louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01259362: Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients
Official title: Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cocaine Addiction
Treatment
Transcranial Magnetic Stimilation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment.

The aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a treatment with transcranial magnetic stimulation.

Detailed description: Patients are going to submitted do a course of rTMS of one month, each session up to 15 minutes.

After the rTMS they are going to be offered cognitive therapy to prevent relapse.

The area stimulated is the dorso-lateral prefrontal cortex. This technique was employed in previous studies and the risks are insignificant.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18
* Maximum age of 40
* Diagnostic of Cocaine addiction
* Willingly participate the study

Exclusion Criteria:

* Metallic Cerebral Implant
* History of Severe Brain trauma or injury
* Organic Brain Disease
* Severe Somatic Disease
* History of other actual or past psychiatric diagnostics

Primary outcomes:
measure: Minnesota Cocaine Craving Scale(MCCS)
timeFrame: 2 months
Secondary outcomes:
measure: Barrat Impulsiveness Scale vers 11 ( BIS 11)
timeFrame: 2 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
state: SP
Study officials:
affiliation: Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP
name: Philip L Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03713762: Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
Official title: Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, Local
Keywords: Peribulbar block
Lead sponsor: Centro Medico Docente la Trinidad
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.

Detailed description: Article Type. Clinical trial study

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for cataract surgery (Cataract Extracapsular Extraction)
* With indication of regional anesthesia with peribulbar block
* Physical status ASA I or II
* Patients between 45 and 90 years of age

Exclusion Criteria:

* Allergic to amide-type anesthetics and fentanyl citrate
* Patients with a history of woody thorax
* Patients with uncompensated systemic diseases
* Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.

Primary outcomes:
measure: Latency period (lost of corneal reflex)
timeFrame: 10 minutes until the start of surgery
Secondary outcomes:
measure: Ocular akinesia: movements of extraocular muscles
timeFrame: 10 minutes until the start of surgery
measure: Incidence of postoperative pain
timeFrame: 2 Hours
measure: postoperative complications
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01410162: Advagraf/Prograf Conversion Trial
Official title: A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant
Kidney Pancreas Transplant
Keywords: Renal
Kidney/Pancreas
Transplant
conversion
bioequivalence
Mycophenolate Acid
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2011-08-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.


Eligibility criteria: Inclusion Criteria:

* Renal transplant or Renal Pancreas patients who are \> 12 months post transplant
* Stable allograft function defined as eGFR \> 30-60ml/min
* Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months
* Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent

Exclusion Criteria:

* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Treated rejection within 3 months of randomization.
* Increased serum creatinine \> 20% within 3 months of randomization.
* Subject is pregnant or breastfeeding
* Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol

Primary outcomes:
measure: renal function
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Bioequivalence of MPA exposure with Advagraf
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Inc
name: Norman Muirhead
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05626062: Toilet Training and Adults With Learning Disabilities
Official title: Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Incontinence
Learning disabilities
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: University of Kent
First posted: 2022-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A feasibility sample of 30 adults with learning disabilities with incontinence
Primary purpose: TREATMENT

Brief summary: Incontinence is common in adults with learning disabilities (LDs). Behavioural toilet training in conjunction with toilet alarms is recommended for people with LDs, but there is a paucity of research, thus evidence-based practise, on behavioural toilet training for adults with LDs. The aim of this study is to assess the toileting needs and issues of 30 adults with LDs with incontinence, and determine whether a 12-week individualised positive behavioural support training intervention, with the use of toilet alarms, promotes continence.

Detailed description: Adults with learning disabilities with incontinence are being invited to participate in a 12-week personalised, positive toilet training plan, following assessment of their toileting needs. Primary outcome measures will be: number of incidences of incontinence, and number of instances of successful voiding in a toilet. Toilet alarms will be used to encourage prompted voiding in a toilet.

Eligibility criteria: Inclusion Criteria:

- Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound)

Exclusion Criteria:

* Cannot sit on a toilet for up to 3 minutes

Primary outcomes:
measure: Number of instances of incontinence
timeFrame: 12 weeks
measure: Number of instances of successful voiding in a toilet
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Scotland
Study officials:
References:
Clinical trial NCT04677062: Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Official title: Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphthous Stomatitis
Keywords: aphthous lesion
hyaluronic acid
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328 for the treatment of childhood oral aphthous lesion.

Detailed description: Prospective study carried out in the Pediatric Dentistry Department of the International University of Catalonia. The sample was made up of children between 3 and 13 years old. Baseline pain status, functional limitation, edema and lesion diameter were evaluated. The treatment lasted 4 days. The parents recorded the intensity of the pain and the number of pills provided daily. Statistical significance was accepted with p≤0.05 and a 95% confidence interval.

A total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. The average age of the children was 7.8 years (SD: 1.41). Numerical variables referring to pain, inflammation and edema presented statistically significant improvements (p-value \<0.05). Healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor taste acceptability.

Eligibility criteria: Inclusion Criteria:

* Patients aged 3-13 years.
* Children who presented canker sores.

Exclusion Criteria:

* Patients who presented canker sores with 48 h of evolution.
* Patients with diabetic disorders.

Primary outcomes:
measure: The level of pain was measured on the Wong-Baker Faces Scale (WBFS)
timeFrame: 4 DAYS
Secondary outcomes:
measure: The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
timeFrame: 4 DAYS
Other outcomes:
measure: The baseline size of the main lesion was also classified according to its diameter
timeFrame: 4 DAYS
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
Clinical trial NCT00250562: A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.
Official title: A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group Trial Comparing the Combinations of Valsartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Valsartan 80 mg in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Angiotensin II receptor blocker
fixed combination
diuretics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 1171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide.

The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.

This study is not recruiting in the US.


Eligibility criteria: Inclusion Criteria:

* - Male or female Outpatients 18 years and older.
* Patients with hypertension defined as the following:
* Newly diagnosed hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg.at Visit 1 and 2, Pre-treated hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg at Visit 2
* For entrance into the double-blind treatment period (Visit 3), all patients should have a MSDBP of \> 90 mmHg and \< 110 mmHg
* Patients must have given written informed consent to participate and be willing to participate in the entire study

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References:
citation: Sun NL, Zhu JR, Zhao Y, Tu YM; Co-Diovan Trial Investigators. Combination antihypertensive therapy with valsartan and hydrochlorothiazide in Chinese patients with mild-to-moderate hypertension. Curr Med Res Opin. 2008 Oct;24(10):2863-71. doi: 10.1185/03007990802390647. Epub 2008 Aug 29.
Clinical trial NCT02357862: Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty
Official title: Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tricuspid (Valve); Deformity
Keywords: Cardiovascular Diseases
Heart Valve Diseases
Mitral Valve Annuloplasty
Tricuspid Valve Insufficiency
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing minimally invasive, isolated mitral valve annuloplasty in the University Hospitals Leuven

Brief summary: The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

Detailed description: The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

Eligibility criteria: Inclusion Criteria:

* all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty

Exclusion Criteria:

* concomitant tricuspid valve surgery
* atrial fibrillation at the moment of surgery
* poor echocardiographic windows

Primary outcomes:
measure: Postoperative geometric changes in tricuspid valve annulus (TA)
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology
name: Werner Budts, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376462: Quantra® System With the QStat® Cartridge in Trauma
Official title: An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Trauma
Coagulation Defect; Bleeding
Keywords: Quantra
QStat
Viscoelastic testing
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Lille
First posted: 2022-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients requiring a full trauma team response.

Brief summary: This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.

Detailed description: This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.

Eligibility criteria: Inclusion Criteria:

* Subject is \> 18 years; Children under the age of 18 are protected by adults under guardianship or by court order.
* Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria.
* Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria

* Subject is pregnant.
* Subject is currently enrolled in a distinct study that might confound the result of the proposed study.
* Subject is not covered by social security.

Primary outcomes:
measure: Total units of red blood cells (RBC) transfused
timeFrame: 24 hours post-presentation for trauma subjects
Secondary outcomes:
measure: Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused
timeFrame: 48 hours after admission to the hospital
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Universitaire de Lille
state: Nord Pas De Calais
Study officials:
References:
Clinical trial NCT00775762: Anti-Inflammatory and Anti-Platelet Effect of Clopidogrel and Aspirin vs Aspirin Alone in Symptomatic Polyvascular Disease and in Patients With Multiple Recurrent Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Polyvascular Disease
Cardiovascular Disease
Keywords: Symptomatic Polyvascular disease
Multiple recurrent cardiovascular events
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 213
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic polyvascular disease or recurrent cardiovascular events. In particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events.

Exclusion Criteria:

* chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy;
* intolerance/allergy to Aspirin or to Clopidogrel
* platelet counts outside the range of 125-450 10\^9/l
* inflammatory or infectious disease
* malignancies or immunologic or hematological disorders.

Primary outcomes:
measure: The aim of the present study is to demonstrate the superior antinflammatory effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of levels of selected circulating inflammatory markers
timeFrame: three months
Secondary outcomes:
measure: The aim of the present study is to demonstrate the superior antiplatelet effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of TXA2 serum levels
timeFrame: three months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart, Department of Cardiovascular Medicine
Study officials:
References: