louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06306274: Topical Tacrolimus for Breast Cancer-related Lymphedema
Official title: Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Lymphedema
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:

* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* BCRL ISL stage I or II
* Pitting edema
* Postmenopausal or use of Contraceptive drugs
* Healthy opposite arm
* L-Dex score over 10

Exclusion Criteria:

* Pregnant, breast-feeding, or aiming to conceive within the next year
* Bilateral breast cancer
* Contralateral lymphadenectomy
* Allergy to tacrolimus, macrolides, or iodine
* Pacemaker
* Known kidney or liver disease

Primary outcomes:
measure: Lymphedema volume
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Vejle
country: Denmark
facility: Lillebaelt Hospital
Study officials:
References:
Clinical trial NCT00718874: A Specialized Diet for the Unique Metabolic Characteristics of Peripubertal African American Girls
Official title: Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: obesity, puberty, diabetes,insulin dynamics
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2008-07-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)


Eligibility criteria: Inclusion Criteria:

* African American girls aged 9-14,
* Overweight \< 90th percentile

Exclusion Criteria:

* On medications known to affect metabolism prior disease diagnosis

Primary outcomes:
measure: decreased insulin secretion
timeFrame: 25 weeks
Secondary outcomes:
measure: decreased markers of inflammation; decreased estradiol concentration
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Krista Casazza, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498874: Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne
Acne Vulgaris
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 127
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe acne vulgaris
* Acne vulgaris unresponsive to oral antibiotics
* Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study

Exclusion Criteria:

* Use of medications or treatments from specified pre-treatment time periods through the end of the study
* Beard, moustache, sideburns or other facial hair that may interfere with evaluation
* Other forms of acne
* History of malignancy within 5 years
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of tuberculosis
* History of chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The mean absolute change from baseline in inflammatory facial lesion count at Day 84
timeFrame: Baseline and Day 84
Secondary outcomes:
measure: The proportion of subjects with a successful treatment outcome at Day 84
timeFrame: Baseline and Day 84
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Bay City
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: South Euclid
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01124474: Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Spine Surgery
Official title: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Procedures, Operative
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 5
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: This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with a shorter hospital stay after surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for major spine surgery at LLUMC University Hospital will be eligible for participation in this study

Exclusion Criteria:

* age under 18yr,
* coagulopathy, significant renal or hepatic dysfunction (creatinine or liver enzymes \> 50% above normal values),
* congestive heart failure,
* cardiac arrhythmias producing irregular rhythms, and patient refusal.

Primary outcomes:
measure: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
timeFrame: From end of surgey to approximately 1 week
Secondary outcomes:
measure: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
timeFrame: from the end of surgery to approximately 1 month
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Richard L Applegate, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808574: Screening for Obstructive Sleep Apnea Among Members of an Internet Weight Loss Community
Official title: Effect of a Web-Based Presentation on Communication With Healthcare Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Internet
Screening
Health belief model
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate effect size for planning of future studies, and (3) test the hypothesis that the intervention, compared to a control condition, would lead more individuals to discuss OSA with their healthcare provider.


Eligibility criteria: Inclusion Criteria:

* Member of SparkPeople.com community and logged on within previous month
* Live in the US

Exclusion Criteria:

* Prior diagnosis of OSA
* Prior discussions with healthcare provider about OSA

Primary outcomes:
measure: Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study
timeFrame: 12 weeks
Secondary outcomes:
measure: Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already
timeFrame: 12 weeks
measure: Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School, Houston
state: Texas
Study officials:
affiliation: University of Texas Medical School, Houston
name: Kevin O Hwang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620074: Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)
Official title: Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis Who Are Intolerant of Polyene Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aspergillosis
Keywords: invasive aspergillosis, opportunistic mold infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

Detailed description: The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Eligibility criteria: Inclusion Criteria:

Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

Exclusion Criteria:

Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.

Primary outcomes:
measure: Summary of Global Response at End of Treatment (EOT)
timeFrame: End of Treatment (Day 42)
Secondary outcomes:
measure: Summary of Global Response at Week 2, Week 4, and Week 6
timeFrame: Week 2, Week 4, Week 6
measure: Summary of Mortality
timeFrame: Up to Week 6
measure: Galactomannan Titer Assay Levels and Global Response
timeFrame: Up to Week 6
measure: Voriconazole Trough Levels With Intravenous and Oral Dosing
timeFrame: Week 1 through Week 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00271674: YAG Laser Versus Punch Biopsy for the Treatment of Tattoo Skin Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tattoo Skin Markers
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-01-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare patient satisfaction, clinical efficacy and adverse effects of Q-switched YAG laser versus punch biopsies for the treatment of tattoo dots that are applied as skin markers in relation to X-ray treatment of malignant disorders.


Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* Skin types I-IV,
* No previous laser treatment for the condition.

Exclusion Criteria:

* Younger than 18 years,
* Skin types V-VI,
* Pregnant or lactating women,
* Previous laser treatment for the condition,
* Recent exposure to sun or sun-beds,
* Treatment with oral retinoids within 3 months,
* Tendency to produce hypertrophic scars or keloids,
* Immunosuppressive treatment or disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD, PhD, DrMedSci.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224574: To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events
Official title: Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fribrillation, cardiovascular events, aging, D-dimer
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-10-20
Enrollment: 425
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: Patients with atrial fibrillation encountered in usual care

Brief summary: The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

Detailed description: Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.

Eligibility criteria: Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* follow-up not possible, poor prognosis within 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AP HP
Study officials:
affiliation: Hopital Lariboisière
name: Isabelle Mahé, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahe I, Drouet L, Simoneau G, Minh-Muzeaux S, Caulin C, Bergmann JF. D-dimer can predict survival in patients with chronic atrial fibrillation. Blood Coagul Fibrinolysis. 2004 Jul;15(5):413-7. doi: 10.1097/01.mbc.0000114440.81125.bd.
citation: Mahe I, Drouet L, Chassany O, Mazoyer E, Simoneau G, Knellwolf AL, Caulin C, Bergmann JF. D-dimer: a characteristic of the coagulation state of each patient with chronic atrial fibrillation. Thromb Res. 2002 Jul 15;107(1-2):1-6. doi: 10.1016/s0049-3848(02)00184-6.
citation: Mahe I, Grenard AS, Joyeux N, Caulin C, Bergmann JF. Management of oral anticoagulant in clinical practice: a retrospective study of 187 patients. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1339-42. doi: 10.1093/gerona/59.12.1339.
citation: Lafuente-Lafuente C, Mahe I, Extramiana F. Management of atrial fibrillation. BMJ. 2009 Dec 23;339:b5216. doi: 10.1136/bmj.b5216. No abstract available.
Clinical trial NCT02856074: Functional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used
Official title: Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The current management of ischemic stroke is based on different strategies that may be combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal, it seems necessary to evaluate practices in local care in the field and the impact of these on the prognosis of ischemic stroke victims. The aim of this observational study is to compare these different care practices without interfering with the choice of strategy.

A blood sample will also be taken at different times to study the value of growth differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as prognostic biomarkers


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic ischemic stroke defined according to WHO criteria and treated by intravenous thrombolysis at the stroke ICU at Dijon CHU, intravenous thrombolysis by telemedicine with subsequent transfer to the Dijon stroke ICU, and/or endovascular thrombectomy at Dijon CHU)
* Patients aged over 18 years.
* Patients who have provided written informed consent to take part in the study.

Exclusion Criteria:

* Patients who refuse to take part in the study.
* Subjects in custody.
* Patients (or a person of trust) who cannot be contacted by telephone during the follow-up.

Primary outcomes:
measure: Rate of handicap
timeFrame: 6 months
Secondary outcomes:
measure: Serum levels of biomarkers of stress
timeFrame: Changes compared with baseline levels at Day 1, Day 3, Day 7
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01779674: Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with atrial fibrillation

Brief summary: This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.


Eligibility criteria: Inclusion Criteria:

* patients with atrial fibrillation and planned cardioversion
* male and female patients aged at least 18 years
* patients being able to understand and to follow the study staff´s instructions
* signed informed consent

Exclusion Criteria:

* persons being hosted in an institution by administrative order or court injunction
* pregnancy or breast feeding
* persons not being able to consent
* persons with implanted electronic devices
* material incompatiblity
* acute or chronic inflammation of the external or middle ear canal
* abnormal anatomic ear canal (congenital or pathological)
* persons in a dependent relationship to the investigator or employment contract

Primary outcomes:
measure: scientific data
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Univeristy Hospital Aachen
state: North Rhine Westfalia
Study officials:
References:
citation: Zink MD, Bruser C, Winnersbach P, Napp A, Leonhardt S, Marx N, Schauerte P, Mischke K. Heartbeat Cycle Length Detection by a Ballistocardiographic Sensor in Atrial Fibrillation and Sinus Rhythm. Biomed Res Int. 2015;2015:840356. doi: 10.1155/2015/840356. Epub 2015 Jul 1.