louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05660694: Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis
Official title: Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Triamcinolone
Pentoxifylline
Vitamin E
Oral Submucosa Fibrosis
Tumor
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Triamcinolone Group 2: Pentoxifylline
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

Detailed description: To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past
* Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking
* Patients who are ready to attend regular follow-ups

Exclusion Criteria:

* Patients who have undergone any treatment for OSF in past
* Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's
* Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol

Primary outcomes:
measure: Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
timeFrame: 21 months
measure: Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Altamash Institute of Dental Medicine
state: Sindh
Study officials:
References:
Clinical trial NCT02941094: Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Internal Jugular Vein Cannulation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam


Eligibility criteria: Inclusion Criteria:

* all patients requiring central line insertion

Exclusion Criteria:

* refusal
* coagulopathy
* neck surgeries

Primary outcomes:
measure: success rate
timeFrame: 24 hours starting from central line insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT02985294: Peripheral Physiological Measures as Determinants of Pain Risk
Official title: DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polyneuropathies
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Chemotherapy Effects
Neuralgia
Keywords: Neuropathic pain
Quantitative Sensory Testing
Multiple Excitability Measures
Threshold Tracking
Lead sponsor: Neuroscience Technologies SLP, Barcelona
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Aarhus
name: University of Dundee
First posted: 2016-12-07
Enrollment: 200
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: 1. Painless patients and patients with chronic peripheral neuropathic pain
2. Susceptible patients for developing pain i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as taxol, vincristine, etc.

Brief summary: This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"

Detailed description: Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:

1. Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.
2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:

i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine

Eligibility criteria: Inclusion Criteria:

* Chronic peripheral neuropathic pain
* Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Electrophysiological pain phenotypes using MEM. Pain biomarker
timeFrame: Single assessment (cross sectional study) at the first and only visit
measure: Electrophysiological pain phenotypes using MEM. Pain predictor
timeFrame: Single assessment at baseline, before any procedure (surgery/chemotherapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Neuroscience technologies
Study officials:
References:
Clinical trial NCT04798794: PCO2 ELSO (Extracorporeal Life Support Organization)
Official title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: Ecmo
Neonates
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 4072
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (\<28 j) supported by ECMO for severe respiratory failure

Brief summary: Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

Detailed description: Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.

Eligibility criteria: Inclusion Criteria :

* Support by ECMO for respiratory indication

Exclusion Criteria :

* None

Primary outcomes:
measure: Acute Neurological Event
timeFrame: Up to 90 days after ECMO initiation
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days after ECMO start
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT03601494: Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain
Official title: Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Chronic Pain
Keywords: Diabetic Neuropathies
Chronic pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).

Detailed description: Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.

The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.

Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.

Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.

Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.

Autologous platelet-rich plasma found to promote axon regeneration in studies involving animal models. Platelet derived angiogenesis factors are capable of stimulating new capillary growth by inducing migration of endothelial cells. It was suggested that this was the mechanism by which platelet factors influence the process of angiogenesis and revascularization.

Eligibility criteria: Inclusion Criteria:

* type II diabetes mellitus
* diabetic peripheral neuropathy
* six months duration of symptoms,

Exclusion Criteria:

* other causes of neuropathy
* patient refusal
* ulcers or amputations
* peripheral vascular diseases
* vertebral spine disease
* connective tissue disease
* platelet dysfunction syndrome
* critical thrombocytopenia
* local infection
* coagulopathy

Primary outcomes:
measure: visual analog scale of pain
timeFrame: 6 months
Secondary outcomes:
measure: Nerve conduction velocity
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT00151294: The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis
Official title: A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Multiple Sclerosis
Keywords: Depression (mild to moderate)
Affective symptoms
Emotional lability
Multiple Sclerosis
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2005-09-08
Enrollment: 20
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: Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.

Detailed description: Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* Having mild to moderate depressive symptoms, with or without emotional lability
* Experiencing psychological distress

Exclusion Criteria:

* Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis
* Cognitive impairment
* The presence of an unstable medical illness that might preclude completion of the study -

Primary outcomes:
measure: Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
measure: Adverse events for both groups will be similar
Secondary outcomes:
measure: Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.
Other outcomes:
Locations:
city: White Plains
country: United States
facility: NewYork Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Barnett S Meyers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01396694: An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery
Official title: Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Predictors
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 yrs

Brief summary: All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.


Eligibility criteria: Inclusion Criteria:

* require arthroscopy or arthroplasty

Exclusion Criteria:

* age less than 18 yrs
* prior surgery
* unable to give informed consent

Primary outcomes:
measure: Pain
timeFrame: 3 months
Secondary outcomes:
measure: Function
timeFrame: 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT00963794: Diagnosis of Rectal Cancer by Electromagnetic Device
Official title: Clinical Investigation on a Device for the Diagnosis of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Population screening
Early detection
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal \< 50 units (U).

Detailed description: Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.

Eligibility criteria: Inclusion Criteria:

* Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.

Exclusion Criteria:

* Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Primary outcomes:
measure: Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
state: MI
Study officials:
References:
Clinical trial NCT01297894: Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
Official title: Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Drug Safety
Keywords: A. baumannii
colistin
fosfomycin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 92
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: In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Detailed description: Inclusion criteria

* Age\> 18 years
* Hospitalized to Siriraj Hospital
* Infected caused by A. baumannii
* Need Colistin treatment

Exclusion criteria

* Pregnancy or Lactating mother
* Colistin or Fosfomycin Allergy
* Patients who have severe abnormal renal or liver function

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Hospitalized to Siriraj Hospital
* Infected caused by A. baumannii
* Need Colistin treatment

Exclusion criteria:

* Pregnancy or Lactating mother
* Colistin or Fosfomycin Allergy
* Patients who have severe abnormal renal or liver function

Primary outcomes:
measure: number of subjects with cure or improvement
timeFrame: up to 28days
Secondary outcomes:
measure: number of subjects with eradication of causative bacteria
timeFrame: up to 28days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5598-601. doi: 10.1128/AAC.02435-13. Epub 2014 Jun 30.
Clinical trial NCT00268294: Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)
Official title: Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Atrial Arrhythmia
Keywords: cardiac resynchronization therapy, atrial arrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).

Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.

The purpose of this study is to characterize the impact of cardiac resynchronization therapy versus cardiac resynchronization therapy with atrial therapies on the incidence, duration and termination of atrial tachyarrhythmias.


Eligibility criteria: Inclusion Criteria:

* Subjects with atrial fibrillation
* Subjects with a heart beat that is too fast and who have been determined by a doctor to require an implantable cardioverter defibrillator (ICD) i.

Exclusion Criteria:

* Subjects with a natural heart rate less than 30bpm

Primary outcomes:
measure: To compare the AF burden, frequency and duration of episodes when atrial therapies are ON vs. OFF.
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
Study officials:
affiliation: Zentralklinik Bad Berka GmbH
name: Burkhard Huegl, MD
role: PRINCIPAL_INVESTIGATOR
References: