louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00915460: Open-Label Safety Extension Study of Avonex
Official title: An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Avonex
Interferon beta-1a
patients at high risk to develop multiple sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.


Eligibility criteria: Inclusion Criteria:

* Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
* Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.
* have not been diagnosed with any other disease that accounts for their neurologic symptoms.

Exclusion Criteria:

* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
* History of seizure within the 3 months prior to enrollment.
* Abnormal laboratory results at the screening visit:
* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.

Other inclusion and exclusion criteria apply as per Biogen Idec Protocol

Primary outcomes:
measure: The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
timeFrame: The study duration is 7 months
Secondary outcomes:
measure: To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.
timeFrame: The study duration is 7 months
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: STUDY_DIRECTOR
References:
Clinical trial NCT00868660: Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Official title: A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose

Detailed description: A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission

Eligibility criteria: Inclusion Criteria:

* Healthy adult male and/or females, 18 to 50 years of age
* Body mass index (BMI)18-30. Chrons Inclusion
* Adult male and/or females, 18 to 60 years of age (inclusive).
* Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
* Crohn's Disease Activity Index (CDAI) score \< 150.
* In a stable state of Crohn's disease as per the Investigator's opinion.
* Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.

Exclusion Criteria:

* History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
* Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.

Primary outcomes:
measure: safety and tolerability
timeFrame: January2009-January2010
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Jan 2009 - Jan 2010
Other outcomes:
Locations:
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
Study officials:
affiliation: Zealand Pharma A/S
name: Christian Thorkildsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT03544060: Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
Official title: Volanesorsen (ISIS 304801) Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Familial Chylomicronemia
Keywords: Familial Chylomicronemia
Familial Lipoprotein Lipase Deficiency
Hyperlipoproteinemias
Familial Hyperlipoproteinemia Type 1
Hyperlipoproteinemia Type 1
Hyperchylomicronemia, Familial
Lipoprotein Lipase Deficiency, Familial
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: CaligorRx, Inc.
First posted: 2018-06-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide expanded access to volanesorsen for up to 100 Patients with Familial Chylomicronemia Syndrome (FCS).

Detailed description: The Program is intended to provide expanded access to volanesorsen for eligible patients with FCS who have limited or no available treatment options.

Eligibility criteria: Inclusion Criteria:

* Patients who participated in the APPROACH Open Label trial, must have completed the open label extension trial for volanesorsen for a length of time consistent with the study protocol (≥ 1 year). Patients in the APPROACH open Label trial for less than a year require approval from Akcea to participate in the EAP. Patients who did not participate in the APPROACH open label trial require approval from Akcea for entry into EAP.
* Patients not participating in the APPROACH open label trial must have a diagnosis of FCS as determined by the participating physician, as outlined in the Volanesorsen EAP protocol. Akcea will review each application to determine eligibility.
* Male patients and female patients of childbearing potential must continue to use appropriate contraception with their partners, or refrain from sexual activity

Exclusion Criteria:

* Patients who have any new conditions or worsening of existing conditions which in the opinion of the Physician would make the patient unsuitable for treatment with volanesorsen.
* Volanesorsen naïve patients with baseline platelet values ≤ 140,000/mm3
* Patients not willing to adhere to mandatory blood draws for platelet monitoring
* Patients who in the opinion of Akcea's medical team, are not eligible candidates for volanesorsen therapy.
* Any patient who plans to or becomes pregnant.
* Any patient who was withdrawn from the APPROACH open label study due to a serious adverse event related to volanesorsen therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03083860: Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Official title: Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Brainmarc Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of 15-45 patients will be recruited in parallel and monitored for 4-6 weeks, than they will be followed for 4-6 weeks. They will receive feedback based on diary information and EEG.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with migraine by a neurologist.
* Male or Female, aged 18 -50 years.
* Having 3-10 migraine attacks per month.
* Able and willing to comply with all study requirements.
* Having Android based smartphone

Exclusion Criteria:

* Diagnosed with chronic pain, neurological or psychiatric disorders.
* Current or past use of anti-depressants.
* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
* History of seizures.
* Head injury with consciousness loss in the last three months.
* Diagnosed as ADHD and/or use of Ritalin.
* Hearing disorder and/or known eardrum impairment.
* Having migraine attacks occurring only during the menstruation.

Primary outcomes:
measure: Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
References:
Clinical trial NCT01141660: Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Official title: Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway
Tonsillectomy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 131
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.


Eligibility criteria: Inclusion Criteria:

* Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.

Exclusion Criteria:

* Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.

Primary outcomes:
measure: Number of Participants With Laryngospasm
timeFrame: 2 years
Secondary outcomes:
measure: Postanesthesia Recovery Times
timeFrame: After surgery
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virigina Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kelley Dodson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3. doi: 10.1093/bja/70.1.30.
Clinical trial NCT02921360: Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
Official title: Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Brain Ischemia
Keywords: thrombolytic therapy
tissue plasminogen activator
aspirin
Lead sponsor: City Clinical Hospital No. 67, Moscow, Russia
Sponsor class: OTHER_GOV
First posted: 2016-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether early administration of aspirin in acute ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes due to decreasing the number of early rethromboses.

Detailed description: According to the current guidelines (European Stroke Organisation, 2009; American Heart Association-American Stroke Association, 2013) on the systemic thrombolysis in ischemic stroke patients it is recommended (class C) to start antithrombotic therapy (including antiplatelets and anticoagulants) when 24 hours go after alteplase (rtPA, recombinant tissue plasminogen activator) administration. Meanwhile rtPA has wery short lifetime in blood (T1/2 4-6 minutes). Some retrospective studies have found that early administration of antithrombotics (8-16 hours) after systemic thrombolysis can improve functional outcome and does not increase the risk of haemorrhage.

The investigators suggest a controlled prospective trial to recognise risks and benefits of early administration of aspirin (in 12 hours) after rtPA therapy in patients with acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke patients treated with rtPA
* mRS score before current stroke \<4
* NIHSS score after rtPA treatment \<25

Exclusion Criteria:

* contraindications for treatment with aspirin
* contraindications fot iodinated radiocontrast agents administration
* intracranial haemorrhage after rtPA treatment

Primary outcomes:
measure: all cause mortality
timeFrame: 3 month
measure: ischemic events
timeFrame: 3 month
measure: haemorrhagic events
timeFrame: 7 days
Secondary outcomes:
measure: functional outcome
timeFrame: 3 month
measure: artery reocclusion
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: Amaro S, Llull L, Urra X, Obach V, Cervera A, Chamorro A. Risks and benefits of early antithrombotic therapy after thrombolytic treatment in patients with acute stroke. PLoS One. 2013 Aug 8;8(8):e71132. doi: 10.1371/journal.pone.0071132. eCollection 2013.
Clinical trial NCT00843960: Medication Adherence Enhancement in Heart Transplant Recipients
Official title: Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Self Management
Rejection
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.


Eligibility criteria: Inclusion Criteria:

* all eligible patients with follow-up at our outpatient clinic
* written informed consent
* sufficient German language skills to read and answer a battery of questionnaires
* \> 18 years
* minimum 6 mts post HTX

Exclusion Criteria:

* illiteracy

Primary outcomes:
measure: Occurrence of adverse events (composite endpoint)
timeFrame: at month 60
Secondary outcomes:
measure: Adherence behavior measurement variables from MEMS system
timeFrame: first 3 month
measure: Immunosuppression level
timeFrame: Month 3, 12 and 60
measure: All individual components of the composite endpoint occurence of adverse events
timeFrame: at month 60
measure: Immunosuppression level
timeFrame: month 12
measure: Immunosuppression level
timeFrame: at month 60
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Study officials:
affiliation: Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
name: Christiane Kugler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Clinical trial NCT01807260: Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis
Official title: STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Urinary Lithiasis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Detailed description: Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Eligibility criteria: Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Primary outcomes:
measure: Stone burden on plain X-ray.
timeFrame: Three months.
Secondary outcomes:
Other outcomes:
measure: Degree and presence of hydronephrosis.
timeFrame: Three months
measure: Stone burden on spiral computed tomography
timeFrame: Three months
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Erciyes University Medical Faculty,
state: Talas
Study officials:
affiliation: Department of Urology, Erciyes University Medical faculty,
name: Deniz Demirci, Prof.
role: STUDY_CHAIR
References:
citation: Demirci D, Altiok E, Gulmez I, Ekmekcioglu O, Poyrazoglu HM. Stepwise shock wave lithotripsy: results of initial study for the treatment of urinary stones in childhood. Int Urol Nephrol. 2006;38(2):189-92. doi: 10.1007/s11255-005-4971-x.
Clinical trial NCT00914160: To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: Anti-inflammatory
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Red River Clinic
name: Paul D. Larsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292160: Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance?
Official title: Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection Empiric Antibiotic
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 1128
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with an community-acquired urinary tract infection

Brief summary: The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified


Eligibility criteria: Inclusion Criteria:

* national health insurance card available
* community acquired urinary tract infection

Exclusion Criteria:

* incapacity to accept an inform consent
* hospitalized acquired urinary tract infection
* national health insurance card non available

Primary outcomes:
measure: Frequency of antibiotic resistant organisms
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Elbeuf
country: France
facility: Lbmr de Normandie
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: UH Rouen
name: Francois CARON, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandre K, Reveillon-Istin M, Fabre R, Delbos V, Etienne M, Pestel-Caron M, Dahyot S, Caron F. Temocillin against Enterobacteriaceae isolates from community-acquired urinary tract infections: low rate of resistance and good accuracy of routine susceptibility testing methods. J Antimicrob Chemother. 2018 Jul 1;73(7):1848-1853. doi: 10.1093/jac/dky101.