louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03594084: Malaria in Strasbourg University Hospital
Official title: Retrospective Clinical Study of Malaria in Strasbourg University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Keywords: Malaria
Malaria imported cases
Recurrent malaria
Endemic malaria areas
Biological diagnosis
Hospital vs private laboratory diagnosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: iagnosis patients with malaria from 01/01/2017 to 01/01/2018

Brief summary: The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively


Eligibility criteria: Inclusion Criteria:- Patient over 18 years

* Patients from birth to 18 years
* Patient submitted to guardianship
* Patient submitted to trusteeship
* Diagnosis patients with malaria from 01/01/2017 to 01/01/2018
* Patient or legal representative agree to use medical data for this research

Exclusion Criteria:

* Lack of confirmation malaria diagnosis
* Impossibility to inform patients
* Patient who does not wish to participate in the study
* Patient submitted to justice safeguarding

Primary outcomes:
measure: Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018.
timeFrame: The period from January 1st, 2017 to January 1st, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Maladies Infectieuses et Tropicales
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Xavier ARGEMI, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01113684: Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)
Official title: Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-04-30
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease who have undergone subthalamic deep brain stimulation

Brief summary: Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson disease who have undergone subthalamic deep brain stimulation

Exclusion Criteria:

* Patients who are unable to follow verbal instructions
* Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
* Patients who are medically unstable

Primary outcomes:
measure: This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease.
timeFrame: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham, Department of Neurology
name: Harrison C Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker HC, Watts RL, Guthrie S, Wang D, Guthrie BL. Bilateral effects of unilateral subthalamic deep brain stimulation on Parkinson's disease at 1 year. Neurosurgery. 2009 Aug;65(2):302-9; discussion 309-10. doi: 10.1227/01.NEU.0000349764.34211.74.
Clinical trial NCT05061784: Routine Transcervical Thymectomy in MEN-1 Patients
Official title: Revisiting the Evidence for Routine Transcervical Thymectomy for the Prevention of Thymic Carcinoid Tumours in MEN-1 Patients a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Endocrine Neoplasia Type 1 (MEN-1)
Thymic Carcinoid
Keywords: Routine transcervical thymectomy
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.

Brief summary: A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.

Detailed description: Introduction and Importance Malignant thymic carcinoids are uncommon but important entities among patients with multiple endocrine neoplasia type 1 (MEN-1). Current treatment guidelines advise the performance of a routine transcervical thymectomy (TCT) during parathyroidectomy, to prevent its development, although data on the yield of this prophylactic TCT is scarce. We aimed to revisit available literature to investigate and summarize the efficacy of routine TCT during neck exploration for parathyroidectomy, for the prevention of thymic carcinoid tumours among MEN-1 patients.

Methods A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.

Eligibility criteria: Inclusion Criteria:

* Studies including MEN-1 patients who underwent a routine thymectomy during parathyoidectomy

  * We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.

Exclusion Criteria:

* We excluded reviews, letters, conference proceedings and non-English publications.

Primary outcomes:
measure: Incidence of thyme carcinoid
timeFrame: The timeframe will be from date of transcervical thymectomy until the date of documented diagnosis of diagnosis of thymic NET; progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT02997384: Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
Official title: Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastcancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women 40 to 74 years seen in consultation by their attending physician, gynecologist or radiologist

Brief summary: This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.


Eligibility criteria: Inclusion Criteria:

* Woman from 40 to 74 years old
* Understanding the French language

Exclusion Criteria:

Women will not be eligible for study if they are in any of the following situations:

* Cancer active or in the course of treatment type surgery, chemotherapy, or radiotherapy, whether breast or other organ
* Recent diagnosis \<1 year of suspicious or cancerous lesions
* Psychiatric pathology not compatible with the study
* Poor understanding of the French language

Primary outcomes:
measure: Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
References:
Clinical trial NCT01442584: Transplantation of Ovarian Cortex to Restore Fertility
Official title: Transplantation of Ovarian Cortex to Restore Fertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: ovary
cortex
transplantation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 5
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ovarian transplantation has been shown to restore fertility.

Detailed description: The investigators transplant ovarian cortex previously collected from the patient prior to cancer treatment.

Eligibility criteria: Inclusion Criteria:

* patients who froze ovarian tissue

Exclusion Criteria:

* malignant cells in ovary

Primary outcomes:
measure: pregnancy
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah
Study officials:
affiliation: Hadassah
name: Ariel Revel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01339884: A Study of Resveratrol as Treatment for Friedreich Ataxia
Official title: An Open Label Clinical Pilot Study of Resveratrol as Treatment for Friedreich Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Friedreich Ataxia
Keywords: Friedreich ataxia
Resveratrol
Frataxin
Cardiomyopathy
Oxidative stress
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Friedreich's Ataxia Research Alliance
First posted: 2011-04-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of two doses of resveratrol taken for a 12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will also measure the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia, and cardiac parameters.

Detailed description: Resveratrol shows promise as an agent for the treatment of Friedreich ataxia due to its antioxidant properties, neuroprotective effects, and ability to increase frataxin levels in vitro and in vivo. This clinical pilot study aims to determine the effect of two doses of resveratrol (1g/day and 5g/day) taken for 12 weeks, on frataxin levels in individuals with Friedreich ataxia. Additional outcome measures include the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia , and cardiac parameters (including relative wall thickness and left ventricular mass index).

Eligibility criteria: Inclusion Criteria:

* Adults with Friedreich ataxia due to homozygosity for the GAA repeat expansion in intron 1 of the FXN gene
* Functional stage on the Ataxia subscale of the FARS of 1 or higher

Exclusion Criteria:

* Women who are pregnant or lactating
* Active arrythmias or significant cardiac insufficiency
* Use of idebenone, Coenzyme Q or vitamin E within 30 days prior to enrolment
* Use of amiodarone or other medications which may have clinically significant drug interactions that cannot be safely monitored

Primary outcomes:
measure: Lymphocyte frataxin level
timeFrame: 12 weeks
Secondary outcomes:
measure: Oxidative stress markers
timeFrame: 12 weeks
measure: Clinical rating scales of ataxia
timeFrame: 12 weeks
measure: Echocardiogram measures
timeFrame: 12 weeks
measure: Pharmacokinetic studies of resveratrol
timeFrame: First 2 hours post dose
Other outcomes:
Locations:
city: Clayton, Melbourne
country: Australia
facility: Monash Medical Centre, Southern Health
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Martin Delatycki, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01309984: A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure
Official title: An Open-label, Single Initial-dose, Multi-center Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lactating Women
Keywords: Monitored anesthesia care
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.

Detailed description: E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.1 It is a water-soluble, phosphono-O-methyl prodrug of propofol. Upon IV injection, the inactive fospropofol undergoes metabolism, most notably by alkaline phosphatase enzymes, to yield the active metabolite (propofol), phosphate, and formaldehyde. Formaldehyde is quickly converted to formate in vivo, and formate is further metabolized by a folate-dependent mechanism.

Eligibility criteria: Inclusions:

* Lactating women undergoing a needed procedure expected to last between approximately 10 to 45 minutes
* Subjects should be between 6 weeks and 8 months postpartum
* Lactation must be well-established in subjects
* Subject's infants must be full term and able to bottle-feed
* Infants should be predominantly breast milk fed and should not receive more than one bottle of formula per day

Exclusions:

* Subjects who are pregnant
* Subjects undergoing a breast procedure (eg, biopsy, abscess drainage, etc.)
* Subjects who are not willing to temporarily refrain from nursing their children during the 0-24 hour breast milk collection interval.

(Subjects may resume nursing following this interval).

Primary outcomes:
measure: Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours.
timeFrame: 24 hours
measure: Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours
timeFrame: 24 hours
measure: The fraction (%) of the maternal dose transferred to breast milk in 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Eisai Inc.
name: Christa Nagy
role: STUDY_DIRECTOR
References:
Clinical trial NCT02102984: Covered Versus Uncovered Biliary Stents for Biliary Malignancies
Official title: Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Cancer
Keywords: distal malignancy of the extra-hepatic biliary tract
metallic biliary stents
covered biliary stents
uncovered biliary stents
Lead sponsor: Nuovo Ospedale Civile S.Agostino Estense
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.

Detailed description: Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.

Eligibility criteria: Inclusion Criteria:

* adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
* not eligible for surgical intervention
* able to provide informed consent

Exclusion Criteria:

* benign biliary obstruction
* previous surgery of the biliary tract
* life expectancy \< 3 months

Primary outcomes:
measure: Relief of malignant biliary obstruction
timeFrame: six months
Secondary outcomes:
measure: cost/effecacy
timeFrame: 6 months
Other outcomes:
measure: gallbladder in situ
timeFrame: 6 months
Locations:
city: Modena
country: Italy
facility: NOCSAE - Viale Giardini 1355
Study officials:
affiliation: Digestive Endoscopy Unit-NOCSAE- Modena
name: Rita Conigliaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078.
citation: Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11.
Clinical trial NCT01108484: Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
Official title: Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Keywords: Cancer survivors, exercise, diet, emotional support
Lead sponsor: Grupo de Investigación en Actividad Física y Salud
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.

Detailed description: Cancer survivors will be randomised to one of the following groups: a) Supervised physical activity, b) Supervised physical activity + Diet counseling, c) Supervised physical activity + Diet counseling + psycho-emotional support

Eligibility criteria: Inclusion Criteria:

* cancer survivors attending their follow-up visits

Exclusion Criteria:

* Cardiac disease NYHA II
* non-controlled hypertension
* non-controlled metabolic disease
* chronic infectious disease
* non-controlled pain
* risk of bone fracture
* severe anemia, leucopenia or thrombopenia

Primary outcomes:
measure: VO2 max
timeFrame: basal, 6, 12 and 24 months
Secondary outcomes:
measure: Physical Activity Quality of life Food intake Anxiety and Psychological Distress
timeFrame: basal, 6, 12 and 24 months
Other outcomes:
Locations:
city: Miranda de Ebro
country: Spain
facility: GIAFYS headquarters
state: Burgos
city: Miranda de Ebro
country: Spain
facility: GIAFYS
state: Burgos
Study officials:
affiliation: Grupo de Investigación en Actividad Física y Salud
name: Fernando Herrero-Roman, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00380484: Short- and Long Term Growth in Children With Asthma
Official title: Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Children´s Clinic, Randers
Sponsor class: OTHER
First posted: 2006-09-26
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma

Detailed description: When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.

Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.

Eligibility criteria: Inclusion Criteria:

* age 6-11,
* prepubertal,
* asthma,
* normal weight and height,
* informed consent

Exclusion Criteria:

* treatment with systemic/inhaled/intranasal corticosteroids within the last week,
* major surgery within 4 weeks,
* usage of drugs that significantly inhibit CYP3A4

Primary outcomes:
measure: Lower leg growth rate
timeFrame: one year
measure: Height
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Children's Clinic Randers
Study officials:
affiliation: Children's Clinic Randers
name: Ole D Wolthers
role: PRINCIPAL_INVESTIGATOR
References: