louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06555510: Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications
Official title: Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications Regardless of the Underlying Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Who Underwent Hepatectomy for Liver Neoplasms
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 414
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We prospectively reviewed consecutive patients who underwent hepatectomy at the Kochi Health Sciences Center. Patients who underwent hepatectomy, regardless of the underlying disease, between March 2018 and December 2022 were eligible for the study. Patients who did not undergo preoperative BIA were excluded. Those who underwent repeat hepatectomies were included; however, if they underwent more than two hepatectomies in the study period, only the clinical features during the first hepatectomy period were included and those during the second or third hepatectomy period were excluded.

Brief summary: Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.

Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of liver neoplasms

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

Primary outcomes:
measure: incidence of post-hepatectomy complications
timeFrame: incidence of post-hepatectomy complications
Secondary outcomes:
Other outcomes:
Locations:
city: Kochi
country: Japan
facility: Takehiro Okabayashi
Study officials:
References:
Clinical trial NCT05047510: GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma
Official title: An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma.

The main purposes of this study include:

① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore.

② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with hepatocellular carcinoma.
2. Planned to receive hepatectomy.
3. Liver function Child-Pugh A/B.
4. GPC-3 was validated highly expressed preoperatively.
5. Aged 18 to 75, and the expected lifetime is longer than 6 months.
6. Approved to sign the informed consent.

Exclusion Criteria:

1. Allergic to IRDye800.
2. Enrolled in other trials in the past 3 months.
3. Another malignant tumor was found.
4. Undesirable function of heart, lung, kidney, or any other organs.
5. Unable to tolerate a hepatectomy.
6. The researchers considered inappropriate to be included.

Primary outcomes:
measure: HCC lesions
timeFrame: During hepatocellular resection surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
References:
Clinical trial NCT00780910: Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
Official title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Relapsed After Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-10-28
Enrollment: 109
Sex: ALL
Minimum age (years): 20
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 study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.


Eligibility criteria: Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayashi N, Okanoue T, Tsubouchi H, Toyota J, Chayama K, Kumada H. Efficacy and safety of telaprevir, a new protease inhibitor, for difficult-to-treat patients with genotype 1 chronic hepatitis C. J Viral Hepat. 2012 Feb;19(2):e134-42. doi: 10.1111/j.1365-2893.2011.01528.x. Epub 2011 Nov 8.
Clinical trial NCT01111110: Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Official title: Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2010-04-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years.
* Physician diagnosis of asthma.
* FEV1 60-80% predicted during the day.
* FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.
* No smoking in the previous year and \< 10-pack year history.
* No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.

Exclusion Criteria:

* Patient required a short course of oral steroid in the past 30 days.
* Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.
* History of viral respiratory tract infection in the 3 weeks prior to the screening visit.
* Positive pregnancy test.

Primary outcomes:
measure: Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
timeFrame: fifteen minutes after 1 puff of albuterol
measure: Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
timeFrame: 15 minutes after 2 puffs of albuterol
measure: Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
timeFrame: fifteen minutes after 4 puffs of albuterol
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT04657510: Femoral frACturEs and COVID-19.
Official title: Femoral frACturEs and COVID-19. Retrospective Comparative Cohort Study on the Early Prognosis of Patients Affected by Proximal Femur Fractures and COVID-19.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Femur Fracture
Fragility Fracture
Keywords: proximal femur fracture
fragility fracture
Covid-19
SARS-CoV2
FACE-COVID 19
prognosis
cohort study
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 140
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with \>45 years of age admitted to our center from march 2020 to april 2020 for proximal femur fracture and tested for SARS-CoV-2.

Brief summary: Retrospective cohort study comparing the early prognosis after surgically-treated proximal femur fragility fractures in patients affected and not affected by COVID-19.


Eligibility criteria: Inclusion Criteria:

* Age ≥45 years
* Admitted to IRCCS Orthopaedic Institute Galeazzi for proximal femur fractures from march 2020 to april 2020.
* Tested for COVID-19 through naso-pharyngeal swab analized with RT-PCR

Exclusion Criteria:

* Age \<45 years
* Not tested for SARS-CoV-2
* Other fractures (including bilateral proximal femur fractures)

Primary outcomes:
measure: Survival at discharge day (comparison between the two groups)
timeFrame: on discharge day, on average after 1 week
Secondary outcomes:
measure: Length of stay (comparison between the two groups)
timeFrame: on discharge day, on average 1 week
measure: Readmission rate (comparison between the two groups)
timeFrame: up to 30 days after discharge
measure: Complications rate (comparison between the two groups)
timeFrame: up to 30 days after discharge
measure: Survival at 30 days after discharge (comparison between the two groups)
timeFrame: 30 days after discharge
measure: Routine lab exams values (comparison between the two groups)
timeFrame: At admission, 1st postoperative day, 5th postoperative day, on discharge day
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Giuseppe M Peretti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104610: Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome
Official title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: Breas Medical S.A.R.L.
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

Detailed description: Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.

Eligibility criteria: Inclusion Criteria:

* Patients from 20 to 75 years old.
* Body mass index \> 32 kg/m2
* Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
* PaCO2 \> 5,9 kPa in diurnal, spontaneous ventilation

Exclusion Criteria:

* Patients with COPD and VEMS/FVC \< 65%
* Patients with CHF and periodic breathing (Ejection Fraction \<40%)
* Patients with a recent respiratory decompensation in the month preceding inclusion

Primary outcomes:
measure: Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
timeFrame: 6 weeks
Secondary outcomes:
measure: Evolution in dyspnea scores (BDI/TDI and Simon Score)
timeFrame: 6 weeks
measure: Evolution of subjective and objective sleepness (Osler)
timeFrame: 6 weeks
measure: Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
timeFrame: 6 weeks
measure: Evolution of blood inflammation (IL6, TNFα et CRP)
timeFrame: 6 weeks
measure: Evolution of insulin résistance
timeFrame: 6 weeks
measure: Compliance (hours of treatment)
timeFrame: 6 weeks
measure: Evolution of quality of ventilation (Leaks, asynchronism, others events)
timeFrame: 6 weeks
measure: Sleep quality (PSG) between the 3 groups at 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU
city: Paris cedex 13
country: France
facility: GH Pitié-Salpétrière - Service de pneumologie et réanimation
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis Pepin, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03070210: Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
Official title: A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis, Chronic
Abdominal Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB).

METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.

Detailed description: Inclusion criteria include: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.

Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or "caine" anesthetics.

Eligibility criteria: Inclusion Criteria:

* patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.

Exclusion Criteria:

* pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or "caine" anesthetics.

Primary outcomes:
measure: Pain relief
timeFrame: 1 week
Secondary outcomes:
measure: Complete response rate
timeFrame: 1 week
measure: Duration of pain relief
timeFrame: up to 2 months
measure: Opioid consumption
timeFrame: up to 2 months
measure: Adverse effects
timeFrame: in up to 2 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Tyler Stevens, MD
role: STUDY_DIRECTOR
References:
citation: Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.
citation: Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.
Clinical trial NCT02897310: Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy
Official title: Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Acute Kidney Injury
Keywords: critically ill patients
acute kidney injury
renal replacement therapy
long term outcome
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults hospitalised in intensive care and who developped acute renal failure requiring renal replacement therapy

Brief summary: This study assess the vital status, renal function and renal recovery of patients admitted to intensive care unit and requiring renal replacement therapy for acute kidney failure. Patient follow up is up to 3 years after ICU admission when possible.

Detailed description: Up to 50% of critically ill patients develop acute kidney injury and up to 10% require renal replacement therapy in the intensive care unit. This study aims to identify factors associated with mortality and to evaluate renal recovery of patients who had acute kidney failure requiring renal replacement therapy in intensive care unit at 1 and 3 years post intensive care unit admission.

Eligibility criteria: Inclusion Criteria:

* Adults admitted to the intensive care
* Acute kidney failure requiring renal replacement therapy

Exclusion Criteria:

* Patients suffering end stage renal failure requiring chronic renal replacement therapy
* Patients under 18 years

Primary outcomes:
measure: one-year mortality
timeFrame: year 1
Secondary outcomes:
measure: hospital mortality
timeFrame: year 1
measure: one year renal function
timeFrame: Year one
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Aubron Cécile
role: STUDY_DIRECTOR
References:
Clinical trial NCT02790710: Brief Intervention for OCD Fears
Official title: Brief Intervention for OCD Fears
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obsessive-compulsive Disorder
Keywords: propanolol
obsessive-compulsive disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study will test the efficacy of propranolol or placebo, administered after reactivation of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and avoidance in OCD.

Detailed description: Twenty subjects with OCD will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear reactivation procedure. Primary outcome assessment will be OCD symptoms and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention

Eligibility criteria: Inclusion Criteria:

* Principal Diagnosis of Obsessive-Compulsive Disorder

Exclusion Criteria:

* History of other serious psychiatric disorder
* Current Major Depressive Disorder
* Women who are pregnant or nursing
* Current use of psychiatric medication
* Persons planning to start another treatment during the study period
* Any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol

Primary outcomes:
measure: Yale Brown Obsessive-Compulsive Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Behavioral Avoidance Task
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Blair Simpson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02491710: Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basic Laparoscopic Skills Training
Keywords: Surgical education
Laparoscopy
Laparoscopic suturing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Training is of great importance in laparoscopy. There are different commercially available trainers which are quite expensive and are used by trainees only inside the hospital.

The aim of this study is to find out whether basic laparoscopic skills training using an inexpensive tablet-based laparoscopic box trainer leads to equal training results (= improvement of skills) compared to practicing with a conventional commercial box trainer. Furthermore, trainee satisfaction with this home-made alternative compared to the standard trainer will be assessed.


Eligibility criteria: Inclusion Criteria:

* Medical students of the Medical University of Vienna

Exclusion Criteria:

* Extensive experience with laparoscopic box trainers or laparoscopic surgery

Primary outcomes:
measure: Fundamentals of Laparoscopy (FLS) manual Skills Score
timeFrame: After completion of training (4-6 weeks)
Secondary outcomes:
measure: Trainee satisfaction with the two different training devices
timeFrame: After completion of training (4-6 weeks)
Other outcomes:
Locations:
Study officials:
References: