louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01089855: Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain
Official title: Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Neuropathic Pain
Brief Pain Inventory
DN4 questionnaire
ElectroCardioGram
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients


Eligibility criteria: Inclusion Criteria:

* Diabetes patients with Diabetes neuropathy DN4 \> or equal to 4
* Male or female aged from 21 to 65 years
* Informed consent
* HbA1C \< 11%

Exclusion Criteria:

* Prior Hospitalization for Acido- cetosis
* Prior hospitalization for severe hypoglycemia
* Pregnancy
* Hepatitis
* Diabetes foot
* AVB (auriculo-ventricular conduction disturbance)
* Patient treated by antidepressant drugs
* Patient treated with other antiepileptic drug
* Patients with blood ion disturbance
* Patient with neutropenia
* Glaucoma
* Bladder Adenoma
* Alcohol abuse
* Creatinin clearance \< 60 ml/ minute

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)
timeFrame: 12 weeks
measure: Evaluate the quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05139355: Health Effects of Oat and Oat Polar Lipids in Human
Official title: Health Effects of Oat and Oat Bioactive in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose Regulation
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Foundation for Strategic Research
First posted: 2021-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

Detailed description: The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* BMI 18.5 - 28 Kg/m2
* Non smokers
* Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/l
* Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome).
* Gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies.
* No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Primary outcomes:
measure: Blood glucose regulation
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary outcomes:
measure: Serum insulin
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: plasma GLP-1 (glucagon-like peptide-1 )
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Serum triglycerides
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Serum Free Fatty Acids
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Plasma PYY (peptide tyrosine tyrosine)
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Other outcomes:
measure: Subjective appetite sensations
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Locations:
city: Lund
country: Sweden
facility: Food Technology, engineering and Nutrition, LTH, Lund University
Study officials:
affiliation: Department of Food Technology, Engineering and Nutrition, Lund Univesity
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00034814: Multicenter Trial for Adults With Partial Seizures
Official title: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.

Detailed description: A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.

Eligibility criteria: Inclusion Criteria:

* must weigh greater than or equal to 40kg
* Patients must have diagnosis of partial seizures
* At least 3 observable partial seizures a month
* Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.

Exclusion:

* Patients on Valproic acid, and Felbamate

Primary outcomes:
measure: Reduction in frequency of partial seizures
timeFrame: 12 weeks
Secondary outcomes:
measure: The number of seizure-free days and percent responders
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00363714: A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: Sirna Therapeutics Inc.
First posted: 2006-08-15
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.


Eligibility criteria: Inclusion Criteria:

* Active AMD with Subfoveal CNV (classic and/or occult CNV)
* CNV lesion thickness \>/= 250um by OCT assessment
* Visual acuity in study eye of \</= 20/100 but not worse than 20/800
* Not eligible for or refused standard treatment

Exclusion Criteria:

* Females of childbearing potential
* Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
* Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry
* CNV lesion \>/= 12 MPS disc area

Primary outcomes:
measure: Adverse Events
timeFrame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84
Secondary outcomes:
measure: Visual Acuity using the Diabetic Retinopathy Study chart
timeFrame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
measure: IOP
timeFrame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
measure: OCT
timeFrame: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
measure: Fluorescein Angiography (FA)
timeFrame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Cleveland
country: United States
state: Ohio
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kaiser PK, Symons RC, Shah SM, Quinlan EJ, Tabandeh H, Do DV, Reisen G, Lockridge JA, Short B, Guerciolini R, Nguyen QD; Sirna-027 Study Investigators. RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. Am J Ophthalmol. 2010 Jul;150(1):33-39.e2. doi: 10.1016/j.ajo.2010.02.006.
Clinical trial NCT00523614: Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
Official title: Use of OCs Containing Dienogest and Risk of Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: venous thromboembolism
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-08-31
Enrollment: 3400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007

Controls: population sample

Brief summary: The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral contraceptives with non-use, focusing specifically on Valette® compared to other users of low estrogen dose combined oral contraceptives.

Detailed description: This is a population-based case-control study in Germany.

Cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December 2007.

Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4 controls matched by year of birth and region will be allocated to each case.

Both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls.

Study participants will be asked for their informed consent. Data confidentiality will be ensured by the Berlin Center for Epidemiology and Health Research.

Eligibility criteria: Inclusion Criteria:

* cases: women with a venous thromboembolism who are between 15 and 49 years old
* control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old

Exclusion Criteria:

* women outside the defined age range
* women with severe language problems
* women who are not willing to participate

Primary outcomes:
measure: Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)
timeFrame: 01/2002 - 01/2008
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemilogy and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research
name: Juergen C Dinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963255: Outcomes of Arterial Allografts Preserved at +2 to +8°C for Revascularization in Septic Settings
Official title: Résultats Des Allogreffes artérielles conservée à +2/+8°C Dans Les REvascularisations en MIlieu Septique
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Revascularization in a Septic or Potentially Septic Environment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population includes all patients requiring bypass revascularization in a septic or high-risk septic environment, for whom a biomaterial is preferred over a prosthetic graft due to the unavailability of the patient's autologous saphenous vein

Brief summary: This study does not modify patient management or treatment. All patients undergoing treatment with an arterial allograft preserved at +2/+8°C as part of an arterial revascularization in a septic environment in either of the two centers between January 2024 and January 2025 will be included.

Imaging exams and clinical follow-up data will be analyzed. Reinterventions and causes of death will be recorded. All imaging required for the 6-month follow-up is routinely performed as part of standard care. No modification of patient management is planned.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Requiring revascularization in a septic or high-risk septic environment
* With an estimated life expectancy of 12 months or more based on medical and surgical assessment
* Informed about the study

Exclusion Criteria:

* Pregnant women
* Individuals for whom regular medical follow-up cannot be ensured

Primary outcomes:
measure: To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bron
country: France
facility: HCL hopital Louis Pradel
Study officials:
References:
Clinical trial NCT00765414: Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.
Official title: An Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) Given as Enyzme Replacement Therapy to a Single Patient With Pompe Disease (Glycogen Storage Disease Type II) Who Were Previously Enrolled in Genzyme-Sponsored Enzyme Replacement Therapy Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pompe Disease Late-Onset
Glycogen Storage Disease Type II GSD II
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 1
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme study.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent prior to participating in any study related procedures;
* Currently enrolled in Protocol AGLU01402
* Have the ability to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time.

Exclusion Criteria:

* Was pregnant or unwilling to use approved birth control during the course of the study;
* Had experienced any unmanageable AEs under Protocol AGLU01402 (as determined and agreed upon by the Principal Investigator and sponsor) due to rhGAA that would preclude continuing ERT;
* Was participating in any other investigational study.

Primary outcomes:
measure: The objective of this extension study was to monitor the long-term safety and efficacy of a single patient
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00214214: A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus
Official title: A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: New Onset Type 1 Diabetes Mellitus
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The rationale for the study is to determine if Campath-1H can be used in patients recently diagnosed with type I DM, to induce a state of immunological unresponsiveness such that subjects can safely preserve beta cell mass and eliminate or lower insulin requirements, preserving excellent metabolic control.


Eligibility criteria: Inclusion Criteria:

* Adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to GAD, IA2, IAA or islet cell cytoplasmic antibody (ICA) within 2 weeks of diabetes diagnosis.

Exclusion Criteria:

* Subjects under 18 years of age or over 35 years of age.
* Subjects who have previously received an organ transplant.
* Subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
* Subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., Cushing's disease, acromegaly).
* Subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (A history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
* Patients with a history of hepatitis B, hepatitis C, or HIV.
* PPD positive at the time of evaluation.
* Thrombocytopenia or neutropenia. Individuals will be considered to have thrombocytopenia if they have a platelet count \<100,000 platelets/mm2 or \<3,000 WBC/ml.
* Subjects with a history of renal, pulmonary, or cardiac failure
* Subjects with severe systemic infections. Only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.

Primary outcomes:
measure: to determine if Campath-1H can be used in patients recently diagnosed with type I DM
Secondary outcomes:
measure: to determine if Campath-1H can eliminate or lower insulin requirements
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Luis Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151514: Referral Patterns for Hospital Acquired Acute Kidney Injury and Relevance to Renal Outcomes
Official title: Referral Patterns for Hospital Acquired Acute Kidney Injury and Relevance to Renal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Replacement Therapy
Mortality
Keywords: No referral
Late referral
Acute kidney injury
Intensive care unit
In-hospital mortality
Renal outcome
Requirement for renal replacement therapy
Length of hospital stay
Impact
Incidence
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2010-06-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study population consisted of patients who were hospitalized in the medical and surgical departments as well as in the intensive care untis (ICU) of the University Hospital of Lausanne (Centre Hospitalier Universitaire Vaudois \[CHUV\]) that is a tertiary care academic medical center. Patients with AKI coming from ICU in the medicine or surgery wards, and patients from medicine or surgery wards, who required a transfer to ICU during the hospital stay, were also included whatever the cause of the transfer.

Brief summary: Few studies analyzed the referral time to nephrologists and its impact on the patient outcome in a large cohort. The investigators described the incidence and determined the outcome with respect to renal function recovery, renal replacement therapy (RRT) requirement and in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared with early referral patients (erHA-AKI). The patients included were admitted to the tertiary care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and surgical services and in the intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

* Adult patients.
* Hospitalization in the medicine and surgery wards and in the intensive care unit.
* Hospitalized patients with acquired acute kidney injury according to the
* Acute Kidney Injury Network (AKIN)criteria.
* HA-AKI patients with no referral to the nephrologist (nrHA-AKI).
* HA-AKI patients referred late (more than five days \[\> 5 days\]) to the nephrologist (lrHA-AKI).
* HA-AKI patients early referred (within five days after sCr increase) to the nephrologist (erHA-AKI).

Exclusion Criteria:

* Patients with AKI at the time of the hospital admission and during the first
* 48 hours after admission.
* Patients hospitalized in other wards.
* Children under 18.

Primary outcomes:
measure: Referral patterns for hospital acquired acute kidney injury and relevance to renal outcomes
Secondary outcomes:
measure: Referral patterns for hospital acquired acute kidney injury and relevance to renal outcomes
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Nephrology - CHCVs
Study officials:
References: