louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02700438: Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure
Official title: Perianal Application of Glyceryl Trinitrate 0.4% Ointment vs Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study was performed. Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .

Detailed description: Patients were randomly assigned to experimental and control groups: those patients undergoing PPTNS (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

PPTNS: The Urgent PC Neuromodulation System® (Uroplasty, Minnetonka, MN, USA) was used. Subjects underwent one 30-min session 2 days per week for 8 consecutive weeks in an outpatient clinic. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion. PPTNS was undertaken at the highest amplification (0-20 mA) at a frequency of 20 Hz, causing neither a motor response nor pain.

Compliance with the treatment and healing rate of chronic anal fissure was investigated.

Eligibility criteria: Inclusion Criteria:

* persistent anal fissure after the failure of hygienic and dietary measures over at least a 6-week period

Exclusion Criteria:

* associated anal pathologies
* intestinal inflammation disorders
* fissures secondary to underlying diseases
* patients with previous history of headaches

Primary outcomes:
measure: Number of participants who discontinued the assigned treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Healing, defined as disappearance of symptoms and evidence of fissure reepithelization
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Garcilaso Clinic
name: Eduardo Barna, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06149338: The Rate of Successful Intubation and the Required Time for Intubation, Using Vie Scope and Macintosh Laryngoscope Will be Compared, in Order to Evaluate the Efficacy of Vie Scope in Comparison With Macintosh in Expected Easy Airways.
Official title: Vie Scope Versus Macintosh Laryngoscope in Expected Easy Airways: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngoscopy
Keywords: Vie Scope
Macintosh
Rate of successful intubation
Intubation time
Lead sponsor: St. Andrew's General Hospital, Patras, Greece
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rate of successful intubation and the required time for intubation, using Vie Scope and Macintosh Laryngoscope will be compared, in order to evaluate the efficacy of Vie Scope in comparison with Macintosh in expected easy airways. Hence, a prospective randomized controlled single-blind superiority clinical trial will be conducted.

Inclusion criteria: patients of both sexes, positive or negative rapid test for COVID-19 or possible contamination, age ≥18 years old, BMI: 18.5 - 30 kg/m2, visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.

Exclusion criteria: age under 18 years old, BMI under 18.5 kg/m2 and BMI over 30 kg/m2, visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.

The laryngoscopy and intubation of the patients will be attempted by the same person-resident of Anesthesiology, under the supervision of experienced Anesthesiologist consultants.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* Positive or negative rapid test for COVID-19 or possible contamination
* Age ≥18 years old
* BMI: 18.5 - 30 kg/m2
* Visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.

Exclusion Criteria:

* Age under 18 years old
* BMI under 18.5 kg/m2 and BMI over 30 kg/m2
* Visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.

Primary outcomes:
measure: Rate of Successful Intubation With One Attempt
timeFrame: Evaluation immediately after the first attempt of intubation
measure: Mean Intubation Time
timeFrame: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth
Secondary outcomes:
measure: Rate of Successful Intubation
timeFrame: Evaluation immediately after the intubation attempts
measure: Visualization of the Glottis, According to Cormack Lehane Classification
timeFrame: This outcome will be evaluated during laryngoscopy and intubation of each patient
Other outcomes:
Locations:
city: Patra
country: Greece
facility: Saint Andrew's General Hospital of Patras
Study officials:
References:
Clinical trial NCT00890838: Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
Official title: Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Valvular Surgery
Inflammation
Keywords: IVFO
Inflammation
Valvular surgery
Inflammatory status
Infectious complications
Lead sponsor: Nizam's Institute of Medical Sciences University, India
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. To the investigators' knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.


Eligibility criteria: Inclusion Criteria:

1. Adult male or female patients undergoing valvular surgeries
2. Age 18-50 years
3. The patients who give written informed consent

Exclusion Criteria:

1. Refusal to participate in the study
2. Allergy to any of the constituents of nutritional products
3. HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
4. Severe cardiac disease, hepatic disorders (total bilirubin \> 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
5. Uncontrolled severe renal failure (Serum creatinine \> 2 mg/dL) without dialysis/hemofiltration
6. Pregnant or nursing women
7. Participation in any other clinical trial within the last 2 months

Primary outcomes:
measure: IL-6, 8, 10, HS-CRP
timeFrame: 5 days
Secondary outcomes:
measure: Infectious complications
timeFrame: 5 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: NIzam's Institute of Medical Sciences
state: AP
Study officials:
affiliation: Professor and Head, Department of ANesthesia and critical care
name: Dr R Gopinath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01919138: Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units
Official title: Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units of National Taiwan University Hospital: Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 762
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paitent with Severe Spesis in Surgical Intensive Care Units of National Taiwan University Hospital

Brief summary: Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.

Detailed description: Patients suffered from severe sepsis or septic shock have a mortality of 20\~54%. It is major healthcare problems, affecting millions of individuals around the world each year. An international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. Lots of medical centers have joined the Surviving Sepsis Campaign and follow the latest guideline. Many reports have shown that Surviving Sepsis Campaign Guideline can reduce patient mortality.

In surgical intensive care units of National Taiwan University Hospital (NTUH), the Surviving Sepsis Campaign Guideline was conducted since 2009. Our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of NTUH by retrospective review of medical chart.

Eligibility criteria: Inclusion Criteria:

* Patients were diagnosed as severe sepsis in Surgical Intensive Care units of National Taiwan University Hospital

Exclusion Criteria:

* \< 20 years old

Primary outcomes:
measure: survival rate of severe sepsis patients in Surgical Intensive Care Units
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Yu-Chang Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03074838: Inflammatory Response to Aortic Valve Replacement
Official title: Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Cardiac surgery
TAVI
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2017-03-09
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
Primary purpose: TREATMENT

Brief summary: A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

Detailed description: 18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.

A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.

A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for aortic valve replacement without need for concurrent surgery

Exclusion Criteria:

* known inflammatory disease and anti-inflammatory treatment

Primary outcomes:
measure: Generation of several inflammatory markers measured through repeated blood samples
timeFrame: 24 hours
Secondary outcomes:
measure: Blood loss
timeFrame: 24 hrs
measure: Blood transfusion
timeFrame: 24 hrs
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital/University of Oslo
name: Erik Fosse, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Karoline KH Fiane, Med Student
role: STUDY_CHAIR
References:
citation: Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.
Clinical trial NCT01215838: MRI of the Liver With Eovist
Official title: Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Keywords: HCC
hepatocellular carcinoma
Eovist
MR
MRI
magnetic resonance
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2010-10-07
Enrollment: 4
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: Patients with known hepatocellular carcinoma undergoing MRI of the liver in the UWMC Radiology Clinic.

Brief summary: The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.

Detailed description: Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.

This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.

Eligibility criteria: Inclusion Criteria:

* known hepatocellular carcinoma
* undergoing MRI of the liver

Exclusion Criteria:

* Contraindication to MRI with IV contrast

Primary outcomes:
measure: Accuracy of a new MR protocol in diagnosing HCC and other liver lesions.
timeFrame: One day: participants will have one MRI of the liver.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Orpheus Kolokythas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
citation: Saito K, Kotake F, Ito N, Ozuki T, Mikami R, Abe K, Shimazaki Y. Gd-EOB-DTPA enhanced MRI for hepatocellular carcinoma: quantitative evaluation of tumor enhancement in hepatobiliary phase. Magn Reson Med Sci. 2005;4(1):1-9. doi: 10.2463/mrms.4.1.
citation: Frericks BB, Loddenkemper C, Huppertz A, Valdeig S, Stroux A, Seja M, Wolf KJ, Albrecht T. Qualitative and quantitative evaluation of hepatocellular carcinoma and cirrhotic liver enhancement using Gd-EOB-DTPA. AJR Am J Roentgenol. 2009 Oct;193(4):1053-60. doi: 10.2214/AJR.08.1946.
Clinical trial NCT06694038: Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
Official title: Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Biliary Obstruction Due to Common Bile Duct Stone
Malignant Bile Duct Obstruction
Keywords: jaundice
bile duct obstruction
abnormal liver enzymes
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 186
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: Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.


Eligibility criteria: Inclusion Criteria: older than 18 years of age -

Exclusion Criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy

-

Primary outcomes:
measure: post ERCP pancreatitis
timeFrame: within 48 hours of the procedure
Secondary outcomes:
measure: Bleeding
timeFrame: within 48 hours
measure: Perforation
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospial
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01430338: Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans
Official title: Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent 18FDG-PET/CT scan year between 2008-2010.

Brief summary: Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent 18FDG-PET/CT scan year between 2008-2010

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension
* Severe renal or hepatic disease

Primary outcomes:
measure: presence metabolic syndrome
timeFrame: 5 months
Secondary outcomes:
measure: BMI
timeFrame: 5 months
measure: visceral fat area
timeFrame: 5 months
measure: adipokines
timeFrame: 5 months
measure: sarcopenia
timeFrame: 5 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: korea University Guro Hospital
Study officials:
References:
Clinical trial NCT01598038: Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
Official title: Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: cancer
renal
Afinitor
pharmacokinetics
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
First posted: 2012-05-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 18 year-old.
2. Histologically documented renal cell carcinoma whatever the type.
3. One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted.
4. Patients with an indication to receive everolimus treatment
5. Patients able and willing to give written informed consent, before the first screening procedure.

Exclusion Criteria:

1. Patients currently receiving chemotherapy or immunotherapy
2. Prior treatment with temsirolimus
3. Contraindication in everolimus :

   * Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
   * Patients with severe hepatic impairment (Child-Pugh class C)
   * Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4. Pregnant or breastfeeding women
5. Patients unwilling to or unable to comply with the protocol.

Primary outcomes:
measure: Find a relationship between everolimus through blood level and treatment safety.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre François Baclesse
name: SEVIN Emmanuel, MD
role: PRINCIPAL_INVESTIGATOR
References: