louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01023178: Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Official title: Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Failure, Premature
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.

Detailed description: Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.

Eligibility criteria: Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure

* Outpatients
* age \>=12 years to 17.99 years old

Exclusion Criteria:

* spontaneous menses
* significant concurrent medical problem including:
* Liver function tests (LFTs) 3 times normal
* clotting disorder
* ongoing cancer treatment

Primary outcomes:
measure: Estradiol
timeFrame: end of study (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Darrell M Wilson
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: E Kirk Neely
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Sejal Shah
role: SUB_INVESTIGATOR
References:
citation: Shah S, Forghani N, Durham E, Neely EK. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism. Int J Pediatr Endocrinol. 2014;2014(1):12. doi: 10.1186/1687-9856-2014-12. Epub 2014 Jun 20.
Clinical trial NCT02013778: Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC
Official title: Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: outside of transplant criteria
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.


Eligibility criteria: Inclusion Criteria:

* Patient capable of giving informed consent
* Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL.
* Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania.
* Age 18 years old
* Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5
* Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L
* Child-Turcotte-Pugh Classification A or B
* Eastern Clinical Oncology Group performance status 0 or1.

Exclusion Criteria:

* Prior TACE
* Active GI hemorrhage within 2 weeks of study enrollment
* Ascites refractory to medical therapy
* Contraindication to receiving HCQ or TACE
* Unilobar HCC
* Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging)
* Women who are pregnant
* Participation in another concurrent treatment protocol

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Gregory Nadolski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427878: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?
Official title: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19 Patients
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years old
* Patients testing positive for Covid19
* Patients affiliated to social security
* Signing of free and informed consent

Exclusion Criteria:

* Vulnerable persons (- minors,
* adults under guardianship or curatorship,
* pregnant women,
* persons deprived of their liberty,
* persons who do not master the French language)

Primary outcomes:
measure: The presence of SARS-CoV2 in adipose tissue of Covid19 patients
timeFrame: Day 0
Secondary outcomes:
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
timeFrame: Day 0
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
timeFrame: Day 0
measure: The expression of inflammatory cytokines in adipose tissue of Covid19 patients
timeFrame: Day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT02199678: A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
Official title: A Randomized,Double Blind, Parallel Group, Placebo Controlled Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Lotus Clinical Research, LLC
Sponsor class: OTHER
Collaborators: name: iX Biopharma Ltd.
First posted: 2014-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.


Eligibility criteria: 18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

Primary outcomes:
measure: Sum of Pain Intensity Difference
timeFrame: 3 hours
Secondary outcomes:
measure: Sum of Pain Intensity Difference
timeFrame: 6 hours
measure: Safety and tolerability
timeFrame: 6 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Salt Lake City
country: United States
facility: Prahealthsciences
state: Utah
Study officials:
References:
Clinical trial NCT03985878: A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
Official title: An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients With Duchenne Muscular Dystrophy Who Have Completed Study 4658-102
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy
Keywords: DMD
Duchenne
Eteplirsen
Dystrophy
Dystrophin
Exon Skipping
Exon 51
Ambulatory
Pediatric
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 15
Sex: MALE
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have successfully completed the 96-week eteplirsen Study 4658-102.


Eligibility criteria: Inclusion Criteria:

* Participant successfully completes 96 weeks of treatment in Study 4658-102.

Exclusion Criteria:

* Participant has a prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant, or make it unlikely that the course of treatment or follow-up would be completed, or impair the assessment of study results.

Other inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 162 weeks
measure: Number of Participants Experiencing Death Due to Adverse Events
timeFrame: Up to 162 weeks
measure: Number of Participants Experiencing Adverse Events of Special Interest (AESIs)
timeFrame: Up to 162 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ-Gent
city: Paris
country: France
facility: Hopital Trousseau, Bâtiment lemariey
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, UOC Neuropsichiatria Infantile
city: London
country: United Kingdom
facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre
state: England
Study officials:
affiliation: Sarepta Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04756778: Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy
Official title: Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Aneurysm
Bicuspid Cardiac Valve
Lead sponsor: St. George's Hospital, London
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 69
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: All consecutive adult patients undergoing first-time surgery for a BAV-related aneurysm involving the aortic root and/or ascending aorta, between 2010-2016 at our institution

Brief summary: This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* First-time surgery
* Bicuspid aortic valve confirmed
* Thoracic aortic aneurysm involving aortic root or ascending aorta

Exclusion Criteria:

* No available pre-operative cross-sectional imaging
* Re-do surgery

Primary outcomes:
measure: Median aortic diameters in aneurysms
timeFrame: Data collection period from 27th January 2017 - 15th May 2017
measure: Cross-sectional aortic area/patient height ratio in aneurysms
timeFrame: Data collection period from 27th January 2017 - 15th May 2017
measure: Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m
timeFrame: Data collection period from 27th January 2017 - 15th May 2017
measure: Median cross-sectional aortic area/patient height ratio for aneurysms with diameter <4.0 cm, 4.0-4.5 cm, 4.5-5.0 cm, 5.0-5.5 cm and >5.5 cm
timeFrame: Data collection period from 27th January 2017 - 15th May 2017
measure: Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m
timeFrame: Data collection period from 27th January 2017 - 15th May 2017
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. George's Hospital
state: Middlesex
Study officials:
References:
Clinical trial NCT00302978: Changes in Brain Activity (Functional MRI Study) Before and After Behavioral Therapy of Height Phobia
Official title: The Effects of in Vivo Exposure Therapy on the Neural Correlates of Height Phobia: a Functional Magnetic Resonance Imaging Study Using a Fear Provocation Paradigm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Height Phobia
Fear of Heights
Keywords: Height phobia
fear of heights
specific phobia
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are interested in investigating the functional brain abnormalities of height phobia. Subjects will be have a functional MRI scan before and after a course of treatment with behavioral therapy.

Detailed description: The purpose of this study is to investigate the effects of in vivo exposure therapy on the functional brain activity of subjects with height phobia using a fear provocation paradigm. We expect differential activation of the fear circuitry in height phobics compared to non-phobic controls, and that successful behavioral therapy will normalize the heightened fear response in height phobia.

Eligibility criteria: Inclusion Criteria:

* Specific phobia of Heights

Exclusion Criteria:

* History of medical problems

Primary outcomes:
measure: CGI
Secondary outcomes:
measure: acrophobia questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: New York State Psychiatric Institute, Columbia University
name: Yujuan Choy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00950378: Non-Invasive Management of Chronic Venous Insufficiency
Official title: Non-Invasive Management of Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Insufficiency
Keywords: edema
blood supply
lower legs
venous stasis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: PhiloMetron, Inc.
First posted: 2009-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CVI subjects will be recruited from University of Utah vascular surgery service.Control group will be recruited from the community.

Brief summary: The purpose of this study is:

-item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency.

The study hypothesis:

- item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.


Eligibility criteria: Inclusion Criteria:

* participants with CVI with CEAP class 4 or higher
* participants with no CVI class 0

Exclusion Criteria:

* open ulcers or lower extremity amputation
* diabetics with HbA1C greater than 7.0
* arterial occlusive disease
* BMI greater than 35
* any connective tissue disorder (lipodermatosclerosis and fibrosis)
* participants with metallic prosthesis or implants
* participants with renal impairment
* pregnancy
* inability or refusal to wear compression stockings prescribed by physician (CVI patients only)

Primary outcomes:
measure: To provide device development to assess tissue changes associated with chronic venous insufficiency
timeFrame: two years
Secondary outcomes:
measure: To compare device development to existing clinical measurement
timeFrame: two years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Harriet Hopf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
citation: Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. doi: 10.1177/1358836X9900400101.
Clinical trial NCT01501578: Pulmonary Fibrosis and Telomerase Mutation Study
Official title: Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Keywords: Pulmonary fibrosis
Telomerase mutation
Lead sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor class: OTHER
Collaborators: name: Bichat Hospital
First posted: 2011-12-29
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pulmonary fibrosis with and without telomerase mutation

Brief summary: This study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation.

The purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on CT scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

Detailed description: Two "control" subjects will be enrolled for one subject with telomerase mutation.

The data are all the results of investigations conducted for the diagnosis of idiopathic pulmonary fibrosis and during routine follow up of patients.

The CT scans will reviewed centrally to homogenize the description.

Eligibility criteria: Inclusion Criteria:

* Diffuse interstitial lung disease on CT scan
* Telomerase mutation analysis

Exclusion Criteria:

* Presence of connective tissue disease, or pneumoconiosis or drug induced lung disease

Primary outcomes:
measure: Description of imaging pattern
timeFrame: at baseline only
Secondary outcomes:
measure: Pathology of the lung
timeFrame: at baseline only
measure: Pulmonary function tests
timeFrame: from diagnosis to last follow-up, for an average of one year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Louis Pradel Hospital (Bâtiment A4)
Study officials:
affiliation: Hospices civils de Lyon / University Lyon I
name: vincent Cottin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01379378: Male Stress Urinary Incontinence and Sexual Health
Official title: Male Stress Urinary Incontinence and Sexual Health
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-prostatectomy patients at least 6 months after either open radical retropubic prostatectomy or robot assisted laparoscopic prostatectomy with bothersome stress urinary incontinence will be initially screened with urodynamics, a 24 hour pad test, and a self questionnaire to assess how bothersome their incontinence is.

Brief summary: The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.


Eligibility criteria: Inclusion Criteria:

* Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.

Exclusion Criteria:

* Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia.
* They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).

Primary outcomes:
measure: Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
timeFrame: 1 year
measure: Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Craig Vance Comiter
role: PRINCIPAL_INVESTIGATOR
References: