louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01697462: An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
Official title: Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer

Brief summary: This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Receiving Xeloda according to registered indication

Exclusion Criteria:

* Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics

Primary outcomes:
measure: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to end of study (up to 42 months)
Secondary outcomes:
measure: Percentage of Participants With Disease Progression
timeFrame: Baseline to progressive disease or death (up to 42 months)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to progressive disease or death (up to 42 months)
measure: Number of Participants With Hand-Foot Syndrome (HFS)
timeFrame: Baseline up to end of study (up to 42 months)
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01238562: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
Official title: A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy Patients
Keywords: cancer patient
chemotherapy
carboplatin
taxol
cyclophosphamide
pharmorubicin
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2010-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).


Eligibility criteria: Inclusion Criteria:

* Age: 18～70yrs
* Signed informed consent
* Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
* Karnofsky score ≥70
* Life expectancy \>3 months
* WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
* Normal coagulation function, no evidences of hemorrhage
* Normal liver, heart, kidney function

Exclusion Criteria:

* Pregnant or lactating females
* Proven active infectious diseases (e.g. viral hepatitis, TB)
* Not adequately controlled infections
* Known hypersensitivity to filgrastim or any other components of the study drug
* Unstable or uncontrolled cardiac disease or hypertension
* Currently participated in any other clinical trials
* Patients with previous or expected to receive systemic radiotherapy
* Evidence of metastatic disease in bone marrow, brain, et al
* Alcoholic or drug abusers
* Other conditions which in the opinion of the investigator preclude enrollment into the study

Primary outcomes:
measure: Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
timeFrame: each cycle
Secondary outcomes:
measure: Measurement of serum concentration of drugs for Pharmacokinetic study.
timeFrame: each cycle
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shi Yuankai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874962: Improvements in Pneumonia Status After Oral Care Intervention in Taiwan
Official title: Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: Oral care intervention
Nursing home residents
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 220
Sex: ALL
Minimum age (years): 51
Maximum age (years): 102
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The correlation between improvement in oral health, reduction in oral bacterial concentration, and status of pneumonia hospitalization remains unclear. To determine the effects of professional oral care intervention on the index of oral health, salivary and sputum bacterial concentrations, and pneumonia hospitalization status of nursing home residents using a quasi-experimental study. Two nursing homes were on demand selected as the intervention and control groups; in the intervention group, weekly professional oral care was administered in addition to regular oral care by trained dental hygienists. Demographic data and oral health status were analyzed. Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* 51 year-old and above
* Being bedridden for ≥ 6 months
* Positive sputum production
* Difficulty in swallowing reported by caregivers

Exclusion Criteria:

* Below 51 year-old
* Patients or family refused any oral care

Primary outcomes:
measure: Pneumonia hospitalization status
timeFrame: 2 hours
measure: Bacterial concentrations
timeFrame: 3 hours
Secondary outcomes:
measure: Oral health examinations
timeFrame: 3 hours
measure: Demographic data
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Shun-Te Huang, Professor
role: STUDY_CHAIR
References:
citation: Cao Y, Liu C, Lin J, Ng L, Needleman I, Walsh T, Li C. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev. 2022 Nov 16;11(11):CD012416. doi: 10.1002/14651858.CD012416.pub3.
citation: Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z.
Clinical trial NCT01589562: Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
Official title: A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fed Conditions in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2012-05-02
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of taking megestrol

Primary outcomes:
measure: AUC of Megace 800mg/20mL
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
measure: AUC of DW-ES(B) 625mg/5mL
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
measure: Cmax of Megace 800mg/20mL
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
measure: Cmax of DW-ES(B) 625mg/5mL
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT05372562: Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
Official title: Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection

Brief summary: Patients who were diagnosed as postoperative CME and administrated with intravitreal OZURDEX injection were reviewed. Outcome will include best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded.

Detailed description: Patients who were diagnosed as postoperative CME after uneventful intraocular surgery and administrated with intravitreal OZURDEX injection were reviewed. All patients underwent ophthalmic examinations at the initial visit and were followed up at months 1, 2, 3 and 6 with measurement of best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded. Risk factors of recurrent CME were analyzed

Eligibility criteria: Inclusion Criteria:

* patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection were reviewed.

Exclusion Criteria:

* patients with retinal vascular diseases, including retinal vein occlusion (RVO), diabetic retinopathy (DR), hypertensive retinopathy, retinal artery occlusion (RAO), Coats disease, Eales disease;
* patients with macular disease before surgery, such as age-related macular degeneration (ARMD), macular choroidal neovascularization (CNV), myopic macular degeneration, macular hole (MH), epiretinal membrane(ERM);
* patients with uveitis before surgery, including anterior, intermediate, posterior and generalized uveitis;
* patients with autoimmune disease, such as ankylosing spondylitis (AS), Vogt-Koyanagi-Harada (VKH) disease, Behcet disease.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hosipital
state: Beijing
Study officials:
References:
Clinical trial NCT04298762: The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage
Official title: The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2020-03-06
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Documenting cancer stage is the most important determinant of treatment approach and survival for cancer patients. However, oncologists do not routinely document a patient's cancer stage in the structured field in electronic health records. This quality improvement pilot study evaluated the impact of sending an email to physicians at a cancer center of a large academic hospital with individualized data on their rates of cancer stage documentation using a structured field. The investigators assessed patient-level documentation and physician-level rates of staging documentation over 15 months including a three-month pre-period, a six-month pilot phase and a six-month follow-up period. The investigators also estimated staging documentation rates separately for each physician's new versus established patients.


Eligibility criteria: Inclusion Criteria:

* Attending physicians who had been at one of three sites of hospital between January - August 2018

Exclusion Criteria:

* Physicians treating cancer patients where American Joint Committee on Cancer (AJCC) staging modules were less clinically relevant
* Physicians with low clinical volume (\<5 patients over 3 months)
* Physicians without any outpatient visits

Primary outcomes:
measure: Measuring if a patient's cancer stage was documented in a structured field in the Electronic Health Record on the date of the patient's first ambulatory care visit
timeFrame: 15 months
Secondary outcomes:
measure: Staging documentation rate (monthly)
timeFrame: 15 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Anna Sinaiko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00679562: Lactacyd Radiance (Lactic Acid) Prophetic Patch Test
Official title: Skin Irritation : Prophetic Patch Test of Lactacyd Radiance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primay objective:

To evaluate the potential of the products in eliciting adverse skin reaction.


Eligibility criteria: Inclusion Criteria:

* Test area should have a healthy or normal skin
* Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
* Not currently use of steroid or any medication during the test

Exclusion Criteria:

* History of Allergy or Allergic Reaction to:

  * Hey Fever
  * Asthma
  * Poison Ivy
  * Food
  * Cosmetics
  * Soap
  * Detergent
  * Metal
  * Jewelry
  * Lather
  * Fabric
  * Medication

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Reaction after patch removal.
timeFrame: at 15-30 minutes and day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Taweeporn NATESUMROENG
role: STUDY_DIRECTOR
References:
Clinical trial NCT01637662: Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official title: Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-40
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease

Primary outcomes:
measure: Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion.
timeFrame: Every 10 min.
Secondary outcomes:
measure: All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004)
timeFrame: 10 hours after discharge
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
References:
Clinical trial NCT02632162: Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery
Official title: Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disordered Breathing
Lead sponsor: Zürcher RehaZentrum Wald
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cardiac surgery \< 2 weeks

Brief summary: Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac Rehabilitation and then after 3 weeks and 3 months.

Detailed description: Objective(s) of the project

* Evaluate the prevalence of sleep apnea after cardiac surgery
* Compare results interindividually (group A vs. group B) and intraindividually (longitudinal assessment after 3 months)

Outcome(s)

* Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery
* composite endpoint of events at 3 months (cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, revascularisation procedure, new atrial fibrillation and stroke)
* change in 6-minute walking test (6-MWT)
* impact of heart surgery on sleep apnoe

Eligibility criteria: Inclusion Criteria:

* cardiac surgery or orthopedic surgery \<2 weeks

Exclusion Criteria:

* known SDB

Primary outcomes:
measure: Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device
timeFrame: day 1, day 20, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wald
country: Switzerland
facility: Zürcher RehaZentrum Wald
Study officials:
affiliation: Zürcher RehaZentrum Wald
name: Matthias Hermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226862: Advancing Telestroke Care: A Prospective Observational Study
Official title: Advancing Telestroke Care: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Telemedicine
Telestroke
Lead sponsor: National Stroke Association, United States
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Mayo Clinic
name: Swedish Medical Center
name: University of Utah
name: California Pacific Medical Center
First posted: 2010-10-22
Enrollment: 508
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: 600 subjects meeting inclusion and exclusion criteria will be enrolled consecutively over approximately 12 months and followed for 90 days post-stroke.

Brief summary: This study will promote the development and economic sustainability of telemedicine for acute stroke treatment.

Detailed description: The goal of this study is to promote the development and economic sustainability of telemedicine for acute stroke treatment. The study's objectives are 1) to determine if the use of telemedicine consultations for stroke patients will improve their care per guidelines compared to stroke patients treated by control hospitals; and 2) to determine if the care per guidelines provided via telemedicine consultations for stroke patients will be similar or equivalent to care per guidelines provided to stroke patients treated at hub hospitals.

The Advancing Telestroke Care study will establish treatment and outcomes in three distinct study cohorts: hub telemedicine hospital, spoke telemedicine hospital and non-telemedicine control hospital.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old
* Acute ischemic stroke within 12 hours of stroke onset

Exclusion Criteria:

* Life expectancy less than 90 days
* Patient unwilling to participate in study

Primary outcomes:
measure: IV tPA administration
timeFrame: Day 7/Discharge
Secondary outcomes:
measure: Multiple Study Assessments
timeFrame: Day 7 and/or Day 30 and/or Day 90 and/or at discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California, Los Angeles
name: Gene Sung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: