louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004345: Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Usher Syndrome
Retinitis Pigmentosa
Keywords: Usher syndrome
ophthalmologic disorders
rare disease
retinitis pigmentosa
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 1999-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Examine the concentration of docosahexanoic acid (DHA) and other n-3 fatty acids in plasma, erythrocyte, and adipose tissue in patients with various forms of retinitis pigmentosa and Usher syndrome.

II. Determine the synthesis and catabolism of DHA from linolenic acid in these patients.

III. Determine the synthesis, absorption, and catabolism of DHA under different dietary conditions in these patients.

Detailed description: PROTOCOL OUTLINE: Patients may participate in one or more of the arms of this study.

Arm I (adipose tissue study): Adipose tissue is collected from the buttocks of patients with Usher II retinitis pigmentosa (RP), patients with non-Usher RP, and control subjects. Dietary histories are obtained from all patients and subjects.

Arm II (isotope study): Patients meeting the same criteria as in arm I receive oral D5-labeled linolenic acid and oral D4-labeled linolenic acid that is dissolved in oil and incorporated into foods. Subjects must avoid eating fish and shellfish during the 35 days of the isotope study. Blood samples are collected at 0, 8, 24, and 48 hours, daily on days 3-7, and then on days 10, 18, and 35.

Arm III (flaxseed oil feeding): Patients with all types of RP and control subjects receive flaxseed oil, a form of linolenic acid, for 12 weeks. Subjects may also receive high oleic safflower oil or olive oil as a control fat for 12 weeks. Subjects complete a diet history at the end of each fatty acid supplementation period. All subjects must follow a diet free of seafood and fish oil supplements.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Retinitis pigmentosa, including: Usher syndrome (types I and II) Simplex
* The following inheritance patterns eligible: X-linked recessive; Autosomal dominant; Autosomal recessive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: William Connor
role: STUDY_CHAIR
References:
citation: Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.
Clinical trial NCT00529945: PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness
Official title: The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: PFO
Stroke
Transient Ischemic Attack
Migraine
Decompression Illness
Keywords: PFO
Stroke
Transient Ischemic Attack
Migraine
Decompression Illness
Lead sponsor: Cierra
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years old
* PFO with one or more of:

  * Cryptogenic stroke,
  * TIA or embolism,
  * History of severe migraine headaches, or
  * History of severe decompression illness.

Exclusion Criteria:

* In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Primary outcomes:
measure: PFO closure at 6 months post procedure.
timeFrame: 6 months post procedure
Secondary outcomes:
measure: PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
timeFrame: 30 days; 6 and 12 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt Sankt katharinen
Study officials:
affiliation: Cardiovascular Center Frankfurt, Germany
name: Horst Sievert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01898845: A Phase I Study of LEE011 in Asian Patients
Official title: A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Neoplasms
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 17
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 evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.

Detailed description: This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.

Eligibility criteria: Inclusion Criteria:

* Patient with a histologically confirmed diagnosis of a solid tumor
* ECOG PS \<2
* Good organ function at screening visit
* A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy

Exclusion Criteria:

* Impairment of GI function
* Patients with concurrent severe and/or uncontrolled concurrent medical conditions
* Known diagnosis of HIV or active viral hepatitis
* Pregnant or nursing (lactating) women

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: First cycle (28 days)
measure: Maximum tolerated dose (MTD) and/or recomended dose (RD)
timeFrame: First cycle (28 days)
Secondary outcomes:
measure: Safety and Tolerability of LEE011
timeFrame: from informed consent till 28 days after end of treatment
measure: PK parameters of LEE011
timeFrame: every week up to first 4 weeks, once a week in the subsequent 2 weeks
measure: Best overall response
timeFrame: every 2 months until 28 days after end of treatment
measure: Overall response rate
timeFrame: every 2 months until 28 days after end of treatment
measure: Progression-free survival
timeFrame: every 2 months until 28 days after end of treatment
measure: Disease control rate
timeFrame: every 2 months until 28 days after end of treatment
measure: Duration of response
timeFrame: every 2 months until 28 days after end of treatment
measure: Overall response
timeFrame: every 2 months until 28 days after end of treatment
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Doi T, Hewes B, Kakizume T, Tajima T, Ishikawa N, Yamada Y. Phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Cancer Sci. 2018 Jan;109(1):193-198. doi: 10.1111/cas.13428. Epub 2017 Nov 12.
Clinical trial NCT03699345: CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
Official title: Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: CENTERA
THV
Transcatheter Heart Valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Brief summary: This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Detailed description: A prospective, international, single arm, multi-center post market clinical follow-up study.

Eligibility criteria: Inclusion Criteria:

* Severe native valve calcific aortic stenosis
* Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

Exclusion Criteria:

* Known hypersensitivity to Nitinol (nickel or titanium)
* Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
* Inability to tolerate anticoagulation/antiplatelet therapy

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Toulouse Cedex 3
country: France
facility: Clinique Pasteur Toulouse
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen (DHM)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital - Barcelona
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospital
state: East Sussex
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital Belfast
city: Birmingham
country: United Kingdom
facility: Queen Elisabeth Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: UKE Hamburg-Eppendorf - University Heart Center
name: Prof. Hermann Reichenspurner
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital, Klinik für Kardiologie
name: Prof.Dr. Stephan Windecker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03860545: New Markers of Cardiac Surgery Related Acute Kidney Injury.
Official title: The New Biochemical Markers of Cardiac Surgery Related Acute Kidney Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Cardiac Disease
Keywords: Acute Kidney Injury, cardiopulmonary bypass
brush-border enzymes of the proximal renal tubules
ischemia modified albumin
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 88
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: The study population will be divided into 2 groups regarding postoperative acute kidney injury

Brief summary: Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.

Detailed description: Cardiac surgery related acute kidney injury (CS-AKI) is an important clinical problem. Kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. The pathomechanisms of acute kidney injury (AKI) is complex and multifactorial. It may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. Biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. There has been no official recommendations toward routine use of analysed biomarkers.

Eligibility criteria: Inclusion Criteria:

* a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria:

* emergency operations or re-operations;
* a known pathology of the urinary tract or renal failure;
* chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppression, or steroids in the preoperative period;
* polycythemia, porphyria or pathological hemoglobin species in anamnesis;
* preoperative signs of hepatic failure;
* active autoimmune or neoplastic diseases, active infection;
* anticipated significant bleeding (anti-platelet agents), suggesting the use of blood-derived products during the operation and afterward
* acute myocardial infarction after operation

Primary outcomes:
measure: acute kidney injure after operation
timeFrame: up to 48 hours post operation
measure: acute kidney injure after operation
timeFrame: up to 48 hours post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
Study officials:
References:
Clinical trial NCT00076245: Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Official title: Cognitive Behavioral Approaches to Seasonal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Affective Disorder
Depression
Keywords: Phototherapy
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-01-19
Enrollment: 61
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 will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."

Detailed description: SAD is a condition in which people experience depression as a result of seasonal variations in sunlight. Although light therapy is a common treatment for SAD, a large proportion of people with SAD are resistant to this treatment. CBT is effective for nonseasonal depressive disorders, but its use for SAD has not been thoroughly explored. This study will determine whether CBT, alone and combined with light therapy, is as effective as light therapy alone in reducing SAD symptoms.

Participants in this study will be randomly assigned to light therapy, CBT, a combination of light therapy and CBT, or a control group (no therapy) for 6 weeks. CBT will be conducted twice a week; light therapy will be conducted twice a day. Assessments will be made before, during, and after the study treatment. Depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. A 6-month and 1-year follow-up visit will also be conducted. During the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of seasonal affective disorder (SAD)
* Willing and able to participate in the study procedures

Exclusion Criteria:

* Major psychological diagnoses other than SAD
* Current psychological or psychiatric treatment

Primary outcomes:
measure: Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version
timeFrame: Post-treatment
measure: Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
timeFrame: Post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences (USUHS)
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences (USUHS)
name: Kelly J. Rohan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791045: Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation
Official title: Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation Study in Endoscopic Thoracic Sympathetic Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Time
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.


Eligibility criteria: Inclusion Criteria:

* 135 patients underwent bilateral ETSB procedure under general anesthesia

Exclusion Criteria:

* patients who underwent one sided ETSB
* patients under the age of 18
* Patients over 65 years of age

Primary outcomes:
measure: anesthesia time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ilke Kupeli
Study officials:
References:
citation: Hashmonai M, Kopelman D. History of sympathetic surgery. Clin Auton Res. 2003 Dec;13 Suppl 1:I6-9. doi: 10.1007/s10286-003-1103-5.
citation: Caso R, Kelly CH, Marshall MB. Single lumen endotracheal intubation with carbon dioxide insufflation for lung isolation in thoracic surgery. Surg Endosc. 2019 Oct;33(10):3287-3290. doi: 10.1007/s00464-018-06614-9. Epub 2018 Dec 3.
Clinical trial NCT01229345: Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition
Official title: The Interactive Effect of Breakfast Consumption and Exercise on Metabolism, Appetite and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Balance,
Appetite,
Cognitive Function.
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18-45 years
* BMI 18.5-24.9 kg/m2
* Physically active: able to run for 1 h at a moderate pace
* Healthy

Exclusion Criteria:

* Smokers
* Food allergies
* Metabolic disorders
* Restrained eaters (equivalent of \>7 for restrained on TFEQ)
* Consuming herbal/dietary supplements
* History of head trauma
* Learning difficulties
* ADHD
* Dyslexia
* History of migraines
* Gastric problems

Primary outcomes:
measure: Energy balance
timeFrame: 24 h
Secondary outcomes:
measure: Blood glucose
timeFrame: 1.5 h area under the curve, post-consumption of a liquid snack
measure: Serum insulin
timeFrame: 1.5 h area under the curve, post-consumption of a liquid snack
measure: Subjective appetite ratings
timeFrame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
measure: Cognitive function measurements
timeFrame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
measure: Mood
timeFrame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
measure: Energy expenditure
timeFrame: 1.5 h mean following a liquid snack
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Centre, Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Emma J Stevenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04489745: Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2020-07-28
Enrollment: 72
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
* High-risk or unfavorable intermediate-risk as defined below:

High-risk localized prostate cancer, as defined by any one of the following factors:

Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher.

Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors:

Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and \>50% biopsy cores positive, or The presence of any two of the following: PSA\>10, cT2b-c, Gleason score 3+4 in any core

* No pelvic nodal metastases (based on CT or MRI findings)
* No distant metastases, based upon:

CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis

* Age ≥ 18
* KPS ≥ 70 (or ECOG 0-2)
* Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

* Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option)
* Patients with any evidence of distant metastases
* Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration
* Prior cryosurgery, HIFU or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohn's Disease or Ulcerative Colitis

Primary outcomes:
measure: progression free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: