louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03700346: Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients
Official title: Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

Detailed description: Microcirculatory alterations are frequently observed in patients with sepsis. In vivo microdialysis (MD) is a bedside technique that can monitor tissue metabolic changes. We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline and every 6 hours for 3 days by using muscle microdialysis. Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values. A positive value of clearance means a decrease in the rate of the parameter under study.

Eligibility criteria: Inclusion Criteria:

* patients fulfilled the criteria of septic shock

Exclusion Criteria:

* pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
* incomplete data

Primary outcomes:
measure: Clearances of muscle lactate, and L/P ratio
timeFrame: 3 days
Secondary outcomes:
measure: muscle lactate
timeFrame: 3 days
measure: muscle pyruvate
timeFrame: 3 days
measure: muscle glucose
timeFrame: 3 days
measure: muscle glycerol
timeFrame: 3 days
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military hospital of tunis
state: Mont Fleury
city: Tunis
country: Tunisia
facility: Military Hopital of Tunis
Study officials:
affiliation: Military hospital
name: zied Hajjej, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370146: Motor Imagery and Rehabilitation of Orthopaedic Patients
Official title: Can Mental Training Based on Motor Imagery Speed up the Rehabilitation of Walking? Efficacy of a Controlled Procedure and Neurofunctional Bases of Recovery in Patients With Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experimental group (MI training): 24 candidates to TKA (aged between 45 and 65 years) will undergo a specific MI training during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation.

Control group 1 (non-specific cognitive training): 24 candidates to TKA will undergo a non-specific cognitive treatment during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation.

Control group 2: 48 subjects with similar demographic characteristics to those of the previous two groups will be evaluated with the same cognitive/fMRI paradigm to assess in TKA candidates the presence of anomalies of cortical organization of the motor system in the pre-surgical phase.

Brief summary: Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.


Eligibility criteria: Inclusion Criteria:

* Right handed
* No contraindication to the fMRI exam

Exclusion Criteria:

* Contraindication to the fMRI exam

Primary outcomes:
measure: Speed of walking
timeFrame: 20 days
measure: BOLD (blood oxygen level-dependent) activity
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT00969046: Dose-Escalation Study in Advanced Colon Cancer Patients
Official title: EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Keywords: Colon cancer
MTD
DLT
EPO906
patupilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 60
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: This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
2. Age ≥ 18 years
3. Life expectancy ≥ 12 weeks
4. WHO performance status of 0-1
5. Negative serum pregnancy test
6. Adequate hepatic or renal function and hematological parameters

Exclusion Criteria:

1. Brain metastases
2. Ileostomy or colonostomy
3. History of pelvic radiotherapy
4. Grade \> 1 diarrhea at baseline

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To identifymaximum tolerated dose (MTD)
timeFrame: During cycle 1 and 2 (approx 6 to 8 wks)
Secondary outcomes:
measure: To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams
timeFrame: at base line, every 3 weeks prior to start of the next dose, at end of treatment
measure: To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])
timeFrame: at baseline and every 8 wks
measure: To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration
timeFrame: Cycle 1 and 4
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: Novartis Investigative Site
city: Prague
country: Czechia
facility: Novartis Investigative Site
city: Saint-Herblain Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Royal London Hospital
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01950546: Nanosilver Fluoride to Prevent Dental Biofilms Growth
Official title: Nanosilver Fluoride: a Microbiological and Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: silver nanoparticles
antimicrobial activity
toxicity
biofilm
cariostatic agents
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of S. mutans present in dental plaque of children.

Detailed description: The product will be apllied on cervical vestibular surfaces of incisors and canines healthy, with a total of 8 teeth, 4 upper and 4 below. Children will be instructed not to ingest any liquid or food within two hours after application. After a period of 7 days will be carried biofilm colect of cervical dental surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas. This material will be packaged in pre-weighed microfuge tubes containing 1.5 ml of buffered saline solution (0.9% sodium chloride), and transported under refrigeration immediately to the laboratory where analysis will be performed and the S. mutans colonies will be counted. The biofilm collect and posterior laboratorial analysis will be performed weekly.

Eligibility criteria: Inclusion Criteria:

* Have at least 4 upper teeth and 4 lower teeth deciduous;systemic health satisfactory; did not use antibiotics or nonsteroidal anti-inflammatory within one month before or during the study;do not use any other forms of chemical control of biofilm during the study period;not being a user of orthodontic devices or dentures;

Exclusion Criteria:

* Presenting oral lesions, supragingival calculus and severe malocclusion.

Primary outcomes:
measure: Initial biofilm collecting before applying the product and after nanosilver fluoride application.
timeFrame: one week
Secondary outcomes:
measure: Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilm
timeFrame: two weeks
Other outcomes:
measure: Collection of dental biofilm will after four weeks of product application.
timeFrame: Four weeks
measure: Collection of dental biofilm after eight weeks of product application
timeFrame: Eight weeks
Locations:
city: João Pessoa
country: Brazil
facility: Escola Municipal Anita Trigueiro do Valle
state: Paraíba
Study officials:
affiliation: UPE
name: Aronita Rosenblatt, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06074146: Outcomes After Epigastric Hernia Repair in Women.
Official title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epigastric Hernia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 3031
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females in Denmark undergoing epigastric hernia repair

Brief summary: Nationwide cohort study on women undergoing epigastric hernia repair

Detailed description: Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias.

The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.

Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. A 100% follow-up was obtained by combining data from the National Civil Register. The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.

Eligibility criteria: Inclusion Criteria:

* females undergoing epigastric hernia repair in Denmark

Exclusion Criteria:

* emergency repair umbilical hernias incisional hernias males

Primary outcomes:
measure: hernia recurrence
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Mette Willaume
Study officials:
References:
Clinical trial NCT01477346: Arthritis Research UK Gout Treatment Trial - Phase 2
Official title: Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Arthritis Research UK
First posted: 2011-11-22
Enrollment: 517
Sex: ALL
Minimum age (years): 21
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 determine in community-derived patients with gout the effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects recommended best practice (including patient information concerning gout, its prognosis and its non-pharmacological and drug options).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of gout
* At least one acute attack of gout within previous 12 months

Exclusion Criteria:

- Inability to give informed consent and known terminal or mental illness

Primary outcomes:
measure: Reduction in serum uric acid levels
timeFrame: 2 years
Secondary outcomes:
measure: Reduction in number of self reported acute attacks during year 2
timeFrame: 2 years
measure: Improved Quality of Life scores at study end
timeFrame: 2 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Academic Rheumatology, University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Michael Doherty, MA MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, Barclay C, Doherty S, Duley L, Hatton R, Rees F, Stevenson M, Zhang W. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1403-1412. doi: 10.1016/S0140-6736(18)32158-5.
Clinical trial NCT02742246: Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders
Official title: Efficacy and Mechanisms of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-04-18
Enrollment: 99
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: Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use

Detailed description: Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.

Eligibility criteria: Inclusion Criteria:

Individuals will be included who:

* Are 18 years of age or older.
* Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
* Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
* Are willing to provide locator information for follow-up, and
* Are fluent in English and have a 6th grade or higher reading level.

Exclusion Criteria:

Individuals will be excluded who:

* Have an untreated bipolar or schizophrenic disorder,
* Have a current legal case pending such that incarceration during the 8-week protocol is likely,
* Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
* Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).

Primary outcomes:
measure: Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
timeFrame: Baseline up to 8 weeks
measure: Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
timeFrame: from end of treatment at week 8 up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: MCCA
state: Connecticut
city: New Haven
country: United States
facility: SATU
state: Connecticut
Study officials:
affiliation: Yale University
name: Brian Kiluk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058746: Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
Official title: A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: pancreas
surgery
Pancreaticoduodenectomy
Central Pancreatectomy
Distal Pancreatectomy
resection
IV fluids
09-185
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 331
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 is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.

Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.

This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Adults \> or = 18 years
* Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.

Exclusion Criteria:

* Pregnancy
* History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation
* MI within 3 months
* History of stroke
* History of congestive heart failure and ejection fraction less than 35%
* History of severe COPD and resting oxygen saturation (SpO2) \< 90%
* Renal dysfunction (Cr \> 1.8)
* Abnormal coagulation parameters (INR \> 1.5 not on Coumadin, or platelet
* Presence of active infection including HIV
* BMI \> 35
* American Society of Anesthesiologists Status \> III, assigned at time of preoperative visit
* Corticosteroid use \> 10 mg Prednisone/day
* Bilirubin \> 10.0

Primary outcomes:
measure: To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.
timeFrame: 3 years
Secondary outcomes:
measure: Determine if restrictive perioperative fluid management, comp to liberal periop fluid management, decreases delayed gastric emptying, length of stay (LOS) & the incidence of other, less frequent morbidity in adult patients getting pancreatic resection.
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Florence Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: