louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00837356: Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Official title: A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 23
Sex: MALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.


Eligibility criteria: Inclusion Criteria:

* Severe haemophilia A (FVIII level less than or equal to 1%)
* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial

Exclusion Criteria:

* Presence of any bleeding disorder in addition to haemophilia A
* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
* Abnormal renal function tests
* Known hypersensitivity to Advate®

Primary outcomes:
measure: Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
timeFrame: at 30 days
Secondary outcomes:
measure: Inhibitor development
timeFrame: at 30 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Tel-Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.
Clinical trial NCT03415256: The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Official title: The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Neuropathies
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * After completing the tests, you will be randomly assigned by the computer to either the treatment group or control group.
* The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
* The control group will not receive any treatment and they will continue their usual lifestyle.
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).

Detailed description: The study involves the following:

* Visit 1:
* Particpant's age, height, gender, and weight will be collected.
* Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
* Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
* After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
* The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
* The control group will not receive any treatment and they will continue their usual lifestyle.
* Visit 2 through 8:
* The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
* The control group will continue their usual lifestyle.
* In the fifth session, the treatment and control groups will come back for tests.
* Visit 9 (follow-up):

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Diabetic Peripheral Neuropathy
* Minimum age 40 years
* Maximum Age 75 years
* Ability to stand for a minimum of five minutes

Exclusion Criteria:

* Neurological Disorders
* Bleeding Disorders
* Leg Ulcers
* Cardiovascular Diseases
* Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
* Self-reported pregnancy

Primary outcomes:
measure: Skin blood flow
timeFrame: Change between Baseline and Week Nine Visit
Secondary outcomes:
measure: balance
timeFrame: at each of the nine visits( 90 minutes each visit: twice per week)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Everett Lohman, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449056: High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
High-flow Nasal Cannula
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.


Eligibility criteria: Inclusion Criteria:

* Arterial pH over 7.25,
* Respiratory rate under 35 breaths/mn
* Glasgow Coma Scale equal to 15,
* indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
* NIV sessions spaced more than 6 hours.

Exclusion Criteria:

* Urgent endotracheal intubation;
* Contraindication to beta 2 adrenergic agonist;
* Another organ failure (hemodynamic and neurological instability);
* Cardioselective beta-blocker during treatment of copd exacerbation;

Primary outcomes:
measure: compare lung functions
timeFrame: baseline-1h30
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U. de Poitiers
Study officials:
References:
Clinical trial NCT04983056: Management of Fournier Gangrene at Ibn Rochd University Hospital Center
Official title: Fournier's Gangrene: Seven Years of Experience in the Emergencies Service of Visceral Surgery at Ibn Rochd UHC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fournier Gangrene
Keywords: Fournier's Gangrene, stoma, necrosectomy
Lead sponsor: Centre Hospitalier Universitaire Ibn Rochd
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 84
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: . Patients with Fournier Gangrene

Brief summary: Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.

Detailed description: Eight four (84) patients were recruited. The average age of our patients was 49 years (with limits of 20 to 76), the male gender dominates our series (83.33%) with a sex ratio of 5M / 1W, the most frequently found risk factor was diabetes mellitus (37%). The most common etiology was anal abscesses (32%). The average time to consultation was 8 days (limits ranges from 3 to 30 days). All patients were admitted at a necrosis stage (100%). Anemia was identified in 85% of cases. The low platelets were noticed in 44.03% of cases. Hypoalbuminemia was found in 93% of cases. All patients (100%) benefited resuscitation initially and antibiotic therapy on their admission. They received emergency surgical debridement with a cleansing stoma. The average length of hospital stay was 13 days and complications occurred in 33% of cases. The mortality rate was 7.14%. then we conclude that Fournier's gangrene is a medico-surgical emergency with a high morbidity and mortality rate. Early diagnosis as well as antibiotic therapy and the quality of debridement save the patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Fournier Gangrene

Exclusion Criteria:

* Other perineal diseases which are differential diagnosis of Fournier gangrene

Primary outcomes:
measure: Number of patients who died for fournier gangrene
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02429856: Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)
Official title: SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Knee Arthroplasty, Total
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 100
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: This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

Detailed description: RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.

Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.

Eligibility criteria: Inclusion Criteria:

* scheduled for primary TKA
* non-inflammatory arthritis
* intact Posterior Cruciate Ligament at the time of surgery

Exclusion Criteria:

* required bone grafting of either the femur or tibia
* varus or valgus deformity of \> 15 degrees
* previous high tibial osteotomy
* unable to understand or comply with the study requirements
* unable to provide signed informed consent

Primary outcomes:
measure: Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain
timeFrame: 10 years postoperative
measure: WOMAC Osteoarthritis Index Function
timeFrame: 10 years
Secondary outcomes:
measure: RAND -36 Health Survey
timeFrame: 10 years postoperative
measure: Revision Rate
timeFrame: within 10 years of surgery
measure: Number of Complications
timeFrame: within 10 years of surgery
measure: Knee Range of Motion
timeFrame: knee ROM at 2 years postoperative
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services - Edmonton zone
state: Alberta
Study officials:
References:
citation: Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.
Clinical trial NCT03021356: Comparison of TrIfecta and Perimount Magna Ease
Official title: Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Xenograft Hemodynamics
Lead sponsor: Kerckhoff Klinik
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2017-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 75 years
* Elective aortic valve replacement in patients with predominant aortic stenosis

  * including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
* Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
* Native German speakers (quality of life questionnaire in German language)

Exclusion Criteria:

* Isolated aortic regurgitation
* Concomitant aortic regurgitation \> 2°
* Endocarditis
* LVEF \<40%
* Concomitant other valve surgery
* s/p valve surgery
* Contraindication for stress echocardiography

Primary outcomes:
measure: Transprosthetic pressure gradient at stress exercise echocardiography
timeFrame: Echo at follow up stress echo (at 10 months)
Secondary outcomes:
measure: Transprosthetic pressure gradient at discharge echo
timeFrame: Echo at discharge (usually postoperative day 5 to 7)
measure: Left ventricular mass regression calculated by echocardiography (gram)
timeFrame: Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)
measure: Quality of life using the EQ-5D-3L questionnaire
timeFrame: 1 to 5 days before surgery and at follow up (10 months)
measure: BNP plasma level
timeFrame: 1 to 5 days before surgery and at follow up (10 months)
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
Study officials:
References:
Clinical trial NCT03450356: The German Version of the Awareness of Social Inference Test
Official title: The German Version of the Awareness of Social Inference Test: Development of a Short and Sensitive Version for Use in Clinical Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Cognition
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 240
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Goal of the current project is the development of a German-language test battery for a realistic investigation of core areas of social issues Cognition (emotion, perspective taking). This test battery should be used in the investigation of patients with neuropsychological disorders. Investigators plan to establish a German-version of the TASIT that is more sensitive and shorter in administration than the original TASIT.


Eligibility criteria: Inclusion Criteria:

* from the age of 35,
* at least 7 years of education
* understand German or Swiss German
* Subjective statement of good health
* Signed consent

Exclusion Criteria:

* Montreal Cognitive Assessment (MoCA) value below the fifth percentile of subjectively cognitive healthy persons
* signs of depressive mood (Geriatric Depression Scale (GDS) score ≥ 5 points or Beck Depression Inventory (BDI) ≥ 10 points)
* Severe sensory deficits with potentially negative influence test results
* Severe motor deficits with potentially negative influence test results
* Systemic diseases or brain diseases with potentially negative Influence on test results
* St. n. Traumatic brain injury (with unconsciousness of at least 30 minutes)
* Severe pain with potentially negative influence on the test results
* Psychiatric problems like alcohol dependence syndrome or Schizophrenia according to Diagnostic and Statistical Manual (DSM)®-5
* Regular use of drugs with potentially negative Influence on the test results with the exception of taking Benzodiazepines at night
* general anesthesia less than 3 months ago

Primary outcomes:
measure: Accuracy rate in emotion perception and perception of beliefs and intentions
timeFrame: 60 minutes
measure: Accuracy rate in perception of beliefs
timeFrame: 60 minutes
measure: Accuracy rate in perception of intentions
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marc Sollberger, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06527456: Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
Official title: Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 11200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.

Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.

This program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.

The intervention of the general practitioner, an essential player in prevention, could allow for better awareness.

The objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.

Detailed description: This is a cluster-randomized trial. Randomization will be performed at the GP practice level to limit the potential contamination bias between doctors within the same practice. GP practices will be randomized either to the 'usual practice' arm or the 'intervention' arm."

If they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, SMS, email, etc.), to encourage her to make an appointment to carry out the screening. Contact arrangements are left to the discretion of each general practitioner..

If they are in the "Usual practice" group, they will use their usual practices to encourage screening.

Eligibility criteria: Inclusion Criteria:

* Woman aged 25 to 65 living in Ile-De-France
* Eligible for DOCCU (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix)
* Having declared the investigating general practitioner as a treating physician (MT) and whose MT practices in the territory of a CPTS in the UPEC area
* Affiliate to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Patient already included in a study on DOCCU
* Patient excluded from organized screening (cervical cancer, hysterectomy).
* Patient's opposition to participating in the study

Primary outcomes:
measure: screening participation rate
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05917756: Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
Official title: The Impact of Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Outlet Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial with an equal allocation ratio (1:1) for the experimental and control groups
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to evaluate the effects of Mobilization with Movement (MWM) on pain, function, and quality of life in patients with Thoracic Outlet Syndrome (TOS) compared to conventional physiotherapy.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 years, diagnosed with TOS by a specialist, and experiencing symptoms for at least 3 months

Exclusion Criteria:

* Previous surgery for TOS
* contraindications to manual therapy
* other comorbidities significantly affecting upper limb function

Primary outcomes:
measure: Changes in Pain Intensity
timeFrame: Changes in Pain intensity at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Secondary outcomes:
measure: Changes in Functional Status
timeFrame: Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
measure: Changes in Cervical Range of Motion
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
measure: Changes in Quality of Life
timeFrame: Changes in quality of life at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)aseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References: