louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05969743: Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease
Official title: Letermovir Prophylaxis for CMV in Patients With Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation: a Proof of Concept Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Graft-versus-host-disease
CMV
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.

Detailed description: 42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

All the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir.

Patients will be evaluated biweekly until letermovir discontinuation. A PCR CMV test will be performed biweekly. Patients in whom clinically significant CMV infection (defined as CMV disease or CMV viremia leading to preemptive treatment) develop, will discontinue the trial regimen and begin anti-CMV therapy according to local practice. The threshold for preemptive treatment for CMV viremia will be \>1000 copies/ ml.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* After allogeneic transplantation
* Seropositive for CMV
* Who already received letermovir prophylaxis until day 100 without CMV reactivation
* Beyond day 100 after transplantation at enrollment
* With acute or chronic GVHD
* Daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at enrollment.
* Negative polymerase chain reaction (PCR) for CMV at enrollment
* Provided informed consent

Exclusion Criteria:

* Seronegative for CMV
* Positive PCR for CMV at enrollment
* Patient has previously had CMV reactivation under letermovir.

Primary outcomes:
measure: Incidence of CMV infection
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institution of Hematology, Rabin Medical Center
name: Moshe Yeshurun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308043: Deep Learning in Retinoblastoma Detection and Monitoring.
Official title: Deep Learning Computer-aided Detection System for Retinoblastoma Detection and Monitoring.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinoblastoma
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retinoblastoma patients undergo standard medical management.

Brief summary: Retinoblastoma is the most common eye cancer of childhood. Eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. In the current study, we develop a deep learning algorism that can simultaneously identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. This algorism will be validated through a prospectively collected dataset.

Detailed description: Retinoblastoma, the most common eye cancer of childhood, affects 1 in 15 000 to 1 in 18 000 live births. China has the second-largest number of patients with retinoblastoma in the world. Eye-preserving therapies have been used widely in China for approximately 15 years. Eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. However, the major amount of qualified ophthalmologists are concentrated in several medical centres. Deep learning based on Retcam examination that can identify retinoblastoma will reduce screening accuracy of the local hospitals and reduce monitoring wordload. In the current study, a deep learning algorism was developed that can simultaneously identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. This algorism will be validated through a prospectively collected dataset.

Eligibility criteria: Inclusion Criteria:

* Retinoblastoma patients undergo standard medical management.

Exclusion Criteria:

* The operators identified images non-assessable for a correct diagnosis, due to reasons such as blur and defocus, and excluded them from further analysis.

Primary outcomes:
measure: Diagnosis accurcy of deep learning algorism
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wen-Bin Wei
state: Beijing
Study officials:
References:
Clinical trial NCT06878638: Nitrate - Clopidogrel - Acute Coronary Syndrome
Official title: Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Keywords: Intravenous nitrate
clopidogrel
acute coronary syndrome
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute coronary syndrome patients

Brief summary: This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel.


Eligibility criteria: Inclusion Criteria:

* diagnosed with non-STEMI
* Patients aged 18 to 75 years
* positive troponin levels,
* blood pressure above 120/70 mmHg

Exclusion Criteria:

* Hemodynamically unstable and requiring urgent intervention,
* ST elevation on electrocardiography, atrial fibrillation,
* recurrent angina,
* use of narcotic analgesics (e.g., morphine), nitrates and glycoprotein IIb/IIIa inhibitors during hospitalization,
* history of coronary artery bypass graft (CABG) surgery,
* active infection,
* uncontrolled hypertension,
* diabetes, cerebrovascular accident, Use P2Y12 inhibitor, proton pump inhibitor, oral anticoagulant, statin, CYP enzyme-inducing or inhibiting drugs at the time of admission,
* active systemic disease (e.g., malignancy, thyroid disorders chronic inflammatory diseases, liver dysfunction),
* left ventricular systolic dysfunction (ejection fraction \<50%),
* glomerular filtration rate \<60 mL/min/1.73m2,
* allergy to ASA or clopidogrel, coagulopathy,
* platelet counts below 100,000/μl and hematocrit levels below 29%, or exceeding 52%.

Primary outcomes:
measure: Platelet Reactivity Unit level
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Hastanesi
Study officials:
References:
Clinical trial NCT00143338: To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Official title: A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2005-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Normal lung function

Exclusion Criteria:

* Smokers

Primary outcomes:
measure: To assess in patients with type 2 diabetes mellitus the effects, if any, on lung lining fluid cell count and differential within subjects after 12 weeks of inhaled insulin therapy compared to 12 weeks of subcutaneous short-acting therapy.
Secondary outcomes:
measure: (1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05433038: Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
Official title: Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterior Crossbite
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion

Detailed description: Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.

Eligibility criteria: Inclusion Criteria:

* All patients should satisfy the following criteria:-

  1. An age range from 18-22.
  2. Transverse maxillary deficiency.
  3. Crossbite (unilateral or bilateral)
  4. No previous orthodontic treatment.
  5. Good oral and general health.
  6. No systemic disease/ medication that could interfere with OTM.

Exclusion Criteria:

1. History of systemic and medical illness.
2. History of extraction of permanent teeth.
3. Previos orthodontic treatment.
4. Poor oral hygiene or periodontally compromised patient.
5. Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.

Primary outcomes:
measure: skeletally transverse measurement
timeFrame: from start of treatment until study completion an average of 1 year
measure: dentolinear measurement
timeFrame: from start of treatment until study completion an average of 1 year
measure: dentoangular measurement
timeFrame: from start of treatment until study completion an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar univesity
Study officials:
References:
Clinical trial NCT05395338: 1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients
Official title: 1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 12551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, AIS patient data from 80 stroke centres in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from January 2017 to March 2020 will be used.

Brief summary: The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.


Eligibility criteria: Inclusion criteria:

* Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020
* ≥ 18 years of age
* Diagnosed with AIS at admission
* Arrived or admitted to the hospital within 4.5 hours of symptom onset
* If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset

Exclusion criteria:

* Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC)
* Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment)
* Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
* Received endovascular treatment
* Received IV rt-PA after 4.5 hours of symptom onset

Primary outcomes:
measure: All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)
timeFrame: Up to 1 year.
Secondary outcomes:
measure: Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year
timeFrame: Up to 1 year.
measure: Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year
timeFrame: Up to 1 year.
measure: Percentage of Patients With mRS Score 5 to 6 at 1 Year
timeFrame: Up to 1 year.
measure: Distribution of mRS Score at 1 Year
timeFrame: Up to 1 year.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Boehringer Ingelheim (China) Investment Co., ltd.
Study officials:
References:
Clinical trial NCT06353438: Hydraulic Resistance and Older Adults
Official title: Implementation of a Community Based Exercise Program for Older Adults Using Hydraulic Resistance Equipment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Fall
Old Age; Debility
Muscle Weakness
Lead sponsor: College of Staten Island, the City University of New York
Sponsor class: OTHER
Collaborators: name: Bay Ridge Center
First posted: 2024-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:

* Does the use of hydraulic exercise equipment decrease fall risk in older adults?
* Does the use of hydraulic exercise equipment improve function in older adults?

Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Age 60+

Exclusion Criteria:

* Age \<60
* Neurological condition
* Surgery within last 6 months
* Current injury
* Inability to follow directions
* Inability to participate in physical activity for any medical reason

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
measure: Timed Up and Go
timeFrame: 1 week prior to 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test) start date and 1 week post intervention end date
measure: Tinetti Balance and Gait Assessment Tool
timeFrame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
measure: Lower Extremity Functional Scale
timeFrame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Secondary outcomes:
measure: Strength
timeFrame: 1 week prior to intervention start date and 1 week post intervention end date
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Bay Ridge Center
state: New York
Study officials:
affiliation: CUNY College of Staten Island
name: Amanda L Rotondo, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05920538: Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation
Official title: Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radial Artery Cannulation
Keywords: Nicardipine
radial artery
artery cannulation
ultrasound
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation


Eligibility criteria: Inclusion Criteria:

* age 18-75 years
* the patient who need to arterial line

Exclusion Criteria:

* allergy to nicardipine
* history of peripheral artery disease
* BMI \> 40 kg/m2
* unwilling to participate or denial of informed consent

Primary outcomes:
measure: Success rate of radial artery cannulation since first skin puncture
timeFrame: 10 minute from puncture at skin
Secondary outcomes:
measure: radial artery diameter
timeFrame: Pre-induction to 3 minute after subcutaneous infiltration
measure: Time from first skin puncture to success cannulation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology Department
Study officials:
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
name: Phuriphon Songarj, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02621138: The Influence of Muscle Contraction on the Cardiac Autonomic System
Official title: The Influence of Muscle Contraction on the Cardiac Autonomic System at Rest and Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with cerebral palsy

Brief summary: Population:

16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.

All children aged 6-12 yrs who understand simple commands.

Tools:

1. Polar monitor to record heart rate, attached to chest, in use throughout testing
2. Dynamometer- for assessing muscle strength.
3. Weights

Method:

Each child will be tested once. Both tools will be demonstrated and tried out before actual testing.

With Polar watch attached:

1. 5 min sitting at rest,
2. knee muscle strength assessment with the dynamometer,
3. 15 minutes rest
4. Isometric and isotonic knee muscle contraction at 30% of childs' maximal strength as has assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5 minutes rest in-between All will be perform in both legs.


Eligibility criteria: Inclusion Criteria:

* GMFCS I-II
* Unilateral CP

Exclusion Criteria:

* Heart problems

Primary outcomes:
measure: Heart rate
timeFrame: 40 minutes
measure: Heart rate variability
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Children's Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT00730938: The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Official title: The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Endophthalmitis
Keywords: fibrin
endophthalmitis
cataract extraction
Lens
implantation,
intraocular
Lead sponsor: Presbyterian Church East Africa Kikuyu Hospital
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.

Detailed description: The study investigates whether using an antibiotic (cefuroxime) in the anterior chamber of the eye at the end of surgery for cataract in children will reduce the amount of fibrin formation.

Eligibility criteria: Inclusion Criteria:

* bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

* traumatic cataract

Primary outcomes:
measure: Fibrin formation in anterior chamber
timeFrame: 4th postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Kikuyu
country: Kenya
facility: Presbyterian Church East Africa Kikuyu Hospital
Study officials:
affiliation: PCEA Kikuyu Hospital
name: Dan Gradin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gradin D, Mundia D. Effect of intracameral cefuroxime on fibrinous uveitis after pediatric cataract surgery. J Pediatr Ophthalmol Strabismus. 2011 Jan-Feb;48(1):45-9. doi: 10.3928/01913913-20100420-03. Epub 2010 Apr 22.