louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02752503: Nalmefene in Alcohol Dependence and Borderline Personality Disorder
Official title: Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Borderline Personality Disorder
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Hospital Universitari General de Catalunya
First posted: 2016-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.


Eligibility criteria: Inclusion Criteria:

* Alcohol use disorder according to DSM 5
* Borderline personality disorder according to DSM 5
* CGI-BPD \> 3
* Female have to use contraception

Exclusion Criteria:

* Other axis I disorders
* Severe organic disorder
* Pregnancy or breastfeeding
* Allergy to Nalmefene
* Subjects with Opioids use disorder or in treatment with opioid agonists

Primary outcomes:
measure: Days of excessive alcohol intake
timeFrame: 2 months
measure: Daily average intake (grams)
timeFrame: 2 months
Secondary outcomes:
measure: Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
timeFrame: 2 months
measure: Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)
timeFrame: 2 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Juan C Pascual, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353103: Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy
Official title: Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carotid Artery Stenosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Health care system affiliation
* Referred to carotid endarterectomy
* Symptomatic patients:

  * Carotid stenosis between 70 and 99% (NASCET criteria)
  * TIA or minor stroke attack (RANKIN ≤ 3)
* Asymptomatic patients:

  * Carotid stenosis between 70 and 99% (NASCET criteria)
  * No symptoms
* Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria:

* Contra indication to MRI
* Renal failure (clearance \< 30ml/mn)
* Patient with active inflammatory disease
* History of cancer
* Pregnancy or lactation
* Patient with carotid disease treated by fibrinolysis
* Patient under guardianship, or unable to understand the purpose of the study

Primary outcomes:
measure: carotid F18-NaF uptake
timeFrame: baseline
Secondary outcomes:
measure: comparaison of F18-NaF PET and Carotid MRI
timeFrame: baseline
measure: F18-NaF PET uptake
timeFrame: baseline
measure: histology
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT01927003: Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Official title: Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Finger Injuries
Soft Tissue Injuries
Keywords: defect,
dorsal branch of the digital artery,
dorsal digital flap,
dorsal metacarpal artery flap.
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2013-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. The authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.

Detailed description: At final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent \<6 mm, good 6-10 mm, fair 11-15 mm, poor \>15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and consider this normal. The measurements are performed at a single time point at final follow up.

Eligibility criteria: Inclusion Criteria:

* the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries
* a soft tissue defect \> 1.5 cm in length with exposed bone or tendon
* the reverse DMA flap may not be appropriate for tissue reconstruction due to the concomitant injuries or due to the limitation of the rotation arc
* a patient between 15 and 60 years of age

Exclusion Criteria:

* concomitant injuries involved all the finger that precluded their use as donor sites
* a defect less than 1.5 cm in length
* injuries to the course of the vascular pedicle

Primary outcomes:
measure: The Static 2-point discrimination test
timeFrame: 18 to 24months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 18 to 24 months
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Yang D, Morris SF. Reversed dorsal digital and metacarpal island flaps supplied by the dorsal cutaneous branches of the palmar digital artery. Ann Plast Surg. 2001 Apr;46(4):444-9. doi: 10.1097/00000637-200104000-00017.
citation: Chen C, Zhang W, Tang P. Direct and reversed dorsal digito-metacarpal flaps: a review of 24 cases. Injury. 2014 Apr;45(4):805-12. doi: 10.1016/j.injury.2013.11.002. Epub 2013 Nov 13.
Clinical trial NCT01023503: Observational Study To Evaluate Statins Patterns Of Use In Spain
Official title: Statins Use Patterns in Spain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dyslipidemia
Keywords: Statins
Dyslipidemia
Spain
Rosuvastatin
Naive
Switching
New statins prescriptions in Spain (naive patients and switching)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Fundació Institut Català de Farmacologia
First posted: 2009-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To be recruited by Primary Care Physicians

Brief summary: The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.


Eligibility criteria: Inclusion Criteria:

* Patients receiving a new statin prescription (naïve patients)
* Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)

Exclusion Criteria:

* Patients without enough information in the medical records to complete the fields required in the eCRF

Primary outcomes:
measure: Current and previous hypolipemic treatment, dose and pattern
timeFrame: Retrospectively (information for the previous 6-months). Information collected once.
measure: Statin treatment start date, origin of the prescription, reasons for changes in prescription
timeFrame: Retrospectively (information for the previous 6-months). Information collected once.
Secondary outcomes:
measure: Socio-demographic characteristics
timeFrame: retrospectively
measure: Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels
timeFrame: retrospectively
measure: Concomitant Treatments and Cardiovascular History
timeFrame: retrospectively
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Research Site
Study officials:
References:
Clinical trial NCT01373203: The Role of Fibrocytes in Acute Lung Injury
Official title: The Role of Fibrocytes in Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury(ALI)
Keywords: Acute Lung Injury(ALI)
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 20
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Lung Injury patients

Brief summary: The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF expression. Therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. The central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall objective of this project is to study the role of fibrocytes in acute lung injury.


Eligibility criteria: Inclusion Criteria:

* Acute Lung Injury patients
* Above 20 years old
* Bilateral lung infiltrates
* PaO2/FiO2\<300mmHg
* PCWP\<18mmHg

Exclusion Criteria:

* Pregnant women
* Under 20 years old
* Hb\<8.0mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Kuan-Jen Bai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522703: Effects of Whole Sprouts on Airway Allergic Inflammation
Official title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Asthma
Allergy
Keywords: asthma
allergic rhinitis
dietary interventions
mouse allergy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2012-02-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.

The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.


Eligibility criteria: Inclusion Criteria:

* doctor diagnosis of asthma
* aeroallergen sensitization
* Non-smoker
* Negative pregnancy test
* Not breastfeeding
* Normal TSH
* For women, abstinent or using reliable birth control
* Age 18-50 years
* No other major pulmonary disease such as cystic fibrosis or COPD
* Willingness to participate in study and sign consent form

Exclusion Criteria:

* Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
* Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
* Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
* Pregnancy or nursing/breastfeeding mothers
* On beta-blocker therapy
* On reserpine, clonidine, imipramine, or related tricyclic drugs
* Taking anti-oxidant supplements
* Planned dietary changes during the study period
* Unable to stop antihistamines prior to skin testing
* Food allergy to Broccoli Sprouts or Alfalfa Sprouts
* Omalizumab use within the last 12 months
* Nasal polyps

Primary outcomes:
measure: Exhaled Nitric Oxide Concentrations
timeFrame: at 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elizabeth Matsui, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385903: Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ischemic Wound of the Lower Limb
Necrotic Arterial Wounds
Keywords: Flammacerium
Ischemic wound
Lower limb
Arteriopathy
Amputation
Dressing
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Rangueil Hospital
name: University Hospital, Caen
name: Beziers Hospital
First posted: 2015-03-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.


Eligibility criteria: Inclusion Criteria:

* Ischemic wound of the lower limb
* Minimum 50% necrosis
* Arteriopathy with ABI\<0.7 or \>1.3 with radiographic examinations
* No revascularisation procedure possible for any reasons
* No urgent amputation need
* Amputation considered in a short term
* Non life-threatened patients

Exclusion Criteria:

* Sulphonamide hypersensibility
* Propyleneglycols hypersensibility
* Enzyme glucose deshydrogenase deficiencies
* Others studies participation
* Tutorship or curatoship

Primary outcomes:
measure: Amputation rate
timeFrame: 6 months
Secondary outcomes:
measure: Infection rate
timeFrame: 6 months
measure: Wound size
timeFrame: 6 months
measure: Pain during dressing (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Wound healing Department
Study officials:
References:
Clinical trial NCT00905203: Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women
Official title: Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Diabetes
Keywords: Postmenopausal women
Diabetes
Skin microcirculation
Exercise capacity
Skeletal muscle oxygenation
Dose-response relationship
postmenopausal diabetic women
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is specifically to investigate (1) the exercising muscle oxygenation response in diabetic postmenopausal women; (2) the dose-response of different physical activity interventions on skeletal muscle oxygenation response; (3) the related mechanisms of training effects.


Eligibility criteria: Inclusion Criteria:

* Sedentary postmenopausal women
* Ages 45 to 70 years old

Exclusion Criteria:

* Known cardio-respiratory disease
* Diabetic complication
* Excessive weight change during last year
* Cancer and mental disorders

Primary outcomes:
measure: skeletal muscle oxygenation response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164943: Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
Official title: Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aneuploidy Rate
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.


Eligibility criteria: Inclusion Criteria:

* Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria:

* Male factor
* Uterine malformations
* genetic alterations

Primary outcomes:
measure: Aneuploidy Rate
timeFrame: 2011 January
Secondary outcomes:
measure: Oocyte morphology
timeFrame: 2011 january
measure: Outcome rates (implantation, pregnancy and miscarriage rate)
timeFrame: 2011 April
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Insituto Valenciano de Infertilida, Spain, Madrid
Study officials:
References:
Clinical trial NCT03322943: The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
Official title: The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cholangitis
Keywords: Ursodeoxycholic Acid
Response
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with primary biliary cholangitis and treated with Ursodeoxycholic Acid at West China Hospital by review of medical records.

Brief summary: This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year

Exclusion Criteria:

Autoimmune hepatitis Primary sclerosing cholangitis

Primary outcomes:
measure: Description of demographics, clinical index after treatment
timeFrame: up to 1 year
Secondary outcomes:
measure: Evaluation whether the PBC patients have response after treatment
timeFrame: within 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Li Yang, MD
role: STUDY_CHAIR
References: