louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00300989: Inion OTPS Biodegradable Fixation System for the Ankle
Official title: A Double-Blind,Randomised,Prospective Clinical Investigation to Compare Post-Operative Fracture Healing Using the Inion OTPS Biodegradable Fixation System Versus Conventional Metal Screws and Plates in the Treatment of Ankle Fractures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgery
Lead sponsor: Inion Oy
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.


Eligibility criteria: Inclusion Criteria:

* Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured
* Fresh/acute fracture
* Aged between 18 and 60 years

Exclusion Criteria:

* Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed
* Multiple trauma
* Previous ankle fracture
* Pregnancy
* Bone malignancy
* Any clinically significant condition based on investigators judgement
* high-load bearing applications

Primary outcomes:
measure: Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 months post-operatively.
Secondary outcomes:
measure: Sequential post-operative radiographs at 12 months post-operatively; Timepoints for returning to work and/or sport; Wound healing; SF-36 Questionnaire; Subjective pain evaluation
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Inion Oy
Study officials:
affiliation: Aarhus University Hospital
name: Ole Brink
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku Universal Central Hospital
name: Terho Kainonen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Geir Stray Andreassen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492189: Containment Measures and Eating Disorders
Official title: Impact of Containment Measures in People With Eating Disorders: a Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorders
COVID 19
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: INSERM U1061 (Statistics)
First posted: 2020-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are adult women with a diagnostic of ED

Brief summary: Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.

In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.

Detailed description: Investigators will recruit 40 patients with eating disorders. All patients were initially assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department (Montpellier University Hospital) from January to march 2020.

All participants will performed a phone interview to assess eating disorder symptoms, caracteristicus of containment, 1 month after the beginning of the containment, and 1 month after the end of the containment.

Eligibility criteria: Inclusion criteria:

* Adult women
* Surferring from ED
* Assessed in the ED daily hospital (UH of Montpellier) from January to March 2020

Exclusion criteria:

* minors
* refusal to participate

Primary outcomes:
measure: Variation in eating disorders
timeFrame: 1 month
measure: Variation in eating disorders
timeFrame: 1 month
Secondary outcomes:
measure: Vision of the bodily aspect
timeFrame: 1 month
measure: Vision of the bodily aspect
timeFrame: 1 month
measure: Variation in physical activity
timeFrame: 1 month
measure: Variation in physical activity
timeFrame: 1 month
measure: Identify the clinical factors modulating the psychological state during confinement
timeFrame: 1 month
measure: Identify the clinical factors modulating the psychological state during confinement
timeFrame: 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Ariane SULTAN, PR
role: STUDY_DIRECTOR
References:
Clinical trial NCT03262389: Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
Official title: Comparison of F-18 FDG PET CT and PET MRI With C-11 Acetate PET CT and PET MRI in the Diagnosis of Active Multiple Myeloma Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: positron emission tomography (PET)
computerized tomography (CT)
Magnetic resonance imaging (MRI)
Fludeoxyglucose (F-18 FDG)
C-11 acetate
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Investigators are doing this study to determine which of four imaging techniques: Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18 FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is the best test for finding sites of active myeloma disease.

Detailed description: Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously, followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11 radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10 minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute pause with the participant at rest. At the end of 60 minute pause, the participant is given the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member makes a phone call to participant for follow up.

Eligibility criteria: Inclusion Criteria:

* Patients being staged for multiple myeloma as follows: new diagnosis, high risk smoldering multiple myeloma, relapsed as defined by investigator
* Patients who have undergone standard of care workup
* 300 pounds or less
* Can provide informed consent
* Scheduled for a clinically indicated F-18 FDG PET scan
* English speaking

Exclusion Criteria:

* Pregnant, breast feeding
* Concurrent active non-multiple myeloma malignancy
* Contraindication to PET MRI
* Previous Type I or Type II Diabetes mellitus or a fasting blood glucose \>150 mg/dl

Primary outcomes:
measure: Mean Multiple Myeloma Lesions Detected
timeFrame: Day 1, Day 2
Secondary outcomes:
measure: Visual Image Analysis of Detected Multiple Myeloma Lesions
timeFrame: Approximately one month after Day 2
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Michael C Roarke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04026789: Medication Abortion for Pregnancy of Unknown Location
Official title: Medication Abortion for Pregnancy of Unknown Location
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.


Eligibility criteria: Patients with an undesired pregnancy of less than or equal to 42 days gestation based on last menstrual period (LMP) who present to Planned Parenthood League of Massachusetts (PPLM)'s Greater Boston Health Center seeking medication abortion will be considered for study participation.

Inclusion criteria:

* Positive urine or serum hCG test
* No evidence of gestational sac on transvaginal ultrasound
* Desire for medication abortion as method of pregnancy termination

Exclusion criteria:

* Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
* Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
* High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
* Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
* LMP \> 42 days or unknown LMP
* Age less than 18 years
* Prior participation in this study
* Anticipated inability to present for scheduled follow-up visits

Primary outcomes:
measure: Time to completed abortion
timeFrame: through study completion, an average of two weeks
Secondary outcomes:
measure: Number of participants with complete expulsion of pregnancy without surgical intervention
timeFrame: 14 days after initiation of medical abortion
measure: Time to diagnosis of pregnancy outcome
timeFrame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
measure: Rate of ectopic pregnancy
timeFrame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
measure: Percent of participants who complete follow-up and confirm complete abortion
timeFrame: Within 1 month of identification of pregnancy of unknown location on ultrasound
Other outcomes:
Locations:
city: Boston
country: United States
facility: PPLM
state: Massachusetts
Study officials:
References:
Clinical trial NCT03612089: From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain
Official title: From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Chronic Low Back Pain
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2018-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leuven and surroudings

Brief summary: To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.


Eligibility criteria: Inclusion criteria for chronic low back pain group:

* Non-specific low back pain, during 3 or more months, without radicular leg pain
* Modified Low Back Pain Disability Questionnaire \> 20%
* Indication for MRI of the lumbar spine
* No contra-indications for MRI
* Informed consent to participate

Inclusion criteria for healthy control group:

* No history of low back pain needing medical treatment or resulting in limited activity level
* Any low back pain in the previous 3 months
* Informed consent to participate

Exclusion criteria for all subjects:

* Pregnancy
* Previous trauma or surgery to spine, abdomen or pelvis
* Structural deformity (e.g. scoliosis)
* Neurological/neuromuscular/systemic disease
* Inability to lie prone for 20 minutes

Primary outcomes:
measure: Lumbar multifidus muscle volume measured by 3DfUS
timeFrame: immediately after inclusion in the study
measure: Lumbar multifidus muscle volume measured by MRI
timeFrame: immediately after inclusion in the study
measure: Cross-sectional area of the lumbar multifidus
timeFrame: immediately after inclusion in the study
measure: Thickness of the lumbar multifidus
timeFrame: immediately after inclusion in the study
measure: Proprioceptive postural control strategies in patients with low back pain with healthy controls
timeFrame: immediately after inclusion in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT00935389: Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria
Official title: Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Nephritis
Proteinuria
CTX
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.

Detailed description: Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Eligibility criteria: Inclusion Criteria:

1. SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
2. Urine protein≥3.0g/24h, Alb\<30g/L and Scr\<1.5mg/dL.
3. All cases are type IV, confirmed by renal biopsy.
4. All patients sign the informed consent and be willing to follow-up on time

Exclusion Criteria:

1. Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
2. Scr level above 1.5mg/dL, lasts more than 3 months.
3. Heart, lung or central nervous systems involved or combined with severe infection.
4. With liver function abnormal, ALT or AST being two times above the normal.
5. Pregnant women or patients still in lactation.

Primary outcomes:
measure: To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Research Institute of Nephrology,Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Hu Weixin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04675489: Visual Outcomes After Vivity Toric IOL Implantation
Official title: Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractive Assessment
Keywords: Vivity
Extended Vision Toric Intraocular Lens
Patient satisfaction and visual outcomes
Lead sponsor: EVP Eye Care
Sponsor class: OTHER
Collaborators: name: Alcon Research
name: Icon Eye Care
First posted: 2020-12-19
Enrollment: 4
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.

Detailed description: To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.

Eligibility criteria: Inclusion Criteria:

* Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
* Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
* Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator

Exclusion Criteria:

* Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
* Ocular trauma or zonular weakness/instability
* Diagnosis of glaucoma or high-risk glaucoma suspect
* Previous refractive surgery
* Unreliable preoperative biometry measurements
* Severe dry eye or ocular surface disease

Primary outcomes:
measure: Monocular visual acuity at distance
timeFrame: 4 months
measure: Binocular visual acuity at distance
timeFrame: 4 months
measure: Monocular best corrected distance visual acuity
timeFrame: 4 months
measure: Binocular best corrected distance visual acuity
timeFrame: 4 months
measure: Monocular best distance-corrected intermediate visual acuity
timeFrame: 4 months
measure: Binocular best distance-corrected intermediate visual acuity
timeFrame: 4 months
measure: Monocular best distance-corrected near visual acuity
timeFrame: 4 months
measure: Binocular best distance-corrected near visual acuity
timeFrame: 4 months
Secondary outcomes:
measure: Residual refractive cylinder
timeFrame: 4 months
Other outcomes:
Locations:
city: Grand Junction
country: United States
facility: Icon Eye Care
state: Colorado
Study officials:
affiliation: Icon Eye Care
name: James Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978289: Microenvironment of Adipose Tissue in Endocannabinoid System
Official title: Microenvironment of Adipose Tissue in Endocannabinoid System Before and After Roux-en-y Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
gastric bypass surgery
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects approved and scheduled for gastric bypass surgery

Brief summary: The purpose of this study is examine the relationship between adipose tissue inflammation and activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery. The investigators hypothesize that the metabolic improvements and weight loss are due to mechanisms that antagonize the endocannabinoid system.


Eligibility criteria: Inclusion Criteria:

* BMI\>35 kg/m2
* Age 20-60 yrs
* Approved and scheduled for gastric bypass surgery
* Stable body weight for past 3 months

Exclusion Criteria:

* Positive pregnancy test
* Previous gastric surgeries
* Intercurrent infections
* History of ketoacidosis or current metabolic acidosis
* Serum creatinine or liver function tests \> 2 times upper limits of normal
* Taking drugs that are known to affect carbohydrate or lipid metabolism other than anti-diabetes mediations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447889: A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography
Official title: A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Occlusive Disease
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2007-03-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a clinical study of gadoteric acid in non-coronary MR angiography.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least the age of legal maturity
* Strongly suspected of having non-coronary arterial disease, detected clinically
* Scheduled to undergo x-ray angiography examination
* Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
* Females of childbearing potential must have a documented negative urine pregnancy test.

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
* Congenital morphologic vascular abnormalities
* Known allergy to gadolinium chelates
* Pregnant, breast feeding, or planning to become pregnant during the trial
* Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Guerbet
name: Corinne Dubourdieu, PhD
role: STUDY_CHAIR
References: