomes:
measure: Cmax and AUClast of Fimasartan, Amlodipine
timeFrame: Time Frame: 0~144 hour after medication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01588847: Anesthesia and Cancer Recurrence im Malignant Melanoma
Official title: Long-term Outcome After Radical Lymph Node Dissection of Malignant Melanoma. Comparison Between Regional Versus General Anesthesia With Respect to Impact of Perioperative Immunoediting and Validation of New Potential Predictive Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Melanoma
Keywords: perioperative immunoediting
potential predictive biomarkers
lymph node dissection
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 230
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: Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.

The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Detailed description: Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Female patients who are pregnant or nursing
* Multiple organ failure
* Contraindications

Primary outcomes:
measure: Overall survival
timeFrame: five years
Secondary outcomes:
measure: Changes of the total amount of immune cells
timeFrame: 15 minutes before end of surgery
measure: Changes of the total amount of immune cells
timeFrame: 24 hours postoperatively
measure: Changes of the total amount of immune cells
timeFrame: Five days postoperatively
measure: Potential predictive biomarkers
timeFrame: 15 minutes before end of surgery
measure: Potential predictive biomarkers
timeFrame: 24 hours postoperatively
measure: Potential predictive biomarkers
timeFrame: Five days postoperatively
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
Study officials:
affiliation: University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
name: Hugo K Van Aken, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05890547: Recurrent Salivary Gland Infections in Covid-19
Official title: Recurrent Salivary Gland Infections in Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Salivary Gland Infections in Covid-19
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Brief summary: The aim of this study is to find out the role of Covid-19 in salivary gland infection and its recurrence.

Detailed description: This is a prospective clinical study of 60 patients. The study will be performed in the Otolaryngology department, Faculty of Medicine, Benha University during the duration from June 2023 to December 2023.

Inclusion criteria:

Adult patients aged ≥18 years.

Exclusion criteria:

* Patients with known autoimmune diseases,
* Diabetes Mellitus
* History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
* History of facial nerve palsy,
* Oral and dental diseases including chronic sialadenitis or sialolithiasis.
* previous oral surgery.

Patients were divided into two equal groups each of 30 patients according to the cause of infection. Group (1) comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs and group (2) comprises of 30 patients with non-Covid-19 infection as a control group.

All patients will be submitted to full ENT and intraoral clinical examination. We will Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Exclusion Criteria:

* Patients with known autoimmune diseases,
* Diabetes Mellitus
* History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
* History of facial nerve palsy,
* Oral and dental diseases including chronic sialadenitis or sialolithiasis.
* previous oral surgery.

Primary outcomes:
measure: occurrence or recurrence of sialoadenitis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha university hospitals
Study officials:
affiliation: medical school
name: Eslam Abu Shady, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286247: Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Breast Cancer (LABC)
Lead sponsor: Introgen Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.


Eligibility criteria: Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer

Male or female

18 years or older

Adequate bone marrow, liver, and kidney function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00180947: Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
Official title: Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rhabdomyosarcomas
Neoplasms, Connective and Soft Tissue
Ewing Tumor
Osteosarcomas
Neuroblastomas
Medulloblastomas
Keywords: Soft parts tissue
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 210
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.


Eligibility criteria: Inclusion Criteria:

* Age \> 12 months and \< 25 years
* Measurable disease
* Score of Lansky \> 30 or World Health Organization (WHO) score \< 2
* Life expectancy \> 2 months
* Satisfactory hematologic conditions:

  * Polynuclear neutrophiles \> 1 X 10\^9/l.
  * Platelets \> 100 X 10\^9/l or \> 50 X 10\^9 in the event of medullary invasion.
* Creatinine \< 1.5 of normal for age or clearance \> 70 ml/min/1.73 m2
* Normal hepatic function:

  * Bilirubin \< 3 N
  * ASAT and ALAT \< 2,5 N).
* Absence of toxicity of bodies (Rank \> 2 according to coding National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\] version 2.0)
* Absence of antecedent of hematuric cystitis to repetition
* Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects

Exclusion Criteria:

* Does not satisfy the criteria of eligibility

Primary outcomes:
measure: To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
Secondary outcomes:
measure: To evaluate the hematologic tolerance of this association
measure: To evaluate the pharmacokinetics of injectable Vinorelbine
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Odile OBERLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: