louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01129531: A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 294
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: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.


Eligibility criteria: Inclusion Criteria:

* Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

Exclusion Criteria:

* Female patients with reproductive potential
* Active herpes zoster skin rash
* Current or anticipated treatment with acupuncture, TNS, or steroids
* Current or anticipated use of topical analgesic agents with PHN
* Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks

Primary outcomes:
measure: Change From Baseline in the Average Pain Intensity Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Area of Spontaneous Pain
timeFrame: Baseline, Week 12
measure: Change From Baseline in Area of Allodynia
timeFrame: Baseline, Week 12
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
city: Brno
country: Czech Republic
city: Kiel
country: Germany
city: Katowice
country: Poland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03452631: Spontaneous Haematomas of Psoas Occurring in Intensive Care
Official title: Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoas Hematomas
Keywords: Psoas hematomas
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with psoas hematoma diagnosed during hospitalization

Brief summary: Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Psoas hematoma diagnosed during hospitalization

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Number of psoas hematomas
timeFrame: 72 hours after admission to intensive care
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation médicale
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Julie HELMS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05528731: Perception of Female Hormonal Contraception by the Main Prescribers
Official title: Perception of Female Hormonal Contraception by the Main Prescribers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Hormonal Contraception
Keywords: Female Hormonal Contraception
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any health care professional in general medicine, gynecology and midwifery, graduate or in progress in practice (any practice modality in metropolitan France)

Brief summary: The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment.

Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.


Eligibility criteria: Inclusion criteria:

* Any health care professional in general medicine, gynecology and midwifery
* graduate or in progress
* in practice (any practice modality in metropolitan France)
* agreeing to participate in the survey by completing the questionnaire anonymously, after having read the information and non-objection notice attached to the questionnaire.

Exclusion criteria:

- Any other health profession

Inclusion criteria:

- Any health care professional in general medicine, gynecology and midwifery

Primary outcomes:
measure: Study of the perception of risks and management of adverse effects of hormonal contraception among prescribers
timeFrame: 5 months after interviews with prescribers
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02909231: One-year Patient Reported Outcomes Following Hospitalization for Trauma
Official title: One-year Patient Reported Outcomes Following Hospitalization for Trauma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds and Injuries
Keywords: Patient Outcome Assessment
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
name: University of British Columbia
First posted: 2016-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults admitted to the trauma service at either of the two level I trauma centres in Western Canada (Vancouver General Hospital, Vancouver, BC and Foothills Medical Centre, Calgary, AB) over a four month period.

Brief summary: This study evaluates the three, six, and twelve month patient reported outcomes of people admitted two trauma centres in western Canada over a four month period. Participants are evaluated using the Trauma Outcome Profile and a custom survey instrument.

Detailed description: This study intends to assess patient reported outcomes following discharge from trauma services at the Foothills Medical Centre (FMC) and Vancouver General Hospital (VGH). The investigators will survey participants with pen-and-paper surveys at three, six and twelve months following discharge from hospital. The survey instrument being used is the Trauma Outcomes Profile, which has been previously validated in this population, supplemented by a supplemental survey to help further describe resources this population has access to in their recovery. The results of these surveys will be compared with pre-injury health status, injury types, mechanisms, and discharge medications and treatments. The investigators anticipate enrolling 500 participants starting in October 2016. At the conclusion of the study the investigators will have a better understanding of patient reported functional outcomes after trauma and will be better positioned to design trauma rehabilitation systems to service this population.

Eligibility criteria: Inclusion Criteria:

* admitted to the trauma service at VGH or FMC
* Age 18 or older
* resident of Canada

Exclusion Criteria:

* English language literacy
* Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey
* No fixed address

Primary outcomes:
measure: Medium-term health-related quality of life
timeFrame: Up to one year
Secondary outcomes:
measure: Local resource use for trauma patients admitted to hospital
timeFrame: Up to one year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of Calgary
name: Chris Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508231: Metabolic Consequences of Cross-sex Hormonal Treatment
Official title: Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the out-patient clinic at our department of endocrinology

Brief summary: Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls


Eligibility criteria: Inclusion Criteria (retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. All measurements were made at the time of the routine follow-up visits)

* age \>= 16 years (Tanner stage IV) and \<= 50 years at the initiation of gender-affirming hormone therapy;
* BMI \< 28 kg/m2 at the initiation of cross-sex hormonal treatment.

Exclusion Criteria:

* hormonal contraception
* previous gender-affirming hormonal treatment
* previous gender-affirming surgery
* recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.

Primary outcomes:
measure: Retrospective analysis of existing data collected as a part of the regular follow-up
timeFrame: Retrospective analysis of data between 2004 and 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT04818931: Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy
Official title: Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 326
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting and there is no guideline for their use for wire-localized lumpectomy. The aims of this study were to determine whether a single dose of pre-operative antibiotic reduces surgical site infection (SSI) for wire-localized lumpectomy and to identify risk factors for SSI.

Methods: This was a prospective randomized trial carried out from April 2018 to June 2019 at the "Centre des Maladies du Sein du CHU de Québec - Université Laval", a tertiary center specialized in breast surgery. After informed consent, patients who underwent wire-localized lumpectomy were randomized to receive or not a pre-operative single dose of prophylactic antibiotic (cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy). Data regarding demographics, comorbidities, perioperative details, and SSI were analyzed. SSI was considered if: 1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion) within 30 days after operation, in the absence of wound culture or in the presence of negative results. The patients and the investigator responsible for data collection were blind to grouping. All patients were called 30 days after surgery to be sure that they did not consult at another hospital for surgical wound infection.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* female
* scheduled for a wire-localized lumpectomy

Exclusion Criteria:

* pregnant or breastfeeding women
* incapacity to give informed consent
* preoperative breast infection
* patients known to be colonized with MRSA
* immunocompromised patients
* preoperative antibiotic prophylaxis needed for any concomitant condition.

Primary outcomes:
measure: Number of participants with surgical site infection in each group
timeFrame: within 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
Study officials:
References:
citation: Giguere GB, Poirier B, Provencher L, Boudreau D, Leblanc D, Poirier E, Hogue JC, Morin C, Desbiens C. Do Preoperative Prophylactic Antibiotics Reduce Surgical Site Infection Following Wire-Localized Lumpectomy? A Single-Blind Randomized Clinical Trial. Ann Surg Oncol. 2022 Apr;29(4):2202-2208. doi: 10.1245/s10434-021-11031-9. Epub 2021 Nov 25.
Clinical trial NCT04184531: Sensenbrenner Clinical Study
Official title: An Observational, Clinical Study to Collect the Medical Data in Order to Determine the Craniofacial Characteristics Through Phenotypic Analysis on Children With Sensenbrenner Treated/Followed at the Hôpital Femme Mère Enfant From 2005
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensenbrenner Syndrome
Keywords: Sensenbrenner Syndrome
phenotypic analysis
craniofacial characteristics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Sensenbrenner syndrome

Brief summary: Sensenbrenner syndrome, also known as cranioectodermal dysplasia (CED), is a rare autosomal-recessive disorder belonging to the ciliopathy group of diseases. It is characterized by a facial dysmorphism, abnormal bone development and ectodermal defects including dental anomalies. CED is a heterogeneous condition with significant phenotypic and molecular variability, whose spectrum may include cases of renal impairment, hepatic fibrosis, retinitis pigmentosa and/or brain anomalies. In many cases, patients develop chronic kidney disease (CKD) due to nephronophthisis between 2 and 6 years of age. The aim of this retrospective study is to better understand the characteristics of this syndrome and to find prognostic factors of CKD. We make the hypothesis that an early diagnosis of the syndrome would lead to a better global management of patients (quality of life, delayed onset of end-stage renal disease).


Eligibility criteria: Inclusion Criteria:

* Boys and girls.
* Aged 3 to 18 years old.
* Subjects with a Sensenbrenner's syndrome diagnosis and followed from 2005
* Parents/ legal guardian must provide non opposition prior to participation in the study

Exclusion Criteria:

* Patients whose parents / legal guardian have object to using the data usually collected for care

Primary outcomes:
measure: Evaluation of renal impairment of 4 patients with Sensenbrenner identified with WDR19 and WDR35 mutations, through measurement of level of creatinine in the urine.
timeFrame: The result of Creatinine in children with Sensenbrenner syndrome will be collected though study completion an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
Study officials:
References:
Clinical trial NCT00411931: A Pharmacokinetics Study of MultiHance in Pediatric Patients
Official title: A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Nervous System Pathology
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-12-15
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults


Eligibility criteria: Inclusion Criteria:

* Male or female between 2 and 5 years of age
* Obtained informed consent from patient's parent or guardian
* Obtain assent when applicable according to local law
* Known or suspected disease of the central nervous system (brain or spine)
* Referred for MRI of the brain or spine requiring an injection of an MR contrast agent

Exclusion Criteria:

* Contraindications to MR examination
* Undergoing MRI in an emergency situation
* Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
* Sickle cell anemia
* Likely to undergo an invasive examination within 72 hours after administration of the investigational product

Primary outcomes:
measure: Assess the blood PK of Multihance in patients from 2 to 5 years of age
timeFrame: up to 24 hours post dose
Secondary outcomes:
measure: Evaluate the safety of Multihance in patients from 2 to 5 years of age
timeFrame: through 72 hours post dose
Other outcomes:
Locations:
city: Krakow
country: Poland
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, M. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04166682: Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
Official title: A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).


Eligibility criteria: Inclusion Criteria:

* Aortic stenosis accepted for TAVR
* Participant able and willing to give written informed consent
* Participant able (in the investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria: subjects may not enter the study if any of the following apply

* Intervention deemed inappropriate due to co-morbidity or frailty
* Life expectancy less than one year due to co-morbidity
* Previous surgical aortic valve replacement (sAVR) or TAVR
* Predominant aortic regurgitation

Primary outcomes:
measure: 6-minute walk test
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants die
timeFrame: 6 weeks, 12 months
measure: Number of participants rehospitalized
timeFrame: 6 weeks, 12 months
measure: Number of participants completing home-based cardiac rehabilitation
timeFrame: 6 weeks
measure: Cardiac function
timeFrame: 12 months
measure: Aortic valve function
timeFrame: 12 months
measure: Number of participants injured
timeFrame: 6 weeks
measure: Time spent performing activities
timeFrame: 6 weeks, 12 months
measure: 6-minute walk test
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang university, school of medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xianbao Liu, Doctor
role: STUDY_CHAIR
References:
citation: Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Clinical trial NCT01538082: Role of the Stress in the Development of the Metabolic Syndrome
Official title: Role of Anxiety, Depression, Quality of Life and Stressful Vital Events in the Development of the Metabolic Syndrome. StreX Project.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety Disorders
Depressive Disorders
Metabolic Syndrome
Stress Disorders
Keywords: Anxiety disorders
Depressive disorders
Metabolic syndrome
Stress disorders
Primary care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Society of Family Medicine
name: Spanish Society of Family and Community Medicine
First posted: 2012-02-23
Enrollment: 738
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aleatory sample of subjects with high risk ( 1 or 2 criteria NCEP-ATPIII ) to develop Metabolic Syndrome, elderly than 40 years and attended in Primary Care in the last year. This sample will be provided by the Information's Technology in Primary Care Services.

Brief summary: The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people of high risk, of 40 or more years and attended in the Primary Care. Evaluating the association between anxiety, depression, quality of life and the vital stressful events, and the development of the metabolic syndrome in general population.

Our hypothesis is that population of the cohort with bigger degree of stress will develop earlier the metabolic syndrome.

If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing in a future interventions on these factors of risk to prevent or to decrease the incidence of this syndrome in the Primary Care.


Eligibility criteria: Inclusion Criteria:

* Both genders, elderly than 40 years
* Subjects with 1 or 2 criteria of NCEP-ATPIII set for Metabolic Syndrome

  * Abdominal waist \> 102 cm ( men ) or \>88 cm ( women )
  * Blood Pressure ( \>130/85 mmHg ) ( or else pharmacologic treatment of hypertension )
  * Hypertriglyceridaemia ( \>150 mg/dl ) ( or else pharmacologic treatment )
  * HDL-cholesterol \<40 mg/dl ( men ) or \<50 mg/dl ( women ) ( or else treatment )
  * Fasting glucose \> 110 mg/dl.

Exclusion Criteria:

* Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
* Severe or terminal disease
* Severe mental disease that difficulties the follow-up

Primary outcomes:
measure: Incidence of metabolic syndrome
timeFrame: One year
Secondary outcomes:
measure: Association between risk factors and metabolic syndrome
timeFrame: One year
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Catalan Health Institute. ABS Reus-4
state: Tarragona
Study officials:
affiliation: Catalan Institute of Health
name: Yolanda Ortega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Juan J Cabré, MD, PhD
role: STUDY_DIRECTOR
affiliation: Catalan Institute of Health
name: Josep L Piñol, MD, PhD
role: STUDY_CHAIR
References: