louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02565940: Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Infection
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diabetic patient with foot infection

Brief summary: This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

Detailed description: Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics

Eligibility criteria: Inclusion Criteria:

* Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) \[IWGDF, Lipsky Clin Infect Dis on 2004\], inaugural or récidivante.

Exclusion Criteria:

* The patient participates in another study
* The patient is in period of exclusion determined by a previous study
* The patient is under protection(saving) of justice, under guardianship or under guardianship
* The patient refuses to sign the consent
* It turns out impossible to give about the lit(enlightened) information
* The patient is pregnant, parturiente, or she breast-feeds
* The patients having no wound
* The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) \[IWGDF, Lipsky Clin Infect Dis on 2004\]

Primary outcomes:
measure: dermal sample
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
state: Paca
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: desalbres urielle
role: STUDY_DIRECTOR
References:
Clinical trial NCT00267540: The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
Official title: Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
adolescent girls
bone accretion
bone turn over
vitamin D status
Vitamin D insufficiency in young girls
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Seventh Framework Programme
First posted: 2005-12-21
Enrollment: 225
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.

More specifically the effects on the following parameters will be assessed:

* Vitamin D metabolites.
* Parathyroid hormone.
* Bone turnover.
* Bone mineral accretion.
* Serum calcium and phosphate.
* Renal handling of calcium and phosphate.

Detailed description: This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.

Eligibility criteria: Inclusion Criteria:

* Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg

Exclusion Criteria:

* Any chronical disease with influence on bone mass or turnover
* Intake of drugs with influence on bone mass or turnover
* Intake of calcium or vitamin D other than the intervention

Primary outcomes:
measure: Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
measure: Bone accretion measured by DXA. Measurement at baseline and after one year.
measure: Bone turnover measured at baseline, half a year and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, The Royal Veterinary and Agricultural University
Study officials:
affiliation: The Royal Veterinary and Agricultural University, Frederiksberg, Denmark
name: Christian Mølgaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.
Clinical trial NCT01238640: Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
Official title: Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Detailed description: The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: During 10 hours post-dose
measure: Area Under the Curve [AUC(0-t)]
timeFrame: During 10 hours post-dose
measure: AUC(0-∞)
timeFrame: 10 hours post-dose
Secondary outcomes:
measure: Product Dissolution Time
timeFrame: During 10 hours post-dose
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03581240: An Intermediate Expanded Use Trial of DFMO
Official title: An Intermediate Expanded Use Trial of DFMO
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Neuroblastoma
Medulloblastoma
Typical Teratoid Rhabdoid Tumor
Embryonal Tumor With Abundant Neuropil and True Rosettes
Ependymoblastoma
Medulloepithelioma
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: K C Pharmaceuticals Inc.
name: USWM, LLC
First posted: 2018-07-10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT

Brief summary: To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.


Eligibility criteria: Inclusion Criteria:

* Age: 0-30 years at the time of initial diagnosis.
* Diagnosis: Histologic verification at either the time of original diagnosis or a previous relapse of High Risk neuroblastoma, medulloblastoma, atypical teratoid rhabdoid tumor, embryonal tumor with abundant neuropil and true rosettes, ependymoblastoma, medulloepithelioma and other rare pediatric MYC, ODC or LIN28/Let7 driven tumors (each type will form a new subset).
* Disease Status: Subjects must be in one of the following disease categories:

  1. High risk neuroblastoma patients that have completed standard of care upfront therapy and are not eligible for NMTRC014.
  2. Medulloblastoma patients who have completed standard of care therapies.
  3. Relapsed/refractory neuroblastoma patients who have completed standard of care therapies.
  4. Rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase who have completed standard of care therapies.
* Subjects are not eligible to enroll on DFMO studies NMTRC002, NMTRC003, NMTRC010, or NMTRC014.
* A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).
* Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
* Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

* BSA (m2) of \<0.25
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center and Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Beat Childhood Cancer
name: Giselle Sholler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02066740: EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Official title: EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Diseases
Keywords: Superficial Femoral Artery
Proximal Popliteal Artery
Everflex
Entrust
stent
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.


Eligibility criteria: Inclusion Criteria:

* Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
* or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion Criteria:

* Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

Primary outcomes:
measure: Absence of Stent Elongation
timeFrame: Intra operative
measure: Successful Stent Deployment
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Weiden
country: Germany
facility: Klinikum Weiden
Study officials:
affiliation: Karolinska University Hospital
name: Carl M Wahlgren, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765140: Treatment Use of 3,4-Diaminopyridine
Official title: Treatment Use of 3,4-Diaminopyridine in Congenital Myasthenic Syndrome
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Myasthenic Syndromes, Congenital
Keywords: 3,4 diaminopyridine (DAP)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This protocol provided 3,4 diaminopyridine (DAP) under a treatment-use IND to patients with congenital myasthenic syndrome (CMS). It is now closed.

Detailed description: CMS diagnoses were made based on clinical, electrophysiologic and molecular genetic findings. All patients were referred to the PI for DAP treatment. This study enrolled minors and adults.

CMS patients under age 18 years were included if their parent or guardian gave written permission. Minors who turned 18 while in the program were re-consented as adults.

The dose of DAP was determined individually for each patient. Adults were started with a dose of 10 mg 3-4 times daily, increased over several weeks to the dose that produced the maximum symptomatic response, not to exceed 100 mg daily. Pyridostigmine bromide (PB) was often added at low doses and increased to the dose that produced the best response, not to exceed 360 mg daily. In children, equivalent doses of these medications were calculated on a surface area basis. The doses of DAP and PB were periodically adjusted to assure that the smallest effective doses are used.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital myasthenic syndrome (CMS)
* Women of childbearing potential must have negative pregnancy test and agree to practice adequate contraception while taking DAP
* Must be competent to give consent

Exclusion Criteria:

* Known seizure disorder
* Pregnancy
* Known cardiac arrhythmia or evidence of significant arrhythmia on screening ECG
* Known hepatic, renal or hematologic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Vern C. Juel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanders DB, Juel VC, Harati Y, Smith AG, Peltier AC, Marburger T, Lou JS, Pascuzzi RM, Richman DP, Xie T, Demmel V, Jacobus LR, Ales KL, Jacobus DP; Dapper Study Team. 3,4-diaminopyridine base effectively treats the weakness of Lambert-Eaton myasthenia. Muscle Nerve. 2018 Apr;57(4):561-568. doi: 10.1002/mus.26052. Epub 2018 Feb 2.
Clinical trial NCT03171740: Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children
Official title: Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Emergence Delirium
Keywords: Emergence Delirium
Emergence Agitation
premedication
dexmedetomidine
midazolam
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.
Primary purpose: PREVENTION

Brief summary: Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.

Detailed description: Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.

Eligibility criteria: Inclusion Criteria:

* Scheduled for amygdalectomy
* American Society of Anesthesiologists Physical Status PI or PII
* Absence of congenital neuropathy
* Absence of cardiac pathology (any)
* Intolerance to one of the studied drugs.

Exclusion Criteria:

* Protocol violation
* Need to transfer for ICU intubated

Primary outcomes:
measure: Emergence agitation
timeFrame: 15 minutes
Secondary outcomes:
measure: Bradycardia
timeFrame: 2 hours
measure: Hypotension
timeFrame: 2 hours
measure: Intraocular pressure
timeFrame: 15-minutes
measure: Respiratory depression
timeFrame: 30 minutes
measure: Paradoxal agitation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasilia University
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Gabriel MN Guimarães, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06482840: Safety and Efficacy of EasyCool Catheter
Official title: Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Arrhythmia
Keywords: EasyCool Catheter
cardiac ablation
Lead sponsor: MedFact Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intracardial RF-Ablation procedure at following indications:

* Atrial Tachycardia

  * Tricuspid istmus flutter
  * Atypical flutter
  * Focal atrial tachycardia
  * Atrial fibrillation
* AV-node re-entrant tachycardia;
* Tachycardia heart rhythm disturbances associated with accessory pathways;
* Ventricular Tachycardia.

Brief summary: The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias.

The main question\[s\] it aims to answer are:

* will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
* what are the adverse events at procedure, after 3 and 6 months

All participants will receive cardiac ablation with EasyCool catheter.


Eligibility criteria: Inclusion Criteria:

* Patients requiring intracardial RF- Ablation with irrigated catheter

Exclusion Criteria:

* Absence of patient´s consent;
* Age \<12 years;
* Pregnancy or breast-feeding women;
* Acute local infection;
* Acute systemic infection;
* Atrial thrombosis or myxoma - the transseptal approach is contraindicated in patients with left atrial thrombus;
* Existence of active Implants (Pacemaker, Defibrillator etc.);
* Hemodynamic instability;
* Hypercoagulability;
* Inadequate tissue damaged e.g. by radiation or suppuration;
* Obstruction of the artery or vein selected for insertion;
* Patients with artificial heart valve: the use of intracardial catheters is not advised;
* Physiologic or anatomic abnormalities that could cause postoperative complications e.g. aneurysms in the application area, bleeding diathesis, decreased resistance to infections;
* Previously diagnosed spasms of the coronary arteries;
* Recurrent metastasizing cancer;
* Sepsis;
* Severe concomitant illness for which an increase or surgery time is associated with a significant increased risk;
* Thrombosis of the leg veins and the deep pelvic vein.

Primary outcomes:
measure: Removal of treated cardiac arrythmia
timeFrame: 3 months after procedure
Secondary outcomes:
measure: Adverse Events
timeFrame: at procedure, after 3 and 6 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Centre Hospitalier International de Carthagène
state: Centre Urbain Nord
Study officials:
affiliation: Centre Hospitalier International de Carthagène, Tunisia
name: Abdeddayem Haggui, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723840: Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560)
Official title: Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Keywords: EuroQOL (EQ-5D)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's Disease for at least 6 months who have active disease despite drug therapy and are seen at one of 25 gastroenterology centers spread across Italy.

Brief summary: This observational study will evaluate the social cost and quality of life of participants who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Participants are followed for a total of 18 months.

Detailed description: Participants for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 participants each.

Eligibility criteria: Inclusion Criteria:

* participant must:

  * be between 18 and 70 years of age,
  * have active Crohn's disease (CD) with CDAI score \>= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease,
  * be diagnosed with CD for at least 6 months,
  * sign the informed consent,
  * be capable of understanding the study and replying to the questionnaires.

Exclusion Criteria:

* Participants who are unreliable in filling out questionnaires,
* Participants with diseases which may interfere with the cost's of CD or its complications,
* Participants who are participating in a clinical trial

Primary outcomes:
measure: Cost of Illness in Participants With Crohn's Disease
timeFrame: Baseline, 6, 12, and 18 months
measure: EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease
timeFrame: Baseline, 6, 12, and 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Benedini V, Caporaso N, Corazza GR, Rossi Z, Fornaciari G, Cottone M, Frosini G, Caruggi M, Ottolini C, Colombo GL. Burden of Crohn's disease: economics and quality of life aspects in Italy. Clinicoecon Outcomes Res. 2012;4:209-18. doi: 10.2147/CEOR.S31114. Epub 2012 Jul 24.