louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00247663: Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Official title: Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Women With Advanced Breast Cancer
Keywords: Aromatase inhibitor
letrozole
breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2005-11-02
Enrollment: 17
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: - To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.


Eligibility criteria: Inclusion Criteria:

- Patients which participated in double blind study

Exclusion Criteria:

* Patients with intolerable toxicity.
* Patients which confirmed progressive disease during double blind study.
* Patients which have received concurrent anti-cancer therapy during double blind study.

Primary outcomes:
measure: Safety during treatment
Secondary outcomes:
measure: No secondary outcomes/objectives planned
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Amagasaki
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Cyuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Nigata
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04280263: Caffeine Study for Pain Control Following Total Joint Replacement
Official title: A Prospective Double Blinded Randomized Placebo Controlled Study of the Efficacy of Caffeine as an Analgesic Adjuvant for Acute Perioperative Pain Management Following Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 70
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: A prospective, double blinded, single center, randomized controlled study to evaluate the efficacy of caffeine in combination with acetyl salicylic acid (ASA) in the management of postoperative pain in patients undergoing total joint arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years old at the time of the surgery.
* Patient is treated by Rothman Orthopaedics institute and is scheduled for the surgical procedure at AtlantiCare Regional Medical Center.
* Patient is undergoing total hip or total knee arthroplasty.
* Patient has the diagnosis of Osteoarthritis of the hip or the knee, or other noninflammatory disease that results in joint damage to the hip or the knee.

Exclusion Criteria:

* Patient has known history of opioid addiction and/or has taken opioids preoperatively.
* Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
* Patient has a known allergy to aspirin or caffeine.
* Patient has history of chronic pain that required the intervention of a pain management doctor.
* Patient has an active infection at the time of surgery (systemic or localized) or history of chronic infections that affected the lower extremities.
* Patient has history of cancer that would affect patient reported outcomes including pain.
* Patient has history of neuropathic pain or nerve degenerative disease.
* Patients undergoing revision surgery would be excluded.
* Patients who require alternate DTV prophylaxis other than ASA.

Primary outcomes:
measure: post-operative pain
timeFrame: 2 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Orthopaedics at Egg Harbor Township
state: New Jersey
Study officials:
References:
Clinical trial NCT04750863: Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up
Official title: Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Onset Still Disease
Keywords: adult onset still disease
differential diagnosis
diagnosis performance
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 312
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: Adult patients with suspected adult onset still disease with at least 18 months of follow-up.

Brief summary: Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Detailed description: Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Eligibility criteria: Inclusion Criteria:

* adults
* with glycosylated ferritin dosage for suspected adult onset still disease
* with at least 18 month of follow-up

Exclusion Criteria:

* known infectious disease
* known cancer
* known active connective tissue disease or vasculitis

Primary outcomes:
measure: diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up
timeFrame: after 18 months of follow-up
Secondary outcomes:
measure: description of differential diagnosis mimicking adult onset still disease
timeFrame: after 18 months of follow-up
measure: identifying factors associated with the occurence of a differential diagnosis during follow-up
timeFrame: after 18 months of follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01870063: Comparision of FIBTEM and Blood-loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sternotomy
Bleeding Test
Keywords: 5 minute bleeding test
swamb
fibtem
extem
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 71
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: PROBABILITY_SAMPLE
Study population: Patient with full sternotomy

Brief summary: Correlation between FIBTEM and intraoperative blood loss


Eligibility criteria: Inclusion Criteria:

full sternotomy age \>18 Inform consent signed

Exclusion Criteria:

Hypofibrinogen

Primary outcomes:
measure: bleeding
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital
state: Hessen
Study officials:
References:
Clinical trial NCT01595763: Diagnostic Approach of Deep Vein Thrombosis in Primary Care
Official title: Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis
Keywords: Deep vein thrombosis
Primary care
Diagnosis
Clinical model
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 20
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 referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau

Brief summary: To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.

Detailed description: The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.

Eligibility criteria: Inclusion Criteria:

* Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau

Exclusion Criteria:

* anticoagulant treatment
* patients who will not be able to follow control visit
* patients with oncologic treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT01486563: Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
Official title: Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Detailed description: Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine.

The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Males
* Indication for radical prostatectomy

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min

Primary outcomes:
measure: u-NGAL
timeFrame: 2-4 hours
Secondary outcomes:
measure: u-Kim 1, u- FABP
timeFrame: 2-4 hours
measure: FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
timeFrame: 2-4 hours
measure: PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
timeFrame: 2-4 hours
measure: SBP, DBP, heartrate
timeFrame: 2-4 hours
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Study officials:
affiliation: Holstebro Regional Hospital
name: Anne Sophie P. Kancir, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kancir ASP, Johansen JK, Ekeloef NP, Pedersen EB. The effect of 6% hydroxyethyl starch 130/0.4 on renal function, arterial blood pressure, and vasoactive hormones during radical prostatectomy: a randomized controlled trial. Anesth Analg. 2015 Mar;120(3):608-618. doi: 10.1213/ANE.0000000000000596.
Clinical trial NCT00233363: Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Official title: An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Xerostomia
Sjogren's Syndrome
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
2. Patients aged 20 years or older at time of consent
3. Patients with dry mouth
4. Patients with decreased salivation

Exclusion Criteria:

1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
3. Patients who have received rebamipide within 3 months prior to obtaining informed consent
4. Patients who are pregnant, possibly pregnant, or lactating
5. Patients with a history of hypersensitivity to rebamipide
6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Primary outcomes:
measure: Overall Improvement Rate in Dry Mouth Symptoms
timeFrame: Weeks 2, 4, and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT00378963: Instrument Applied and Manual Manipulation Induced EMG Response in Asymptomatic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: EMG Response
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-09-21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the affects of instrumental and manual manipulation on the EMG response of asymptomatic subjects.


Eligibility criteria: Inclusion Criteria:

Asymptomatic subjects (without somatosensory peripheral pain) will be recruited in the study. Subjects must sign an informed consent.

Exclusion Criteria:

Subjects with heart failure and any nervous system diseases will be excluded from the study. Additional exclusions include osteoporosis, diabetes, pregnancy, vascular insufficiency, and history of joint replacement therapy. Subjects under medical treatment, surgery and trauma within six months will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: John Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung PS, Kang YM, Pickar JG. Effect of spinal manipulation duration on low threshold mechanoreceptors in lumbar paraspinal muscles: a preliminary report. Spine (Phila Pa 1976). 2005 Jan 1;30(1):115-22. doi: 10.1097/01.brs.0000147800.88242.48.
Clinical trial NCT00524563: Clinical Outcomes and Global Epidemiology -Data Coordinating Center
Official title: Clinical Outcomes and Global Epidemiology -Data Coordinating Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acinetobacter Infections
Keywords: Acinetobacter
bloodstream infection
Isolate
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acinetobacter infection

Brief summary: The primary objective is to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include the following: To determine the impact of inactive empiric antimicrobial therapy, defined as receipt of empiric antimicrobial therapy with no in vitro activity against the offending isolate for at least 24hrs, on the outcome (end points defined below) of patients with Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or tigecycline if these agents were tested) on the outcome of patients with Acinetobacter bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome of patients with Acinetobacter bloodstream infection. To characterize the molecular epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are clonally related and to characterize the mechanisms of resistance in Acinetobacter on a global scale.

Detailed description: Medical records will be reviewed and information collected from charts to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. 24 sites will participate and all information will be loaded into a password protected database.

Eligibility criteria: Inclusion Criteria:

* Acinetobacter bloodstream infection

Exclusion Criteria:

* Does not meet entry criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: David Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01140763: Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Official title: Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Breast Diseases
Keywords: metastasis
Lead sponsor: Sysmex America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Brief summary: This is a study to evaluate the incidence of sampling bias during pathologic assessment of sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue slices are completely analyzed by histopathology (at 200 µm sections). The sponsor and investigators would like to determine how often small cancer deposits are present in one slice but not the other. The data will provide an empirical estimate of the incidence of tissue sampling bias inherent in using different tissue sections for analysis. The data will also show how varying degrees of detail in evaluating the sentinel lymph nodes (SLN) with histopathology methods will impact the degree of agreement.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* Diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel lymph node dissection
* Subjects (or the subject's legal representative) who have read, understood (to the best of their ability) and signed the informed consent form.

Exclusion Criteria:

* Subjects diagnosed pre-surgically with large or locally advanced (T3 \& T4) breast cancer
* Pregnant subjects, confirmed by interview with either subject or treating physician
* Subjects diagnosed with inflammatory breast cancer
* Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done
* Subjects with clinically suspicious, palpable axillary lymph nodes
* Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
* Subjects who have received pre-operative systemic therapy
* Subjects who are incapable of providing written informed consent
* Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).

Primary outcomes:
measure: Prospectively assess the agreement of histopathology results on tissue sections taken from different slices of SLNs removed using standard SLN biopsy procedures.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Breast Care Specialist, PC
state: Pennsylvania
Study officials:
References: