louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02897856: Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
Official title: Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seizures
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.

Detailed description: Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.

In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.

Eligibility criteria: Inclusion Criteria:

* Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.

Exclusion Criteria:

* Cardiac arrest
* Head trauma
* Drowning
* Congenital heart disease
* Inborn errors of metabolism
* Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)
* Hemodynamic instability
* Allergy to benzodiazepines
* Focal seizures with preserved level of consciousness

Primary outcomes:
measure: Cessation of seizure activity five minutes after treatment with study medication.
timeFrame: five minutes
Secondary outcomes:
measure: Major side effects.
timeFrame: 2 hours after cessation of seizures.
measure: Duration of seizure.
timeFrame: 5 minutes
measure: Recurrence of seizure activity within one hour after treatment with study medication.
timeFrame: one hour
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
Study officials:
References:
Clinical trial NCT01221909: Tranexamic Acid in Dacryocystorhinostomy
Official title: Single Dose Tranexamic Acid for Dacryocystorhinostomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasolacrimal Tract Obstruction
Keywords: bleeding
dacryocystorhinostomy
operative duration
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study.

The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.


Eligibility criteria: Inclusion Criteria:

* obstruction of nasolacrimal pathway
* eligible for DCR surgery
* 18 years of age or older

Exclusion Criteria:

* warfarin treatment
* renal insufficiency
* pregnancy
* mental retardation
* tendency to bleed
* thromboembolic disease
* thrombophilia

Primary outcomes:
measure: Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.
timeFrame: Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.
Secondary outcomes:
measure: Late onset postoperative epistaxis or periorbital hematoma
timeFrame: 8 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dept. of Ophthalmology, HaEmek medical center
Study officials:
References:
citation: Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.
citation: Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. doi: 10.2165/00003495-200363130-00008.
citation: Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
Clinical trial NCT04859309: Activating Older People After a Hip Fracture
Official title: Activating Older People After a Hip Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: Tele-rehabilitation
Occupational therapy
Physiotherapy
Physical exercise
Function
Quality of life
Informal Caregiver burden
Information and Communication Technologies
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Amgen
name: Institut de formació contínua - IL3
name: University of Barcelona
name: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
name: EIT Health
name: Biohealth Research Institute in Granada (ibs.GRANADA)
First posted: 2021-04-26
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.

The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.


Eligibility criteria: Inclusion Criteria:

* Have hip fracture surgery
* Age equal to or greater than 65 years
* Are allowed weight-bearing at 48 hours after surgery
* Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure \[FIM\] index scored more than 90 points)
* Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
* Basic management of the mobile phone
* Have signed an informed consent.

Exclusion Criteria:

* Presence of low cognitive level (Pfeiffer test score lower than 4 points)
* Being dependent on the activities of daily living before the hip (Functional Independence Measure \[FIM\] index scored less than 60 points)
* Being institutionalized
* Post-surgery complications
* Terminal disease
* Age under 65 years

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: The primary outcome will be followed over 12 weeks.
Secondary outcomes:
measure: EuroQoL 5D Quality of Life questionnaire
timeFrame: 12 weeks
measure: Functional Independence Measure
timeFrame: 12 weeks
measure: Short Falls Efficacy Scale-International (SFES-I)
timeFrame: 12 weeks
measure: New Mobility Score (NMS)
timeFrame: 12 weeks
measure: The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer
timeFrame: 12 weeks
measure: Visual Analogue Scale for Pain (VAS Pain)
timeFrame: 12 weeks
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: International Fitness Scale (IFIS)
timeFrame: 12 weeks
measure: Zarit Burden Interview
timeFrame: 12 weeks
measure: The Low Back Pain Disability Scale (Oswestry)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Andalusian Public Health System
Study officials:
References:
Clinical trial NCT01160809: Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Ethiopia
Official title: Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Southern Ethiopia: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Mosquito Repellent
Long Lasting Insecticidal Nets
Keywords: Malaria
Mosquito repellent
LLINs
Lead sponsor: Malaria Consortium, Ethiopia
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
name: Columbia University
name: Coalition Against Malaria in Ethiopia
First posted: 2010-07-12
Enrollment: 6082
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by household members would result in a 40% reduction in malaria prevalence compared with households that only use LLINs.

Detailed description: It has been recognized that the use of malaria preventive measures in combination with LLINs could improve the effectiveness of nets in preventing the disease. This study examined the effect of a combined use of mosquito repellent (i.e., Buzz Off) and LLINs on malaria prevalence in an area of unstable and seasonal malaria transmission.

Eligibility criteria: Inclusion Criteria:

* All volunteer household members

Exclusion Criteria:

* Infants less than two months
* Not in the study area

Primary outcomes:
measure: Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection
Secondary outcomes:
measure: Household ownership and utilization of LLINs
Other outcomes:
Locations:
city: Awassa
country: Ethiopia
facility: SNNPR, Ethiopia
state: Snnpr
Study officials:
References:
citation: Deressa W, Yihdego YY, Kebede Z, Batisso E, Tekalegne A, Dagne GA. Effect of combining mosquito repellent and insecticide treated net on malaria prevalence in Southern Ethiopia: a cluster-randomised trial. Parasit Vectors. 2014 Mar 28;7:132. doi: 10.1186/1756-3305-7-132.
Clinical trial NCT00655109: A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis
Official title: A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conjunctivitis, Allergic
Keywords: Allergic conjunctivitis
Allergic rhinoconjunctivitis
Lead sponsor: Greiner, Jack V., OD DO PhD
Sponsor class: INDIV
First posted: 2008-04-09
Enrollment: 60
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: To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Detailed description: Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions and attend all study visits
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy, or lactating
* Use of disallowed medications

Primary outcomes:
measure: Ocular itching
timeFrame: Minutes following CAC
Secondary outcomes:
measure: Ocular redness
timeFrame: Minutes following CAC
Other outcomes:
Locations:
city: North Andover
country: United States
facility: Ophthalmic Research Associates, Inc
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Jack V Greiner, OD, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06840509: BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
Official title: BIO|CONCEPT.CorSky Family, First in Human Study for the CorSky ICD Family
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tachycardia
Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Biotronik SE & Co. KG
First posted: 2025-02-21
Enrollment: 50
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 goal of this exploratory study is to test the preliminary safety and product performance of the new CorSky ICD family in subjects that require an ICD or cardiac resynchronization therapy with defibrillation (CRT-D). The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the ICDs will be done according to the participant´s therapeutical needs.


Eligibility criteria: Inclusion Criteria:

* Standard indication for ICD or CRT-D therapy according to clinical guidelines
* Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all on-site follow-up visits at the study site Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

* For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia
* For VR-T DX and CRT-DX: Patients requiring atrial pacing
* Planned for His-Bundle-Pacing
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation according to the definition given below 2,3
* Life-expectancy less than 12 months

Primary outcomes:
measure: Serious adverse device effect (SADE)-free rate after 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03851809: Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
Official title: A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Brain Injury
Keywords: traditional chinese medicine combination treatment
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.

Detailed description: This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study

Eligibility criteria: Inclusion Criteria:

* traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset;
* an initial score of 3-12 points of GCS score;
* adults between 18 to 80 years old;
* and signed informed consent form.

Exclusion Criteria:

* after 14 days of onset;
* a history of previous TBI or stroke;
* intracranial aneurysm or arteriovenous malformation ruptured;
* combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels);
* other severe disease such as heart or kidney failure;
* previous diagnosed cancer; and pregnant women.

Primary outcomes:
measure: Ventilator use
timeFrame: 1 month
measure: ICU stay
timeFrame: 1 month
measure: Glasgow coma scale
timeFrame: 1 month
measure: Disability rating scale
timeFrame: 1 month
measure: modified Rankin scale
timeFrame: 1 month
measure: mortality
timeFrame: 1 month
Secondary outcomes:
measure: Glasgow coma scale
timeFrame: 6 month
measure: modified Rankin scale
timeFrame: 6 month
measure: Disability rating scale
timeFrame: 6 month
measure: Barthel index
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06198309: Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease Severe
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 365
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient with severe chronic obstructive pulmonary disease who visited the Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University since January 2023

Brief summary: This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.


Eligibility criteria: Inclusion Criteria:

1. Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1/FVC\&lt;70%, FEV1% predicted value ≤ 50% after Bronchiectasis)
2. Age\&gt;40 years old
3. COPD stable for more than 4 weeks
4. Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month
5. Patient informed and signed consent form

Exclusion Criteria:

1. Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis
2. Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)
3. History of chronic diarrhea or constipation
4. History of Gastrointestinal Surgery
5. Using probiotics or antibiotics within the past 4 weeks
6. No history of using oral hormones or traditional Chinese medicine in the past three months
7. Pregnancy or lactation

Primary outcomes:
measure: Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve.
timeFrame: A year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03008109: Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC
Official title: Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Cancer
Lung Cancer, Nonsmall Cell
Keywords: EGFR-TKI
Recombinant human endostatin
Lead sponsor: Air Force General Hospital of the PLA
Sponsor class: OTHER_GOV
First posted: 2017-01-02
Enrollment: 80
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: EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS （progression-free survival） , the OS （ overall survival） is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.


Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions

Exclusion Criteria:

-

Primary outcomes:
measure: progression-free survival
timeFrame: 18 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gridelli C, Rossi A, Ciardiello F, De Marinis F, Crino L, Morabito A, Morgillo F, Montanino A, Daniele G, Piccirillo MC, Normanno N, Gallo C, Perrone F. BEVERLY: Rationale and Design of a Randomized Open-Label Phase III Trial Comparing Bevacizumab Plus Erlotinib Versus Erlotinib Alone as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2016 Sep;17(5):461-465. doi: 10.1016/j.cllc.2016.04.001. Epub 2016 Apr 22.