louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00650650: Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures
Official title: Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Fracture
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 80
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: Patients with suspected nasal fracture.

Brief summary: The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. It has been shown that the bony structures of the nose can be well examined by ultrasound in the last few years. The hypothesis: "Is ultrasound of equal diagnostic accuracy in diagnosing nasal fractures as radiography" is being tested in the investigators' study. Patients with suspected nasal fracture undergo ultrasound examination in addition to the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.


Eligibility criteria: Inclusion Criteria:

* suspected nasal fracture

Exclusion Criteria:

* further fractures
* pregnancy
* unstable condition
* refusal to undergo ultrasound examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik für Hals-Nasen-Ohrenheilkunde, LMU München
state: Bayern
Study officials:
References:
Clinical trial NCT03218150: Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
Official title: Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Decompression Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 1
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient's that need cranioplasty surgery admitted in assiut university hospital

Brief summary: Prospective, comparative, observational study.

The project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety among the 3 types of treatment.

Eligibility to each treatment will respect the standard clinical practice.

Primary outcome: minimize post operative infection

Secondary outcomes: decrease operation time , clinical and psychological improvement of the patient, decrease the cost on the patient

Detailed description: Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, ongoing researches on both biologic and non biologic substitutions continue aiming to develop the ideal reconstruction material.

Autologous bone grafts remain the best option for adult and pediatric patients with viable donor sites and small-to-medium defects. Large defects in the adult population can be reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use of computer-assisted design and manufacturing customization. Advances in alloplastic materials and custom manufacturing of implants will have an important influence on cranioplasty techniques in the years to come.

Eligibility criteria: Inclusion Criteria:

1. All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .
2. Age older than 10 and less than 60 years
3. Provided written informed consent

Exclusion Criteria:

1. Cases of cranial defects due to congenital anomalies or growing skull fractures .
2. Severe disease with limited life expectancy of less than one year

Primary outcomes:
measure: safety : minimize incidence of infection
timeFrame: 360 days after surgery
Secondary outcomes:
measure: efficacy
timeFrame: 60 , 120 , 360 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00386750: Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
Official title: An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Malaria
Falciparum
Keywords: Malaria
hearing
co-artemether
auditory
Plasmodium falciparum
marsh fever
Plasmodium infections
remittent fever
paludism
artemether
artemisinins
benflumetol
lumefantrine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 265
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.


Eligibility criteria: Inclusion Criteria

* 12 years of age or older
* P. falciparum parasitemia between 50 and 100,000 parasites/μl
* History of fever or presence of fever (temperature ≥ 37.5°C)

Exclusion Criteria

* Signs/symptoms of severe/complicated malaria
* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
* History of any drug-related hearing impairment.
* Abnormal hearing function at study entry
* Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems

(Other protocol-defined inclusion/exclusion criteria may apply.)

Primary outcomes:
measure: Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
Secondary outcomes:
measure: Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
measure: Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)
measure: Relationship between changes in auditory function and drug exposure.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT06348550: Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.
Official title: Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. Single-center, Randomized, Double-blind Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslipidemias
Dysglycemia
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2024-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

Detailed description: The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese subjects \[according to body mass index (BMI)\]
* Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
* Total cholesterol values ≥ 200 mg/dl

Exclusion Criteria:

* Patients with neoplastic and liver diseases, renal failure
* Patients with type 1 or 2 diabetes mellitus
* Pregnant or breastfeeding women
* Hypersensitivity to any of the ingredients
* Therapy with lipid-lowering drugs
* Use of products containing red yeast rice

Primary outcomes:
measure: Variation of LDL cholesterol
timeFrame: 12 months
Secondary outcomes:
measure: Variation of lipid profile
timeFrame: 12 months
measure: Change in glycemic status
timeFrame: 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo Foundation
Study officials:
References:
Clinical trial NCT00469950: The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
Official title: Effect of Exercise Training After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: PCI
stent
training
endothelial function
restenosis
late luminal loss
heart rate variability
oxygen uptake capacity
inflammatory markers
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2007-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.

Detailed description: Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).

Eligibility criteria: Inclusion Criteria:

* Successful PCI with stent implantation,
* Able to participate in the training program,
* No planned further revascularisation

Exclusion Criteria:

* CAGB,
* Inflammatory diseases other than CAD,
* Heart failure,
* Severe kidney failure,
* Inability to participate in the training program

Primary outcomes:
measure: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN
timeFrame: 6 months
Secondary outcomes:
measure: Oxygen uptake capacity (mg/kg/min), Sf36 scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Peter S Munk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munk PS, Breland UM, Aukrust P, Ueland T, Kvaloy JT, Larsen AI. High intensity interval training reduces systemic inflammation in post-PCI patients. Eur J Cardiovasc Prev Rehabil. 2011 Dec;18(6):850-7. doi: 10.1177/1741826710397600. Epub 2011 Feb 18.
citation: Munk PS, Staal EM, Butt N, Isaksen K, Larsen AI. High-intensity interval training may reduce in-stent restenosis following percutaneous coronary intervention with stent implantation A randomized controlled trial evaluating the relationship to endothelial function and inflammation. Am Heart J. 2009 Nov;158(5):734-41. doi: 10.1016/j.ahj.2009.08.021.
Clinical trial NCT03080350: Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope
Official title: Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain Due to Trauma
Keywords: Fentanyl
Transmucosal administration
Endovenous administration
Pain therapy
Mountain emergency medicine
Lead sponsor: Azienda Sanitaria dell'Alto Adige
Sponsor class: OTHER
Collaborators: name: Institute of Mountain Emergency Medicine
First posted: 2017-03-15
Enrollment: 108
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 determine the non-inferiority of the efficacy for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope

Detailed description: Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough cancer pain relief in oncologic patients.

The immediate (less than 10 minutes) effect and the ease of administration of sublingual fentanyl is a feasible drug administration for immediate analgesia in remote areas such as mountain rescue missions eg. the slope.

Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.

Safety issues like control of vital signs will be warranted.

Eligibility criteria: Inclusion Criteria:

* Trauma on the limbs with a pain score of 4 or more on the slope
* ASA I - II

Exclusion Criteria:

* children (\< 18 years)
* cognitive impairment: brain injury, intoxication, analgesia
* weight under 50 kg and more than 100 kg
* other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
* chronic analgesic use or misuse
* allergy
* fear of needles
* pregnancy
* speech difficulties

Primary outcomes:
measure: Pain - Relief
timeFrame: 1 hour
Secondary outcomes:
measure: Practicability / handling of the two dosage forms of fentanyl in emergencies
timeFrame: 1 hour
measure: Patient comfort
timeFrame: 1 hour
measure: Adverse drug effects
timeFrame: 1 hour
measure: SpO2 (%)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bruneck
country: Italy
facility: Skiresort - Kronplatz
Study officials:
affiliation: Südtiroler Sanitätsbetrieb - Bruneck Hospital
name: Rosmarie Oberhammer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742950: Refractive Change Induced by 2.8-mm Corneal Incision
Official title: Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Refractive Surgery
Astigmatism
Keywords: Corneal incision
Cataract surgery
Phacoemulsification
Surgically induced astigmatism
Corneal Topography
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.

Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.

Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.


Eligibility criteria: Inclusion Criteria:

* Visual impairment for daily tasks caused by cataract
* Age older than 50 years
* Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
* Ability to cooperate in the protocol procedures

Exclusion Criteria:

* Age below 50
* Inability to cooperate with measurements

Primary outcomes:
measure: Induced corneal refractive change
timeFrame: 6 months
Secondary outcomes:
measure: ISV change
timeFrame: 6 months
measure: Visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Dept Ophthalmology, Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Dept Ophthalmology
name: Jaime Tejedor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept Ophthalmology
name: José A Pérez-Rodríguez, MD
role: STUDY_CHAIR
References:
citation: Tejedor J, Murube J. Choosing the location of corneal incision based on preexisting astigmatism in phacoemulsification. Am J Ophthalmol. 2005 May;139(5):767-76. doi: 10.1016/j.ajo.2004.12.057.
citation: Tejedor J, Perez-Rodriguez JA. Astigmatic change induced by 2.8-mm corneal incisions for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):989-94. doi: 10.1167/iovs.08-2778. Epub 2008 Nov 14.
Clinical trial NCT01753050: HIP Surgery - Hemodynamic Optimization Project
Official title: A Quality Improvement Project for Goal-directed Intraoperative Hemodynamic Optimization in Patients Redo Hip Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Redo Hip Surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2012-12-20
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery reduces morbidity and length of hospital stay. This quality improvement is design to evaluate the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary combined endpoints will be the incidence of postoperative complications and the secondary endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital postoperative mortality. We amended another 130 patients getting crystalloid fluids in the hemodynamic optimization protocol.


Eligibility criteria: Inclusion Criteria:

* patients undergoing redo hip surgery
* age above 18 years
* signed informed consent

Exclusion Criteria:

* urgent or emergency surgery

Primary outcomes:
measure: postoperative complications
timeFrame: 30days
Secondary outcomes:
measure: length of hospital and ICU stay
timeFrame: 30days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Study officials:
affiliation: Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
name: Sascha Treskatsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habicher M, Balzer F, Mezger V, Niclas J, Muller M, Perka C, Kramer M, Sander M. Implementation of goal-directed fluid therapy during hip revision arthroplasty: a matched cohort study. Perioper Med (Lond). 2016 Dec 13;5:31. doi: 10.1186/s13741-016-0056-x. eCollection 2016.
Clinical trial NCT05848050: Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
Official title: Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: monocentric, prospective, interventional, exploratory study
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine in brain metastases and according to feasibility in liquid biopsies:

* Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing;
* The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome;
* Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.

Detailed description: This is a single-center, prospective, interventional, exploratory study aimed at comparing the molecular alteration profile of liquid biopsies (blood and lumbar puncture) to that of brain metastases.

The population eligible for the study will consist of any patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision.

The study consists of comparing, between brain metastases and liquid biopsies (blood and lumbar puncture), the profiles of genomic, post-genomic and epigenetic alterations as well as the mutational load. To do this, the study only requires a lumbar puncture and a blood test.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over;
* Patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision (contrast enhancement of at least 1 cm);
* Patient able to understand the information related to the study and to read the information leaflet;
* Patient having signed a written informed consent to participate in the study.

Exclusion Criteria:

* Patient with a medical contraindication to surgery and anesthesia;
* Patient whose anatomical location of the cerebral metastasis contraindicates wide resection;
* Patient with a contraindication to performing a lumbar puncture;
* Pregnant, parturient or breastfeeding women;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: molecular alteration profile of liquid biopsies
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Privé Clairval
Study officials:
References: