louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02351219: FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer
Official title: Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Carcinoma Stage III
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.

After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.

In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.

Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.

Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.


Eligibility criteria: Inclusion Criteria:

* Stage III unresectable pancreatic cancer defined for:

  * extended encasement of superior mesenteric artery or celiac axis/hepatic artery
  * both arterial and venous (portal vein/superior mesenteric vein) encasement
  * unreconstructible vessel encasement
* ECOG Performance Status 0-1
* Age 18-75
* Adequate liver, renal and bone marrow function

Exclusion Criteria:

* Evidence of distant metastases
* Cardiovascular diseases
* Contraindications to studied drugs

Primary outcomes:
measure: Radical resection rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: Within 24 months
Other outcomes:
measure: Overall survival
timeFrame: Within 36 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: within all the treatment period
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
References:
Clinical trial NCT04788719: Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods
Official title: Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Analysis
Hip Arthritis
Total Hip Arthroplasty
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

Detailed description: The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Patients with radiological signs of osteoarthritis of the hip, hip pain and functional disability may be treated with insertion of a THA.

Two different fixation methods are used in order to insert THR implants. Cemented fixation using bone cement, polymethyl methacrylate (PMMA) is the most commonly used fixation method in Sweden. A new bone cement, Refobacin®, already marketed in Germany is planned to be introduced in Sweden in late 2018.

The hospital is also equipped with a modern gait laboratory were the functional gait performance can be evaluated. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. The subjects will undergo gait analysis befor and 2 year after surgery.

Eligibility criteria: Inclusion Criteria:

* hip arthritis

Exclusion Criteria:

* no hip arthritis

Primary outcomes:
measure: Kinematics
timeFrame: Preop
measure: Kinematics
timeFrame: Postop 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Roland Zügner
Study officials:
affiliation: Göteborg University
name: Roland Zügner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147219: Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults
Official title: Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tibial Shaft Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways


Eligibility criteria: Inclusion Criteria:

* adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage

Exclusion Criteria:

* patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity

Primary outcomes:
measure: Primary Dynamization Interlocking Intramedullary Tibial Nail
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, Schemitsch EH. Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma. 2010 Mar;68(3):629-32. doi: 10.1097/TA.0b013e3181a7c16d.
citation: Fracture and dislocation compendium. Orthopaedic Trauma Association Committee for Coding and Classification. J Orthop Trauma. 1996;10 Suppl 1:v-ix, 1-154. No abstract available.
citation: Omerovic D, Lazovic F, Hadzimehmedagic A. Static or dynamic intramedullary nailing of femur and tibia. Med Arch. 2015 Apr;69(2):110-3. doi: 10.5455/medarh.2015.69.110-113. Epub 2015 Apr 6.
citation: Vaughn J, Gotha H, Cohen E, Fantry AJ, Feller RJ, Van Meter J, Hayda R, Born CT. Nail Dynamization for Delayed Union and Nonunion in Femur and Tibia Fractures. Orthopedics. 2016 Nov 1;39(6):e1117-e1123. doi: 10.3928/01477447-20160819-01. Epub 2016 Aug 30.
Clinical trial NCT06333119: The Relationship Between Urinary Incontinence and Motor Symptoms
Official title: The Relationship Between Urinary Incontinence and Motor Symptoms in Individuals With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Urinary Incontinence
Motor Skills Disorders
Keywords: stroke
urinary incontinence
spasticity
balance
gait
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 46
Sex: ALL
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: individuals with stroke

Brief summary: There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke.

Detailed description: Evaluation parameters used in the study:

Modified Rankin Score 24 hours pad test Tinetti Balance and Gait Scale Modified Ashworth scale Danish Prostatic Symptom Score

Eligibility criteria: Inclusion Criteria:

* Being 18 years old, having a stroke history of at least 3 months, having had only one stroke, scoring between 0-2 points according to MRS, being able to stand and walk independently or with a walking aid, being able to speak Turkish.

Exclusion Criteria:

* Those with incomprehensible speech disorders,
* Those who have additional neurological diseases other than stroke,
* orthopedic, cardiovascular, etc., which may cause balance disorders. those with illnesses,
* those who are pregnant,
* Those with vision and hearing loss

Primary outcomes:
measure: relationship with between urinary incontinence and motor symptoms
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University
name: Pinar Yasar
role: STUDY_DIRECTOR
References:
Clinical trial NCT06554119: Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery
Official title: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Valve Regurgitation; Complications, Longterm Outcome
Keywords: tricuspid valve regurgitation; technique advances; complications
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 375
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery

Brief summary: This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.


Eligibility criteria: Inclusion Criteria:patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery

Exclusion Criteria: age \<16，severe tricuspid regurgitation secondary to primary pulmonary hypertension, and those with substantial missing case data.

Primary outcomes:
measure: death rate
timeFrame: 1999-01 - 2025-01
measure: complications
timeFrame: 1999-01 - 2025-01
Secondary outcomes:
measure: redo of tricuspid valve
timeFrame: 1999-01 - 2025-01
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Huanlei Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT06030219: Microbiome Effect of Omadacycline on Healthy Volunteers
Official title: Microbiome Effect of Omadacycline on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: omadacycline
microbiome
healthy volunteer
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Paratek Pharmaceuticals Inc
First posted: 2023-09-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.


Eligibility criteria: Inclusion. All volunteers will be considered healthy based on medical history

Exclusion. Patients will be excluded if they report any of the following:

* Cardiovascular disease
* Gastrointestinal disease
* Hepatic or renal disease
* Receipt of an antibiotic for at least three months prior to enrollment.
* Receipt of a probiotic for at least a month prior to enrollment and during the entire study period.

Primary outcomes:
measure: Microbiome changes
timeFrame: During dosing and 30 day follow up period
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: Professor and Chair
name: Kevin W Garey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06573619: Therapeutic Adherence in Patients With Chronic Diseases
Official title: Therapeutic Adherence in Patients With Chronic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic diseases

Brief summary: Objectives of the study are:

* The validation of the GMAS questionnaire in patients with chronic disease.
* Measurement of the level of therapeutic adherence in patients with chronic illness.
* Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.

Detailed description: The research is multicentre and will be conducted at the Fondazione Policlinico Gemelli IRCCS in Rome as reference centre together with the other participating centres. Patients will be enrolled at the centres involved, either during visits or during their hospital stay.

Eligibility criteria: Inclusion Criteria:

* Chronically ill;
* Age 18 years or older;
* Willingness to participate in the study;
* Chronic illness diagnosed at least 3 months before the start of the study;
* Reading and signing the informed consent.

Exclusion Criteria:

* Reduced command of the Italian language;
* Subjects suffering from severe psychiatric disorders;
* Serious clinical conditions that do not permit completion of the questionnaire;
* Refusal to sign the informed consent to participate in the study.

Primary outcomes:
measure: The validation of the GMAS questionnaire in patients with chronic disease.
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of the level of therapeutic adherence in patients with chronic illness. Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Daniele Napolitano
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Daniele Napolitano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280019: FRC Guided Therapy in Acute Respiratory Failure
Official title: Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanical Ventilation
Acute Respiratory Failure
Cardiac Surgery
Keywords: functional residual capacity
electrical impedance tomography
inflammatory parameters
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2011-01-20
Enrollment: 20
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: In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* need for mechanical ventilation due to respiratory failure after cardiac surgery

Exclusion Criteria:

* circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support

Primary outcomes:
measure: Regional ventilation
timeFrame: 6 hours
Secondary outcomes:
measure: arterial oxygenation and inflammation
timeFrame: 6 hours
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Department of Anaesthesiology, Intensive Care Unit, University of Lübeck
Study officials:
References:
Clinical trial NCT06615219: Intergroup Contact Intervention for Nursing Undergraduates to Improve Aging Stereotype
Official title: Effects of Intergroup Contact Training on Aging Stereotypes in Undergraduate Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Ageism
Lead sponsor: Huzhou University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to investigate the effects of intergroup contact training on the levels of aging stereotypes, intergroup anxiety, and willingness to engage in geriatric nursing work among undergraduate nursing students.

Detailed description: This research was designed as a pre-test-post-test randomized controlled experimental study. Nursing students from a university in Hangzhou, China served as the research subjects, who were randomly assigned to the experimental or control group. The control group received training in the regular course and was given compensatory intervention after the experiment, while the experimental group received intergroup contact training (the regular course combined with intergroup contact content). Such training was carried out in the forms of both individual and group interventions for a duration of 12 weeks. The levels of aging stereotypes, intergroup anxiety, and the willingness to engage in geriatric nursing among the nursing students were investigated before and after the training. Number, percentage, mean, standard deviation, Shapiro-Wilk, T-test, Wilcoxon signed ranks tests, and Mann-Whitney U tests were used to analyze the data.

Eligibility criteria: Inclusion Criteria:

* full-time undergraduate students enrolled in the nursing program
* not yet enrolled in a geriatric nursing course
* agreed to participate in this study and signed an informed consent form

Exclusion Criteria:

* students in the nursing program pursuing a bachelor degree through a vocational-to-degree pathway
* Students who have taken a break from their studies

Primary outcomes:
measure: The implicit effect value (D)
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Geriatric Nursing Willingness Scale
timeFrame: Baseline and Month 3
measure: Intergroup Anxiety Scale (IAS)
timeFrame: Baseline and Month 3
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: School of Nursing, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: Huzhou University
name: Meijuan Cao
role: STUDY_CHAIR
References:
Clinical trial NCT01438918: X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee
Official title: A Long-term, Confirmatory, Phase 3, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Investigate The Safety And Efficacy Of Orally Administered Sd-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
X-ray
Joint Space Narrowing
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility criteria: Inclusion Criteria:

Subjects aged \>= 40 years Diagnosed with knee OA (ACR definition of OA) Radiographic evidence of OA in the study knee

Exclusion Criteria:

A diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters

Primary outcomes:
measure: To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period
timeFrame: 24 months
Secondary outcomes:
measure: Clinical benefit of SD 6010 will be measured from changes in response from baseline to 24 months in 7 patient reported outcomes (PRO), including, but not limited to, WOMAC, pain VAS, ICOAP, KOOS.
timeFrame: 24 months
measure: Total analgesic medication burden for OA in the study knee will be compared back to baseline of an increased, sustained use of standard background and/or rescue medication for more than 30 days as measured at the Month 12 and 24 visits
timeFrame: 24 months
measure: Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed
timeFrame: 24 months
measure: Safety: Change from baseline to M24 in ECG abnormalities
timeFrame: 24 months
measure: Safety: In a subset of subjects: Change from baseline on average as assessed by 24-h ambulatory blood pressure monitoring (ABPM) at months 3 and 6
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: