louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00610701: Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Official title: Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fractures, Closed
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 35
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 evaluate patients with tibial plateau fractures.

Detailed description: The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.

Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and above (adult population)
* All open and closed tibial plateau fractures

Exclusion Criteria:

* 17 years of age and less (pediatric population)
* Quadriplegic patients
* Vascular Injury to Extremity
* Ipsilateral femur fractures
* Ipsilateral Hip fractures

Primary outcomes:
measure: Quadriceps Strength
timeFrame: (admission, 6 weeks, 3 months, 6 months) 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Brett Crist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069601: H1N1sw Vaccine in Adult Transplant Recipients
Official title: A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Immunocompromised
Keywords: solid organ transplantation
bone marrow transplantation
adults
adults with solid organ transplantation
adults with bone marrow transplantation
Lead sponsor: HepNet Study House, German Liverfoundation
Sponsor class: NETWORK
First posted: 2010-02-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.


Eligibility criteria: Inclusion Criteria:

* Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
* Patients able to visit the outpatient clinic with a life expectancy of at least one year
* Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Exclusion Criteria:

* Individuals who received any vaccine within 30 days prior to study entry
* Individuals who received a H1N1 vaccination less than 6 months prior to the study
* Influenza diagnosed by a physician within 4 months prior to the study start
* Pregnant or lactating females
* History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)

Primary outcomes:
measure: The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.
timeFrame: 42 days
Secondary outcomes:
measure: The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration.
timeFrame: 42 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Michael P Manns, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02846701: Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain
Official title: DULOPLASM Study: Pilot Study on Mechanisms of Analgesic Action of Duloxetine: Effective Dosage of Duloxetine at the Peak and at the Lowest Plasma Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
Antidepressant
Duloxetine
Liquid Chromatography
Mass Spectrometry
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie before the daily taking dose of duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment.

The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6 hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment.

Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the degree of pain relief and to evaluate the sensation of the global improvement experienced by the patient.


Eligibility criteria: Inclusion criteria:

* aged 40 to 75 years old
* relieved of their neuropathic pain by 60 mg of duloxetine treatment (with a differential of\> 30% in the intensity of neuropathic pain with NRS, before and after treatment initiation)

Exclusion criteria:

* concomitant treatment with enoxacin, fluvoxamine, flecainide, propafenone, metoprolol, risperidone, verapamil, omeprazole, modafinil, mequitazine, propafenone, tamoxifen, Monoamine Oxidase Inhibitors.

Primary outcomes:
measure: Measurement of the lowest plasma concentration of duloxetine in pmol/mL.
timeFrame: The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample taken at the inclusion visit (V0), before the daily morning dose of duloxetine.
Secondary outcomes:
measure: Measurement of the plasma concentration peak of duloxetine in pmol/mL.
timeFrame: The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample taken during the V1 visit (28 days after V0, 6 hours after the daily morning dose of duloxetine).
Other outcomes:
measure: Intensity of his pain assessed by Numeric Rating Scale (NRS) in 11 points.
timeFrame: at inclusion visit V0 and at V1 visit (28 days after the inclusion visit V0).
measure: Sensation of improvement
timeFrame: at inclusion (V0 visit)
Locations:
Study officials:
References:
Clinical trial NCT05093101: The Prognostic Value of Serum Biomarkers in Osteosarcoma
Official title: The Prognostic Value of Serum Biomarkers in Osteosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pazients with osteosarcoma from 01-01-2000 to 31-12-2020

Brief summary: Observational retrospective cohort study using laboratory data of blood tests prior to surgical and chemotherapy treatment and other histologic, clinical, and instrumental data related to patient history from digitized medical records and analysis of the same as predictors of outcomes.


Eligibility criteria: Inclusion Criteria:

* Osteosarcoma diagnosed at the Pathological Anatomy of the Rizzoli Orthopaedic Institute in Bologna;
* Minimum 2-year follow-up period;
* Medical records, complete blood work and instrumental examinations, regular follow-up;
* Patients with age ≥ 2 years;

Exclusion Criteria:

* Patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our Institute

Primary outcomes:
measure: Evaluation of 5-year survival
timeFrame: 5 years
Secondary outcomes:
measure: Evaluation of the rate of local recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Nakamura T, Grimer RJ, Gaston CL, Watanuki M, Sudo A, Jeys L. The prognostic value of the serum level of C-reactive protein for the survival of patients with a primary sarcoma of bone. Bone Joint J. 2013 Mar;95-B(3):411-8. doi: 10.1302/0301-620X.95B3.30344.
citation: Li YJ, Yang X, Zhang WB, Yi C, Wang F, Li P. Clinical implications of six inflammatory biomarkers as prognostic indicators in Ewing sarcoma. Cancer Manag Res. 2017 Sep 28;9:443-451. doi: 10.2147/CMAR.S146827. eCollection 2017.
citation: Aggerholm-Pedersen N, Maretty-Kongstad K, Keller J, Baerentzen S, Safwat A. The Prognostic Value of Serum Biomarkers in Localized Bone Sarcoma. Transl Oncol. 2016 Aug;9(4):322-8. doi: 10.1016/j.tranon.2016.05.006.
Clinical trial NCT02673801: Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic
Official title: OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Referral and Consultation
Orthopedics
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis

Brief summary: The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. This will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.

Detailed description: Further description is provided as eligibility criteria and outcome measures.

Eligibility criteria: Inclusion Criteria:

* All patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis.

Exclusion Criteria:

* Cognitive or language problems that precludes the filling in of the questionnaires
* Unwillingness to answer the questionnaires
* Patients with rheumatoid arthritis, neurological diseases or cancer

Primary outcomes:
measure: "Relevant" or "Not relevant" for orthopedic assessment
timeFrame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Secondary outcomes:
measure: Knee Injury an Osteoarhtritis Outcome Score (KOOS)
timeFrame: At baseline
Other outcomes:
measure: Kellgren-Lawrence scale
timeFrame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
measure: Treatment plan
timeFrame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
measure: Earlier treatment
timeFrame: At baseline
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Research physiotherapist
name: Lone R Mikkelsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03485001: Treatment of Primary Type I Pterygia With Argon Laser
Official title: Treatment of Primary Type I Pterygia With Argon Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Introduction: Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

Objectives: To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Detailed description: Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Eligibility criteria: Inclusion Criteria:

* Patients who had had symmetric type I pterygia in both eyes
* Assessments for the 6 month follow-up period after argon laser treatment

Exclusion Criteria:

* Patients with diabetes Mellitus, collagenopathies, previous ocular surgeries, and pregnant patients

Primary outcomes:
measure: Pterygia measurements
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología
Study officials:
References:
citation: Welch MN, Reilly CD, Kalwerisky K, Johnson A, Waller SG. Pterygia measurements are more accurate with anterior segment optical coherence tomography - a pilot study. Nepal J Ophthalmol. 2011 Jan-Jun;3(1):9-12. doi: 10.3126/nepjoph.v3i1.4271.
citation: Nava-Castaneda A, Tovilla-Canales JL, Rodriguez L, Tovilla Y Pomar JL, Jones CE. Effects of lacrimal occlusion with collagen and silicone plugs on patients with conjunctivitis associated with dry eye. Cornea. 2003 Jan;22(1):10-4. doi: 10.1097/00003226-200301000-00003.
Clinical trial NCT02113501: Optimized Treatment Strategy for HighGrade1 (HGT1) Bladder Cancer Based on Substaging: a Prospective Observational Cohort Study
Official title: Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: HGT1
high risk bladder cancer
substaging
repeat transurethral resection (reTUR)
lamina propria
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 200
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: Initial HGT1 bladder cancer patients that have undergone a complete TUR and are willing to enter the protocol.

Brief summary: Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. The main hypothesis is that HighGradeT1a bladder cancer can spare a second endoscopic procedure.

Detailed description: Only cases of initial diagnosis of HighGradeT1 and with a complete transurethral endoscopic resection (TUR) of bladder tumor) can enter this protocol. HighGradeT1a will only receive standard BCG treatment (induction and maintenance). HighGradeT1b will undergo a second transurethral endoscopic resection (TUR) after the induction of Bacillus de Calmette-Guerin (BCG) and then continue mantenaince BCG and standard follow-up.

Eligibility criteria: Inclusion Criteria:

* HGT1 bladder cancer at initial diagnosis and after a complete TUR

Exclusion Criteria:

* abscence of muscularis propria in the TUR specimen

Primary outcomes:
measure: progression
timeFrame: 5year
Secondary outcomes:
measure: recurrence
timeFrame: 5year
Other outcomes:
measure: Cancer specific survival
timeFrame: 5year
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron, Barcelona, Spain
Study officials:
affiliation: Hospital Vall d'Hebron, Barcelona, Spain
name: Anna Orsola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orsola A, Cecchini L, Raventos CX, Trilla E, Planas J, Landolfi S, de Torres I, Morote J. Risk factors for positive findings in patients with high-grade T1 bladder cancer treated with transurethral resection of bladder tumour (TUR) and bacille Calmette-Guerin therapy and the decision for a repeat TUR. BJU Int. 2010 Jan;105(2):202-7. doi: 10.1111/j.1464-410X.2009.08694.x. Epub 2009 Jun 24.
Clinical trial NCT05506501: Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction
Official title: Comparative Study Between Intentional Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction Undergoing Insertion of Nail Tibia for Fixation of Fracture Shaft Tibia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Ejection Fraction Patients
Fracture Tibia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

Detailed description: Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 years old.
* Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
* Patients with low ejection fraction (30-40%).

Exclusion Criteria:

* Patient refusal
* Uncooperative patient
* Unconscious patients
* Cases with head trauma
* History of relevant drug allergy to local anesthetics
* Local infection at the site of the block
* Patients with coagulopathies and impaired platelet functions
* Patients with hemodynamic instability
* Previous neurological deficit in lower limb and previous femoral artery grafts or injuries.

Primary outcomes:
measure: mean blood pressure
timeFrame: 20 minutes after anesthesia
Secondary outcomes:
measure: adequate sensory block
timeFrame: 20 minutes after the block
measure: adequate motor block
timeFrame: 15 minutes after the block
measure: time of first analgesic request
timeFrame: within 24 hours after the block
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT06347601: Survey on Sexual and Gender in the Healthcare in Taiwan
Official title: Survey on Sexual Harassment and Gender Discrimination in the Healthcare Sector in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Harassment
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-04-04
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes Taiwanese medical students and physicians who meet the following criteria:

Inclusion Criteria:

Aged 18 years or older. Have received education or practiced in Taiwan's medical colleges or hospitals. Voluntarily agree to participate in the research through questionnaire surveys or interviews.

Exclusion Criteria:

Individuals under 18 years old. Those who have not received education or practiced in Taiwanese medical colleges or hospitals.

Those unable to understand or complete Chinese-language questionnaires. Those unable to participate in interviews.

Brief summary: This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators.


Eligibility criteria: Inclusion Criteria:

Taiwanese medical students or physicians Aged 18 or older Have received education or practiced in Taiwan's medical colleges or hospitals

Exclusion Criteria:

Individuals under 18 years old Have not received education or practiced in Taiwanese medical colleges or hospitals Unable to understand or complete Chinese-language questionnaires

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: