louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01403012: BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis
Official title: Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psoriasis
Keywords: To identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis
To identify metabolomic signatures associated with psoriasis
To identify possible treatment-specific metabolomic signatures
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psoriasis patients

Brief summary: Metabolomics of systemic psoriasis treatment


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 - 80 years, body weight ≤ 180 kg
* Dermatological diagnosis of psoriasis
* Initiated therapy with TNFα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (FAE) within the scope of routine patient care by treating physician
* Signed informed consent from patient

Exclusion Criteria:

* Patients with evidence of any skin condition that would interfere with the evaluation of psoriasis
* Use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of Visit 1 or used FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to Visit 1
* Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
* Patients who are unable to complete a patient diary or complete questionnaires on paper
* Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
* Pregnancy or breast feeding women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study. Effective contraception is defined as either: use of established oral, injected or implanted hormonal

Primary outcomes:
measure: Analysis of metabolic profiles associated with treatment response
timeFrame: week 0 and week 12
Secondary outcomes:
measure: Identification of metabolomic signatures associated with psoriasis
timeFrame: week 0 and week 12
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Dermatology and Allergy, Uniklinik Kiel
state: Schleswig-holstein
Study officials:
affiliation: Dermatology, University Kiel
name: Stephan Weidinger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04082312: Acute Kidney Injury in Adult Patients Supported by VA-ECMO
Official title: Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Cardiogenic Shock
Keywords: Acute Kidney Injury
ECMO
Post Cardiogenic Shock Syndrome
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in the Surgical Intensive Care Unit of the Cardiology Institute of La Pitié Salpêtrière University Hospital (Paris, France) between January 2013 and December 2016.

Brief summary: Post-cardiotomy cardiogenic shock (PCCS) occurs in 2-6% of patients undergoing cardiac surgery, and 1% of cardiac surgery patients will require mechanical circulatory support using Veno-Arterial ExtraCorporeal Membrane Oxygenation (VA-ECMO). Acute Kidney Injury is a frequent complication in this population and negatively impacts the survival. We aimed to determine whether the timing of ECMO implantation influence the renal prognosis of these patients.


Eligibility criteria: Inclusion Criteria:

* All patients admitted in post-operative of cardiac surgery
* Assisted by VA-ECMO

Exclusion Criteria:

* Chronic hemodialysis
* Death occurring within the first 48 hours of VA-ECMO implantation
* Multiple VA-ECMO during the same hospitalization.

Primary outcomes:
measure: Occurrence of a stage 3 AKI
timeFrame: Day 10 after ECMO implantation
Secondary outcomes:
measure: Mortality at Day 30
timeFrame: Day 30 after ECMO implantation
measure: Mortality at 6 months
timeFrame: 6 months after ECMO implantation
Other outcomes:
Locations:
city: Paris
country: France
facility: Dr Adrien Bouglé
Study officials:
References:
citation: Lepere V, Duceau B, Lebreton G, Bombled C, Dujardin O, Boccara L, Charfeddine A, Amour J, Hajage D, Bougle A. Risk Factors for Developing Severe Acute Kidney Injury in Adult Patients With Refractory Postcardiotomy Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Crit Care Med. 2020 Aug;48(8):e715-e721. doi: 10.1097/CCM.0000000000004433.
Clinical trial NCT00511212: Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
Official title: Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peritonitis
Postoperative Complications
Keywords: severe peritonitis
SSI
lower digestive tract surgery
Severe peritonitis after lower digestive tract surgery
Lead sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
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 assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.


Eligibility criteria: Inclusion Criteria:

Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.

1. Patients with \>=38 degrees C, \>=15,000/mm3 or \<=3,000/mm3 of WBC and \>=10mg/dL of CRP
2. Patients who have no abscess on the abdominal image
3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
4. Patients who are 20 years old or older
5. Patients who have signed the agreement for participation in this study

Exclusion Criteria:

1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
3. Patients who were administered immunoglobulin within 1 month before entry
4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
5. Patients with IgA deficiency
6. Patients with hereditary fructose intolerance
7. Patients with history of allergy or adverse effect for antibacterial agents
8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
9. Patients who are or could be pregnant
10. Patients who have noninfectious fever, fungal infection or viral illness
11. Other patients who are judged to be inadequate to participate in this study by their physician

Primary outcomes:
measure: clinical efficacy
timeFrame: at day 7
Secondary outcomes:
measure: clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms
timeFrame: at day 3 and at the end of test drug administration,
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Multicenter Clinical Study Group of Osaka
name: Morito Monden, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01694212: Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Official title: Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Cataract
Diabetic Retinopathy
Keywords: Macular edema
Cataract
Diabetic retinopathy
Anti-inflammatory agents,Non-steroidal
Lead sponsor: Eye Clinic Medic Zuljan Jukic
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Center, Split
name: University of Zagreb
First posted: 2012-09-27
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.


Eligibility criteria: Inclusion Criteria:

* presence of nonproliferative diabetic retinopathy
* presence of the cataract (LOCS 2-3)

Exclusion Criteria:

* other chronic or acute eye diseases
* hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
* allergy to salycilates

Primary outcomes:
measure: Change of Central Macular Thickness
timeFrame: -7, 0, 1, 7, 30, 90 days after the cataract surger
Secondary outcomes:
measure: progression of diabetic retinopathy
timeFrame: -7 and 90 days after cataract surgery
measure: IL-12 concentration
timeFrame: immediately before cataract surgery
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Poliklinika Medic Zuljan Jukić
Study officials:
affiliation: Clinical Hospital Center, Split
name: Ljubo Znaor, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001612: Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Official title: Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Long-Term Visual Outcome
Photocoagulation
J. H. Wilmer Eye Institute
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. The progression of retinopathy will be evaluated by ocular exam and fundus photography. A brief medical history will be obtained. The goal of this study is to evaluate the long-term results of patients whose diabetic retinopathy was treated with different strategies of scatter and/or focal laser photocoagulation.

Detailed description: To evaluate the long-term clinical course and prognosis of diabetic retinopathy treated with different strategies of scatter and/or focal laser photocoagulation in patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).

Eligibility criteria: Patient was originally enrolled in the Early Treatment Diabetic Retinopathy Study at the Johns Hopkins Wilmer Eye Institute.

Patient not previously enrolled are not eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Eye Institute (NEI)
state: Maryland
Study officials:
References:
citation: Ferris FL 3rd. How effective are treatments for diabetic retinopathy? JAMA. 1993 Mar 10;269(10):1290-1. No abstract available.
Clinical trial NCT05721612: Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach
Official title: Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Elevation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla.

Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).


Eligibility criteria: Inclusion Criteria:

* Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
* Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
* Good oral hygiene

Exclusion Criteria:

* Uncontrolled Diabetes.
* Coagulation disorders.
* Immunological disorders.
* Previous radiation of the head and neck region.
* Abnormal bone physiology.
* Therapy with Bisphosphonates.

Primary outcomes:
measure: Change in bone density
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in implant stability
timeFrame: Baseline and 6 months
measure: change in pain scores
timeFrame: 1st day, 3rd day and 1 week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04838912: Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
Official title: Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Autism
Keywords: CBT
Anxiety
Autism
Feasibility
Teenagers
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fifteen teenagers aged 13-17 years with an active ASD diagnosis and experiencing life interference anxiety symptoms will be divided into 3 groups and treated with the Cool Kids AST anxiety program
Primary purpose: TREATMENT

Brief summary: The objective is to investigate the feasibility of a newly developed manualised group Cognitive Behavioural Therapy (CBT) programme for anxiety in 15 teenagers (aged 13-17 years) with Autism Spectrum Disorder (ASD). Our aim is to focus primarily on acceptability and compliance with the program with some investigation of treatment effects on anxiety diagnosis and anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

* Fulfil the diagnostic criteria for one or more anxiety diagnoses on the Anxiety Disorders Interview Schedule for DSM-IV: Parent \& Child interview schedule (ADIS C/P)
* Obtained a diagnosis of ASD according to the International Classification of Diseases, 10th edition (ICD 10)

Exclusion Criteria:

* low intellectual functioning (\<70)
* active psychosis
* untreated hyperkinetic disorder
* inability to speak Danish
* inability to leave the home
* inability to attend a group setting
* inability to meet for treatment caused by other psychiatric disorders.

Primary outcomes:
measure: The Experience of Service Questionnaire
timeFrame: Interview at 14 weeks after start of treatment
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
timeFrame: Change from baseline interview results at 14 weeks
measure: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
timeFrame: Change from baseline interview results at 3 months
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: Change from baseline results at 14 weeks
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: Change from baseline results at 3 months
measure: Children's Anxiety Life Inference Scale (CALIS)
timeFrame: Change from baseline results at 14 weeks
measure: Children's Anxiety Life Inference Scale (CALIS)
timeFrame: Change from baseline results at 3 months
measure: Children's Automatic Thoughts Scale (CATS)
timeFrame: Change from baseline results at 14 weeks]
measure: Children's Automatic Thoughts Scale (CATS)
timeFrame: Change from baseline results at 3 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Auhus University Hospital, Psychiatry
Study officials:
References:
Clinical trial NCT00188812: Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease
Official title: Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia Associated With Cerebrovascular Disease
Keywords: dementia
stroke
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2005-09-16
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: one year extension study following a previous double-blind study to evaluate safety of the drug

Detailed description: A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd.

Eligibility criteria: Inclusion Criteria:

* must have completed previous study E2020-A001-319

Exclusion Criteria:

* absence of a reliable caregiver
* clinically significant medical condition
* recent TIA

Primary outcomes:
measure: safety assessments
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hopital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Karl Farcnik, MD FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695612: EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS
Official title: EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inclined Implants
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 22
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 aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.


Eligibility criteria: Inclusion Criteria:

* Patients should be completely edentulous.
* Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
* Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
* The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Exclusion Criteria:

* Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
* Patients with active oral infections.
* Patients with history of radiotherapy in head and neck region.
* Patients with poor oral hygiene.
* Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
* Heavy smokers (more than 10 cigarette / day).

Primary outcomes:
measure: Peri-implant Probing Depth (PD)
timeFrame: up to 12 months
measure: Modified Sulcus Bleeding Index (BI)
timeFrame: up to 12 months
measure: Modified gingival index
timeFrame: up to 12 months
measure: Alveolar bone level
timeFrame: up to 12 months
measure: Implant stability
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Haitham Ismail, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Ahmed Al-Shimy, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Tarek S Abdelazim, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Kenda IH Hanno, PhD
role: STUDY_CHAIR
References: