louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01232088: Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling
Official title: Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Labelling
Keywords: drug labelling
standardized drug syringe labelling
European ICU
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Members of the European Society of Intensive Care Medicine (ESICM)

Brief summary: Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338). Standardized color coded labels for user applied syringes enjoy strong support from many health professionals, thinking that this might increase patient safety. Whether this is true or not warrants further research.


Eligibility criteria: Inclusion Criteria:

Members of the European Society of Intensive Care Medicine (ESICM)

Primary outcomes:
measure: The primary objective is to assess if standardized drug syringe labelling is used in European ICUs.
timeFrame: A period of 90 days.
Secondary outcomes:
measure: The second objectives is to assess 1. if standards for drug syringe labelling are similar in European ICUs and 2. if users expect that standardized drug syringe labelling should be delivered by the pharmaceutical industry.
timeFrame: A period of 90 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Virchow Klinikum/Campus Charité Mitte
Study officials:
References:
citation: Valentin A, Capuzzo M, Guidet B, Moreno R, Metnitz B, Bauer P, Metnitz P; Research Group on Quality Improvement of the European Society of Intensive Care Medicine (ESICM); Sentinel Events Evaluation (SEE) Study Investigators. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009 Mar 12;338:b814. doi: 10.1136/bmj.b814.
citation: Balzer F, Wickboldt N, Spies C, Walder B, Goncerut J, Citerio G, Rhodes A, Kastrup M, Boemke W. Standardised drug labelling in intensive care: results of an international survey among ESICM members. Intensive Care Med. 2012 Aug;38(8):1298-305. doi: 10.1007/s00134-012-2569-1. Epub 2012 Apr 20.
Clinical trial NCT05281588: Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement
Official title: Effects of Micro-osteoperforations on the Upper Incisors' Retraction: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Tooth Movement
Keywords: Micro-osteoperforations
Orthodontic incisors retraction
Lead sponsor: Pontifícia Universidade Católica de Minas Gerais
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2022-03-16
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.

Detailed description: This single-centered randomized clinical trial evaluated the effects of micro-osteoperforations in the retraction of maxillary incisors in patients who required the extraction of the first premolars to correct malocclusion. The canine retraction was performed in a previous step. The possible effects of micro-osteoperforantions in the following parameters were evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

Eligibility criteria: Inclusion Criteria:

* both male and female subjects
* 16 or more years old
* orthodontic need of upper incisors extractions
* presence of all upper permanent teeth with exception of the third molars.

Exclusion Criteria:

* diseases and medications that were likely to affect bone biology
* pregnancy
* poor oral hygiene
* previous orthodontic treatment
* evidence of bone loss
* active periodontal disease
* smoking
* syndromes or cleft patients
* severe crowding or Class II malocclusion (Pg-Nper \> 18 mm, ANB \> 7º, SN-GoGn \> 38º e overjet \> 10 mm).

Primary outcomes:
measure: Anteroposterior displacement of the upper incisors
timeFrame: Up to 4 months
measure: Space closure
timeFrame: Up to 4 months
Secondary outcomes:
measure: First molars anchorage loss
timeFrame: Up to 4 months
measure: Changes of the inclination of the central incisors
timeFrame: Up to 4 months
measure: Changes of the length of the central incisors
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pontifícia Universidade Católica de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Pontifícia Universidade Católica de Minas Gerais
name: Rodrigo V Soares, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00371488: GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
Official title: Phase I Study of Lapatinib in Combination With Trastuzumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: ErbB2
Stage IV breast cancer
ErbB1
breast cancer
lapatinib
Herceptin
trastuzumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.


Eligibility criteria: Inclusion criteria:

* Patients with confirmed breast cancer who have received prior trastuzumab.
* Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

* Patients with certain heart problems.

Primary outcomes:
measure: Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
timeFrame: 6 Months
Secondary outcomes:
measure: Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue
timeFrame: 6 Months
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01401088: Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Official title: Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Keywords: patient with refractory glaucoma
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.

Detailed description: Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
* Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
* Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
* IOP≥18 mm of Hg with or without anti glaucoma medications
* If taking glaucoma medications, stable dose for 6 weeks

Exclusion Criteria:

* Age\<18 years
* Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
* Corneal abnormalities that would preclude accurate IOP readings
* Uncontrolled systemic diseases
* Endothelial cell count\<1800cells/mm
* Any other active ocular disease,(active uveitis, ocular infection)

Primary outcomes:
measure: Intra Ocular Pressure (IOP)
timeFrame: One year
Secondary outcomes:
measure: Success rate
timeFrame: one year
measure: Number of patients with adverse events as a measure of safety
timeFrame: one year
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamilnadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Dr. Prashanth Ranganath, MBBS., MS.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04862988: Reliability and Validity of Urdu Version of Global Physical Activity Questionnaire (GPAQ-U)
Official title: Reliability and Validity of Urdu Version of Global Physical Activity Questionnaire (GPAQ-U)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: GPAQ
reliability,
Validity
Urdu
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 101
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students, because they are usually engaged in their studies and have no enough time to do any physical activity resulting in decline in their overall health status.

Brief summary: The GPAQ questionnaire is used to measure the physical activity. In this study, Investigators will observe the reliability and validity of global physical activity questionnaire in Urdu language in Pakistan among students to assess physical activity.

Detailed description: The aim of study is to translate and culturally adapt Global physical Activity Questionnaire (GPAQ) into Urdu language and secondly to investigate the reliability and validity of GPAQ in Pakistan among university students. This study will be cross sectional survey study in which convenience sampling technique will be used.

The results of study will help to know the validity and reliability of GPAQ in Urdu version among students in Pakistan. The reliability of the questionnaire will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient with 100 patients

Eligibility criteria: Inclusion Criteria:

- Male and female aged over 18 years Pakistani national and native Urdu speakers Able to read and understand Urdu Studying in University level

Exclusion Criteria:

Male or female having any disability Any recent illness or any injury

Primary outcomes:
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: 1st day
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: 2nd day
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 1st day
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab, Pakistan
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT04850209: The Impact of WeChat Group Patient Education on the Eradication Rate of Helicobacter Pylori
Official title: The Impact of Interactive Patient Education Based on WeChat Group on the Eradication Rate of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Helicobacter Pylori Eradication
Patient Education
Keywords: helicobacter pylori
eradication
patient education
Wechat group
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two randomized parallel groups in this study, control group and Wechat group.
Primary purpose: TREATMENT

Brief summary: In this study, effects of oral and written education, WeChat education plus oral and written education on Helicobacter pylori eradication will be compared in a randomized way.

Detailed description: There are two randomized parallel groups in this study, control group and Wechat group.All of the patients will be treated with Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate. In control group,the patients will be educated by oral and written way about the regimen. In Wechat group, the patients will be educated by Wechat oral and written way. Then, the eradication rates, compliance, adverse events, patients' satisfaction and experience will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. aged between 18 and 75 years old;
2. H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.

Exclusion Criteria:

1. previous therapy for H. pylori;
2. with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study;
3. history of gastric surgery,
4. pregnancy or lactation;
5. the use of PPI or antibiotics during the 4 weeks prior to enrolment;
6. previous history of allergic reactions to any of the medications used in this protocol;
7. unable to use smartphone and wechat
8. unwilling or incapable to provide informed consents.

Primary outcomes:
measure: eradication rate in each group
timeFrame: 2 months
Secondary outcomes:
measure: prevalence of adverse events
timeFrame: 14 days
Other outcomes:
measure: compliance of patients in the two groups
timeFrame: 14 days
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
References:
Clinical trial NCT05118009: Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
Official title: Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction, Acute
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 43176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based supporting tool for improving the diagnosis and management of ST-elevation myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patients in emergency department or inpatient department.
* Patients recieved at least 1 ECG examination.

Exclusion Criteria:

* The patients recieved ECG at the period of inactive AI-ECG system.

Primary outcomes:
measure: E2C (ECG to coronary angiography) time
timeFrame: Within 6 hours
Secondary outcomes:
measure: E2B (ECG to primary percutaneous coronary intervention) time
timeFrame: Within 6 hours
measure: D2B (Door to Balloon Time) time
timeFrame: Within 6 hours
measure: D2C (Door to coronary angiography) time
timeFrame: Within 6 hours
measure: Ejection fractrion
timeFrame: Within 3 days
measure: Highest concentration of high-sensitivity cardiac troponin I
timeFrame: Within 3 days
measure: Highest concentration of creatine kinase
timeFrame: Within 3 days
measure: Length of hospitalization
timeFrame: Within 28 days
measure: Number of CAG event
timeFrame: Within 6 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Defense Medical Center
Study officials:
References:
Clinical trial NCT06540209: Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients
Official title: Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Watery Diarrhea
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

Detailed description: The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender
* Aged 3 months to 5 years
* With acute watery diarrhea last less fewer than 14 days
* Presenting with mild to moderate dehydration

Exclusion Criteria:

* Patients with a history of blood or pus in their stools
* History of recent antibiotic or probiotic treatment
* Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
* Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii

Primary outcomes:
measure: Stool frequency
timeFrame: 5 days
measure: Stool consistency
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Child Health Sciences, The Children's Hospital
state: Punjab
Study officials:
affiliation: University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
name: Wajiha Rizwan, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
name: Muhammad Tufail, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
name: Azher Abbas Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01296009: Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Official title: Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: In Vitro Fertilization and Embryo Transfer
Keywords: embryonic implantation
endometrial receptivity
traditional Chinese medicines
in vitro fertilization-embryo transfer
pregnant rate
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2011-02-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation in the patients who have underwent in vitro fertilization and embryo transfer, the investigators compare the pregnancy rate in traditional Chinese medicine group and control group. The hypothesis is that pregnancy rate in traditional Chinese medicine group is higher than the control group.

Detailed description: To demonstrate the impact of traditional Chinese medicine (TCM) on embryo implantation, the investigators perform a prospective randomized study on patients who have underwent in vitro fertilization and embryo transfer (IVF-ET) in the Reproductive Medical Center of the Remin Hospital Wuhan University in the next six months. These patients were randomly divided into two groups, one group was given traditional Chinese medicine, that is, ten days oral administration of Zhuyun recipe from the day after HCG injection. The second group without any treatment, and then the pregnancy rate were observed. Frozen embryo transfer for patients do the same treatment, measured indices were also the same in both groups. Our hypothesis is that Zhuyun recipe is beneficial for embryo implantation in IVF-ET patients, it can be found that pregnancy rate in traditional Chinese medicine group is higher than the control group.

Eligibility criteria: Inclusion Criteria:

1. aged 18-35 years old
2. undergo IVF/ICSI-ET treatment
3. undergo fresh/ frozen embryos transplantation

Exclusion Criteria:

1. the numbers of embryos transplantation were more than one
2. serum estradiol level \> 5000 pg/ml and progesterone level \> 9. 54 nmol/L on the day of HCG administration

Primary outcomes:
measure: pregnancy rate
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Jing Yang, Ph.D
role: STUDY_CHAIR
References: