louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02074085: Measuring the Incidence of Hospital Readmissions Based on Adverse Drug Events
Official title: Measuring the Incidence of Hospital Readmissions, Caused by Adverse Drug Events (ADE) Due to Anticoagulants in Vzw Jessa Hospital (Belgium)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incidence of Readmissions
ADE's Due to Anticoagulants
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2014-02-28
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received an anticoagulant on their last day of admission

Brief summary: An ADE is defined as harm caused by a drug or the inappropriate use of a drug. Retrospective record reviews in several countries have shown that anticoagulants frequently lead to hospital readmissions. In this study a hospital readmission is defined as an admission to the emergency department of the Jessa hospital. The objective of this study is to determine the incidence of one week and 30-day readmissions caused by (preventable) ADE's due to anticoagulants.


Eligibility criteria: Inclusion Criteria:

1. Patients who received an anticoagulant on their last day of admission
2. Patients who were readmitted within 30 days
3. Patients who were diagnosed using the pathology registration of the emergency department of the Jessa hospital

Exclusion Criteria:

1. Patients who didn't receive an anticoagulant on their last day of admission
2. Patients who were not readmitted within 30 days
3. Patients who were not diagnosed using the pathology registration of the emergency department of the Jessa hospital
4. Patients with missing data

Primary outcomes:
measure: incidence of readmissions within one week caused by ADE's due to anticoagulants
timeFrame: up to one week
measure: incidence of readmissions within 30 days caused by ADE's due to anticoagulants
timeFrame: up to 1 month
measure: incidence of preventable ADE's leading to readmission
timeFrame: week 1, month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Jessa Hospital
name: Martijn Droogmans, pharmacist
role: STUDY_CHAIR
affiliation: Hasselt University
name: Kristel Marquet, drs
role: STUDY_CHAIR
affiliation: Jessa Hospital
name: Janne Theuwissen, pharmacist
role: STUDY_CHAIR
References:
Clinical trial NCT01035385: Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
Official title: Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Liver Metastasis
Keywords: FOFLOX4
resectable liver metastasis from colorectal cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.

Detailed description: To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:

   * Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
   * Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
2. Age of≥18 and ≤80
3. ECOG≤2
4. Signed written informed consent

Exclusion Criteria:

1. Peripheral neuropathy(CTC\>1)
2. Had a neurological or mental disorders
3. Active infection
4. Allergy to Platinum-based and other drugs
5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
6. Pregnant or nursing patients

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Lin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884585: Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Conjunctivitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 176
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
* Be on stable doses of your current AKC medications for at least 2 weeks

Exclusion Criteria:

* You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
* You are pregnant, breastfeeding, or planning to become pregnant during the study
* You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks

Primary outcomes:
measure: Percentage of Treatment Responders
timeFrame: Baseline, Month 2
Secondary outcomes:
measure: Percentage of Punctate Corneal Staining Responders
timeFrame: Month 2
measure: Percentage of Patients With an Improvement in the Composite Symptom Score
timeFrame: Baseline, Month 2
measure: Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
timeFrame: Baseline, Month 2
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Randwick
country: Australia
state: New South Wales
city: Ottawa
country: Canada
state: Ontario
city: Prague
country: Czech Republic
city: Dijon
country: France
state: Burgundy
city: Munich
country: Germany
state: Bavaria
city: Bangalore
country: India
state: Karnataka
city: Tel Aviv
country: Israel
city: Rome
country: Italy
city: Wellington
country: New Zealand
city: Valladolid
country: Spain
city: Newcastle-upon-tyne
country: United Kingdom
state: Tyne and Wear
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02497885: Seroprevalence of MERS-CoV IgG in Healthcare Workers
Official title: Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infections
Keywords: MERS
healthcare personnel
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Healthcare-personnel

Brief summary: The investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of Middle-East respiratory syndrome. The investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed MERS patients had been treated.

The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

Detailed description: We aim to deduct the seroprevalence of healthcare-personnel (HCP) who had participated in treatment of confirmed patients of Middle-East respiratory syndrome.

In first step, we collected the base-line (pre-exposure) serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated. Pre-exposure serum was collected in a few centers. If the serum was drawn within 3 weeks from initial exposure, then the serum was considered adequate as pre-exposure. (Because, antibody against the MERS-CoV would be produced after more the 17-21 days of exposure). The serum was frozen.

In second step, we will collect the post-exposure serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated or detected. We plan to include 25-30 centers. The timing of sample collection is 6-8 weeks after last contact with confirmed MERS patients. The serum will also freeze.

In third step, we will assay the presence of antibody in collected sample. We will use MERS-CoV ELISA kit (EUROIMMUNE co.) as screening test and MERS-CoV IFA kit (EUROIMMUNE co.) as confirm test.

Eligibility criteria: Inclusion Criteria:

* Healthcare-personnel who are working for hospitals in which confirmed MERS patients were treated or detected
* Close contact with confirmed patient(s).
* Agree to informed consent

Exclusion Criteria:

* disagree to consent
* confirmed MERS patient

Primary outcomes:
measure: IgG(+)
timeFrame: up to 4-5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha womans university mokdong hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Hee Jung Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109485: Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 42
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Patients whose parents or guardians can issue informed consent
* Patients aged over 7 and less than 16 at the baseline
* Patients confirmed to show type I allergy
* Patients with allergic conjunctivitis
* Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)

Exclusion Criteria:

* Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
* Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
* Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
* Patients having received continuous treatment with corticosteroid within 3 months
* Patients having received immunotherapy
* Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
* Patients having undergone ocular laser therapy within 3 months
* Unilaterally blind patients (best corrected visual acuity: below 0.01)
* Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
* Patients necessitating the use of contact lens during the study period
* Other patients judged by the attending physician as inappropriate for study

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 4 weeks
measure: Questionnaire about compliance with dosing instructions
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in score of subjective symptoms and objective findings
timeFrame: 4 weeks
measure: Questionnaire about stinging after instillation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Call Center For Trial Locations
Study officials:
affiliation: Alcon Research
name: Eriko Chono
role: STUDY_DIRECTOR
References:
Clinical trial NCT03212885: Stimulation of the Rostral Zona Incerta for Parkinson's Disease
Official title: Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Clinical Efficacy and Evaluation of Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom relief due to electrical stimulation of the brain. The target for the stimulation, in many cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in combination with the STN.

Detailed description: Deep brain stimulation (DBS) of an area of the brain called the subthalamic nucleus (STN) is an effective treatment in Parkinson's disease (PD). However, stimulating the STN can lead to unwanted side effects that involve muscle movements (dyskinesias) and behavior and mood problems. DBS of a different brain structure, called the rostral zona incerta (rZI), has been demonstrated to be as effective as stimulating the STN, without any unwanted side effects in several studies. However, there is great variability in reported efficacy and adverse effects of rZI stimulation likely due to challenges in locating this area in the brain. The goals of this study are 1) to develop an improved method for targeting the rZI 2) determine efficacy of rZI with STN stimulation compared with STN stimulation alone, 3) evaluate any stimulation adverse effects of combined stimulation of the rZI and STN.

Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease,
* No current deep brain stimulating electrodes

Exclusion Criteria:

* Other movement disorders,
* Parkinson's Disease with already implanted electrode.

Primary outcomes:
measure: Motor testing
timeFrame: 1 week
Secondary outcomes:
measure: Dyskinesias
timeFrame: 1 week
measure: Cognition
timeFrame: 1 week
measure: Depression
timeFrame: 1 week
measure: Anxiety
timeFrame: 1 week
measure: Suicide
timeFrame: 1 week
measure: Non-motor features of Parkinson's disease
timeFrame: 1 week
measure: Motor aspects of daily living
timeFrame: 1 week
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Drew S Kern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108885: Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
Official title: Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Neoplasm
Esophageal Neoplasms Malignancy Unspecified
Esophageal Neoplasms Malignant
Cancer of Esophagus
Cancer of the Esophagus
Esophageal Cancer
Esophagus Cancer
Neoplasm, Esophageal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergoing surgery and follow up at Mayo Clinic Rochester for esophageal cancer.

Brief summary: To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

Detailed description: Esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. While survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. Unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. However, quantifying cfDNA is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer.

To identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. From this data, the investigators will select 10-15 genes to focus their efforts. PCR primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer.

The investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Eligibility criteria: Inclusion Criteria:

* Esophageal Cancer any stage
* Age \>18 years old
* Willing and able to provide consent
* No prior history of neoadjuvant therapy for the esophageal cancer

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent

Primary outcomes:
measure: Esophageal Cancer Mutation
timeFrame: 5 years
Secondary outcomes:
measure: Marker for Recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shanda Blackmon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01031485: Bioactive Milk Peptides and Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage 1 Hypertension
Keywords: hypertension
blood pressure
milk peptides
bioactive peptides
randomized controlled trial
Lead sponsor: Valio Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
First posted: 2009-12-14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.


Eligibility criteria: Inclusion Criteria:

* age 30-60 years
* systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement
* apparently healthy

Exclusion Criteria:

* antihypertensive and lipid-lowering drugs
* unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension
* BMI \> 32 kg/m2
* milk allergy
* smoking
* alcohol abuse
* pregnancy, lactation
* simultaneous participation in other clinical trial

Primary outcomes:
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Valio Ltd
state: Uusimaa
Study officials:
References:
Clinical trial NCT06789185: Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery
Official title: Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 96
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.


Eligibility criteria: Inclusion Criteria:

1. laparoscopic inguinal hernia repair under general anesthesia
2. aged 24\~71 months
3. American Society of Anesthesiologists Physical Status I or II
4. body mass index for age between the 5th and 85th percentiles

Exclusion Criteria:

1. allergy to esketamine
2. abnormal liver or kidney function
3. glaucoma or neurological disorders
4. cardiovascular or endocrine dysfunction
5. asthma or respiratory infection in the last 2 weeks
6. developmental delay

Primary outcomes:
measure: The incidence of emergence delirium
timeFrame: Within up to 30 minutes after emergence from anesthesia
Secondary outcomes:
measure: Tracheal catheter extubation time
timeFrame: Within up to 30 minutes after operation
measure: emergence from anesthesia time
timeFrame: Within up to 30 minutes after operation
measure: The incidence of postoperative pain
timeFrame: Within up to 30 minutes after operation
measure: Recovery time
timeFrame: Within up to 50 minutes after operation
measure: The incidence of adverse effects
timeFrame: 24 hours after surgery.
measure: Blood pressure
timeFrame: Intraoperative and up to postoperative 20 minutes
measure: heart rate
timeFrame: Intraoperative and up to postoperative 20 minutes
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: